Renal Insufficiency, ChronicPhase 3NCT07624305

A Phase III Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With CKD Stage 3b and 4 (BalanceD-CKD)

A Phase 3 study testing Balcinrenone/dapagliflozin and Dapagliflozin in people with Renal Insufficiency, Chronic, run by AstraZeneca at 478 sites in 27 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of balcinrenone in fixed combination with dapagliflozin, compared with dapagliflozin, in patients with CKD Stage 3b and 4 (eGFR ≥ 15 to < 45 mL/min/1.73 m2) administered orally once daily in addition to SoC. Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Renal Insufficiency, Chronic
What is being tested?: Balcinrenone/dapagliflozin and Dapagliflozin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2,800 participants
Where: 478 sitesin 27 countries
Study dates: 1 Sep 2026to 1 Jul 2030
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 years
Diagnosis of CKD and at least one of the following:
eGFR ≥ 15 to < 45 mL/min/1.73 m2 AND: UACR ≥ 30 mg/g (central laboratory) or UACR ≥ 100 mg/g (local laboratory ) or UPCR ≥ 200 mg/g (local laboratory).
eGFR ≥ 15 to < 30 mL/min/1.73 m2 and UACR < 30 mg/g (local or central laboratory UACR value).
Serum/plasma K+ ≤ 5.0 mmol/L
Maximum tolerated dose of an ACEi or an ARB, unless contraindicated or not tolerated. The dose should be stable for at least 4 weeks before screening.

Who cannot join

Recent (within 90 days prior to screening) or ongoing dialysis, or likely to require dialysis within 3 months following randomisation
UACR ≥ 5000 mg/g or UPCR ≥ 7000 mg/g at screening.
SBP > 180 mmHg or DBP > 110 mmHg at screening.
SBP < 90 mmHg at screening.
HbA1c > 9% at screening
T1DM, except:

Show all 22Show fewer

For US only: patients with T1DM treated with SGLT2i for at least 4 months prior to screening, without DKA during that period, and who have experience with ketone monitoring are eligible.
For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months prior to Screening, without DKA during the period of dapagliflozin treatment are eligible for inclusion.
Autosomal dominant polycystic kidney disease.
Major cardiac or valvular surgery, acute coronary syndrome (myocardial infarction or unstable angina), stroke, transient ischaemic attack within 12 weeks prior to screening.
Severe hepatic impairment (Child-Pugh Class C).
Adrenal insufficiency.
Clinically significant acute kidney injury within 12 weeks prior to the screening.
New York Heart Association functional HF class IV at screening, or hospitalisation for heart failure within 4 weeks prior to screening.
Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months) prior to screening.
Solid organ or bone marrow transplant or a plan for transplant within 6 months following randomisation.
Any use of the following medications and supplements:
MRAs
Aldosterone analogues
Aldosterone synthase inhibitors
Any use of potassium binders within 2 weeks prior to screening. Use is allowed after randomisation.
Strong or moderate inducers or inhibitors of CYP3A4, prohibited at least one week prior to randomisation

Trial locations and contacts

478 sites in 27 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

+18772409479

information.center@astrazeneca.com

AstraZeneca Clinical AstraZeneca Clinical contact

+18772409479

information.center@astrazeneca.com

Country

City, postcode or hospital

Sites recruiting now only

478 sites in 27 countries

United States69 sites, 67 recruiting

Research Site
Albany, New York, 12209
Not yet recruiting
Research Site
Albuquerque, New Mexico, 87108
Not yet recruiting
Research Site
Ann Arbor, Michigan, 48105
Not yet recruiting
Research Site
Arlington, Virginia, 22205
Not yet recruiting
Research Site
Asheville, North Carolina, 28805
Not yet recruiting
Research Site
Boca Raton, Florida, 33487
Not yet recruiting
Research Site
Brunswick, Georgia, 31520
Not yet recruiting
Research Site
Charlotte, North Carolina, 28287
Recruiting
Research Site
Chattanooga, Tennessee, 37404
Not yet recruiting
Research Site
Cincinnati, Ohio, 45212
Not yet recruiting
Research Site
Cincinnati, Ohio, 45220
Not yet recruiting
Research Site
Columbia, South Carolina, 29209
Not yet recruiting
Research Site
Concord, California, 94520
Recruiting
Research Site
Daly City, California, 94015
Not yet recruiting
Research Site
East Point, Georgia, 30344
Not yet recruiting
Research Site
Fort Lauderdale, Florida, 33316
Not yet recruiting
Research Site
Fort Worth, Texas, 76104
Recruiting
Research Site
Fremont, California, 94538
Not yet recruiting
Research Site
Gainesville, Florida, 32608
Not yet recruiting
Research Site
Greenville, South Carolina, 29607
Not yet recruiting
Research Site
Hollywood, Florida, 33021
Not yet recruiting
Research Site
Houston, Texas, 77043
Not yet recruiting
Research Site
Huntington Park, California, 90255
Not yet recruiting
Research Site
Huntsville, Alabama, 35805
Not yet recruiting
Research Site
Iowa City, Iowa, 52246
Not yet recruiting
Research Site
Irving, Texas, 75063
Not yet recruiting
Research Site
Jacksonville Beach, Florida, 32250
Not yet recruiting
Research Site
Kansas City, Missouri, 64111
Not yet recruiting
Research Site
Lakeland, Florida, 33813
Not yet recruiting
Research Site
Lancaster, California, 93534
Not yet recruiting
Research Site
Little Rock, Arkansas, 72205
Not yet recruiting
Research Site
Long Island City, New York, 11106
Not yet recruiting
Research Site
Louisville, Kentucky, 40205
Recruiting
Research Site
Lufkin, Texas, 75904
Not yet recruiting
Research Site
Lynwood, California, 90262
Not yet recruiting
Research Site
Macon, Georgia, 31210
Not yet recruiting
Research Site
Mankato, Minnesota, 56001
Not yet recruiting
Research Site
McKinney, Texas, 75069
Not yet recruiting
Research Site
Media, Pennsylvania, 19063
Not yet recruiting
Research Site
Melbourne, Florida, 32901
Suspended
Research Site
Northridge, California, 91324
Not yet recruiting
Research Site
Oak Brook, Illinois, 60523
Not yet recruiting
Research Site
Orlando, Florida, 32806
Not yet recruiting
Research Site
Palo Alto, California, 94304
Not yet recruiting
Research Site
Pasadena, Texas, 77504
Recruiting
Research Site
Pomona, California, 91768
Not yet recruiting
Research Site
Port Charlotte, Florida, 33952
Not yet recruiting
Research Site
Richmond, Virginia, 23249
Not yet recruiting
Research Site
Riverside, California, 92506
Not yet recruiting
Research Site
Riverview, Florida, 33578
Recruiting
Research Site
Rockford, Illinois, 61107
Not yet recruiting
Research Site
Saint Joseph, Michigan, 49085
Not yet recruiting
Research Site
Salem, Virginia, 24153
Withdrawn
Research Site
San Antonio, Texas, 78204
Not yet recruiting
Research Site
San Antonio, Texas, 78212
Not yet recruiting
Research Site
San Dimas, California, 91773
Not yet recruiting
Research Site
Savannah, Georgia, 31406
Recruiting
Research Site
Sherman, Texas, 75092
Not yet recruiting
Research Site
Stephenville, Texas, 76401
Recruiting
Research Site
Sugar Land, Texas, 77478
Not yet recruiting
Research Site
Sugar Land, Texas, 77478
Recruiting
Research Site
Surprise, Arizona, 85374
Recruiting
Research Site
Tarzana, California, 91356
Not yet recruiting
Research Site
Tempe, Arizona, 85284
Not yet recruiting
Research Site
The Bronx, New York, 10468
Not yet recruiting
Research Site
Washington D.C., District of Columbia, 20422
Not yet recruiting
Research Site
Weston, Florida, 33331
Not yet recruiting
Research Site
Wichita, Kansas, 67214
Not yet recruiting
Research Site
Woodbridge, Virginia, 22192
Not yet recruiting

Other trials in United States

China65 sites, 65 recruiting

Research Site
Baotou, 014010
Not yet recruiting
Research Site
Beijing, 100029
Not yet recruiting
Research Site
Beijing, 100044
Not yet recruiting
Research Site
Beijing, 100053
Not yet recruiting
Research Site
Beijing, 102218
Not yet recruiting
Research Site
Changchun, 130041
Not yet recruiting
Research Site
Changsha, 410015
Not yet recruiting
Research Site
Changzhou, 213000
Not yet recruiting
Research Site
Changzhou, 213100
Not yet recruiting
Research Site
Chengdu, 610041
Not yet recruiting
Research Site
Chengdu, 611130
Not yet recruiting
Research Site
Chongqing, 400010
Not yet recruiting
Research Site
Dongguan, 523009
Not yet recruiting
Research Site
Dongyang, 322100
Not yet recruiting
Research Site
Ganzhou, 341000
Not yet recruiting
Research Site
Guangzhou, 510280
Not yet recruiting
Research Site
Guangzhou, 510800
Not yet recruiting
Research Site
Guiyang, 550044
Not yet recruiting
Research Site
Hebei, 050071
Not yet recruiting
Research Site
Hohhot, 750306
Not yet recruiting
Research Site
Huaian, 223300
Not yet recruiting
Research Site
Jinan, 250014
Not yet recruiting
Research Site
Jining, 272006
Not yet recruiting
Research Site
Jiujiang, 332000
Not yet recruiting
Research Site
Linhai, 317000
Not yet recruiting
Research Site
Nanchang, 330006
Not yet recruiting
Research Site
Nanjing, 210011
Not yet recruiting
Research Site
Nanjing, 210029
Not yet recruiting
Research Site
Nanning, 530000
Not yet recruiting
Research Site
Nanning, 530022
Not yet recruiting
Research Site
Ningbo, 315000
Not yet recruiting
Research Site
Ningbo, 315010
Not yet recruiting
Research Site
Ningbo, 315100
Not yet recruiting
Research Site
Ningbo, 315800
Not yet recruiting
Research Site
Panjin, 124000
Not yet recruiting
Research Site
Pingxiang, 337055
Not yet recruiting
Research Site
Qingzhou, 262550
Not yet recruiting
Research Site
Shanghai, 200032
Not yet recruiting
Research Site
Shanghai, 200050
Not yet recruiting
Research Site
Shanghai, 200090
Not yet recruiting
Research Site
Shanghai, 200092
Not yet recruiting
Research Site
Shanghai, 200233
Not yet recruiting
Research Site
Shanghai, 200240
Not yet recruiting
Research Site
Shanghai, 201199
Not yet recruiting
Research Site
Shanghai, 201210
Not yet recruiting
Research Site
Shantou, 515065
Not yet recruiting
Research Site
Shenyang, 110004
Not yet recruiting
Research Site
Shenzhen, 518036
Not yet recruiting
Research Site
Shenzhen, 518053
Not yet recruiting
Research Site
Suzhou, 215004
Not yet recruiting
Research Site
Ürümqi, 831118
Not yet recruiting
Research Site
Wuhan, 430010
Not yet recruiting
Research Site
Wuhan, 430060
Not yet recruiting
Research Site
Wuxi, 214023
Not yet recruiting
Research Site
Xiamen, 361004
Not yet recruiting
Research Site
Xiamen, 361101
Not yet recruiting
Research Site
Xuzhou, 221000
Not yet recruiting
Research Site
Yancheng, 224005
Not yet recruiting
Research Site
Yangzhou, 225000
Not yet recruiting
Research Site
Yangzhou, 225001
Not yet recruiting
Research Site
Yantai, 264000
Not yet recruiting
Research Site
Yibin, 644000
Not yet recruiting
Research Site
Yinchuan, 750000
Not yet recruiting
Research Site
Zhenjiang, 212002
Not yet recruiting
Research Site
Zhuzhou, 412007
Not yet recruiting

Other trials in China

Japan38 sites, 38 recruiting

Research Site
Ageo, 362-8588
Recruiting
Research Site
Asahi-shi, 289-2511
Recruiting
Research Site
Chiba, 260-8712
Not yet recruiting
Research Site
Fukaya, 366-0052
Not yet recruiting
Research Site
Fukui-shi, 910-8526
Not yet recruiting
Research Site
Izumisano, 598-8577
Not yet recruiting
Research Site
Izunokuni-shi, 410-2295
Not yet recruiting
Research Site
Kariya, 448-8505
Recruiting
Research Site
Kisarazu-shi, 292-8535
Not yet recruiting
Research Site
Kita-ku, 144-0001
Recruiting
Research Site
Kitakyusyu-shi, 806-8501
Not yet recruiting
Research Site
Kofu, 400-8506
Not yet recruiting
Research Site
Koga-shi, 306-0232
Recruiting
Research Site
Komatsu-shi, 923-8560
Not yet recruiting
Research Site
Koshigaya-shi, 343-8577
Recruiting
Research Site
Kumagaya-shi, 360-0197
Not yet recruiting
Research Site
Kumamoto, 860-0008
Recruiting
Research Site
Kurashiki Shi, 701 0192
Not yet recruiting
Research Site
Kuwana-shi, 511-0061
Recruiting
Research Site
Kyoto, 606-8507
Not yet recruiting
Research Site
Kyoto, 607-8062
Not yet recruiting
Research Site
Matsumoto-shi, 390-8621
Not yet recruiting
Research Site
Minamiuonuma, 949-7302
Not yet recruiting
Research Site
Minatoku, 105-8471
Not yet recruiting
Research Site
Minokamo Shi, 505-8510
Recruiting
Research Site
Morioka, 020-0066
Not yet recruiting
Research Site
Nagoya, 453-8511
Not yet recruiting
Research Site
Nagoya, 457-8511
Not yet recruiting
Research Site
Naka, 311-0113
Recruiting
Research Site
Nerima-ku, 177-8521
Not yet recruiting
Research Site
Osaka, 530-0012
Not yet recruiting
Research Site
Osaka, 553-0003
Not yet recruiting
Research Site
Sendai, 982-8502
Recruiting
Research Site
Takatsuki-shi, 569-8686
Not yet recruiting
Research Site
Toride-shi, 302-0022
Not yet recruiting
Research Site
Tsu, 514-8507
Not yet recruiting
Research Site
Urayasu, 279-0001
Recruiting
Research Site
Yokohama, 236-0004
Not yet recruiting

Other trials in Japan

Germany29 sites, 29 recruiting

Research Site
Aachen, 52074
Not yet recruiting
Research Site
Bad Nenndorf, 31542
Not yet recruiting
Research Site
Berlin, 10787
Not yet recruiting
Research Site
Berlin, 12203
Not yet recruiting
Research Site
Berlin, 13509
Not yet recruiting
Research Site
Bonn, 53127
Not yet recruiting
Research Site
Brandenburg an der Havel, 14770
Not yet recruiting
Research Site
Braunschweig, 38126
Not yet recruiting
Research Site
Cloppenburg, 49661
Not yet recruiting
Research Site
Essen, 45122
Not yet recruiting
Research Site
Frankfurt am Main, 60590
Not yet recruiting
Research Site
Fulda, 36037
Not yet recruiting
Research Site
Gladbeck, 45968
Not yet recruiting
Research Site
Goslar, 38642
Not yet recruiting
Research Site
Hanover, 30625
Not yet recruiting
Research Site
Heidelberg, 69120
Not yet recruiting
Research Site
Leipzig, 04129
Not yet recruiting
Research Site
Magdeburg, 39120
Not yet recruiting
Research Site
München, 81377
Not yet recruiting
Research Site
München, 81675
Not yet recruiting
Research Site
Münster, 48153
Not yet recruiting
Research Site
Nuremberg, 90443
Not yet recruiting
Research Site
Nuremberg, 90471
Not yet recruiting
Research Site
Obertshausen, 63179
Not yet recruiting
Research Site
Riesa, 01589
Not yet recruiting
Research Site
Rostock, 18057
Not yet recruiting
Research Site
Rotenburg (Wümme), 27356
Not yet recruiting
Research Site
Villingen-Schwenningen, 78052
Not yet recruiting
Research Site
Würzburg, 97080
Not yet recruiting

Other trials in Germany

India23 sites, 23 recruiting

Research Site
Aligarh, 202002
Not yet recruiting
Research Site
Belagavi, 590010
Not yet recruiting
Research Site
Bhubaneswar, 751019
Not yet recruiting
Research Site
Calicut, 673 008
Not yet recruiting
Research Site
Coimbatore, 641018
Not yet recruiting
Research Site
Dehli, 110075
Not yet recruiting
Research Site
Dehradun, 248001
Not yet recruiting
Research Site
Hyderabad, 500084
Not yet recruiting
Research Site
Jaipur, 302017
Not yet recruiting
Research Site
Jodhpur, 342005
Not yet recruiting
Research Site
Kanpur, 208002
Not yet recruiting
Research Site
Kochi, 682041
Not yet recruiting
Research Site
Kolkata, 700014
Not yet recruiting
Research Site
Mumbai, 400012
Not yet recruiting
Research Site
Mumbai, 400026
Not yet recruiting
Research Site
Mysore, 570001
Not yet recruiting
Research Site
Nagpur, 440001
Not yet recruiting
Research Site
New Delhi, 110001
Not yet recruiting
Research Site
New Delhi, 110017
Not yet recruiting
Research Site
New Delhi, 110029
Not yet recruiting
Research Site
Pune, 411013
Not yet recruiting
Research Site
Thiruvananthapuram, 695011
Not yet recruiting
Research Site
Vijayawada, 520 008
Not yet recruiting

Other trials in India

Canada17 sites, 16 recruiting

Research Site
Brampton, Ontario, L6T 0H9
Not yet recruiting
Research Site
Calgary, Alberta, T2R0X7
Withdrawn
Research Site
Edmonton, Alberta, T6G 2P4
Not yet recruiting
Research Site
Greater Sudbury, Ontario, P3E 5J1
Not yet recruiting
Research Site
Halifax, Nova Scotia, B3H 2Y9
Not yet recruiting
Research Site
London, Ontario, N6A 5A5
Not yet recruiting
Research Site
Mississauga, Ontario, L5M 2S6
Not yet recruiting
Research Site
Montreal, Quebec, H1T 2M4
Not yet recruiting
Research Site
Montreal, Quebec, H2X 0A9
Not yet recruiting
Research Site
Montreal, Quebec, H3G 1A4
Not yet recruiting
Research Site
Montreal, Quebec, H4J 1C5
Not yet recruiting
Research Site
Oakville, Ontario, L6M 0L8
Not yet recruiting
Research Site
Québec, Quebec, G1R 2J6
Not yet recruiting
Research Site
Toronto, Ontario, M4G 3E8
Not yet recruiting
Research Site
Toronto, Ontario, M5G 2C4
Not yet recruiting
Research Site
Waterloo, Ontario, N2T 0C1
Recruiting
Research Site
Winnipeg, Manitoba, R2V 3M3
Not yet recruiting

Other trials in Canada

Taiwan16 sites, 16 recruiting

Research Site
Changhua, 500
Not yet recruiting
Research Site
Hualien City, 970473
Not yet recruiting
Research Site
Kaohsiung City, 813
Not yet recruiting
Research Site
Kaohsiung City, 833
Not yet recruiting
Research Site
New Taipei City, 220216
Not yet recruiting
Research Site
Taichung, 40201
Not yet recruiting
Research Site
Taichung, 404
Not yet recruiting
Research Site
Taichung, 40705
Not yet recruiting
Research Site
Taichung, 433004
Recruiting
Research Site
Tainan, 70403
Not yet recruiting
Research Site
Tainan, 710
Not yet recruiting
Research Site
Taipei, 100
Recruiting
Research Site
Taipei, 110
Not yet recruiting
Research Site
Taipei, 116
Not yet recruiting
Research Site
Taoyuan, 333
Not yet recruiting
Research Site
Zhubei, 302
Recruiting

Other trials in Taiwan

Brazil15 sites, 15 recruiting

Research Site
Barretos, 14784-400
Not yet recruiting
Research Site
Belém, 66073-005
Not yet recruiting
Research Site
Belo Horizonte, 30140-085
Not yet recruiting
Research Site
Belo Horizonte, 30455-610
Not yet recruiting
Research Site
Campinas, 13060-080
Not yet recruiting
Research Site
Goiânia, 74605-020
Not yet recruiting
Research Site
Natal, 59020-500
Not yet recruiting
Research Site
Recife, 50720-110
Not yet recruiting
Research Site
São Caetano do Sul, 09521-160
Not yet recruiting
Research Site
São José do Rio Preto, 15015-750
Not yet recruiting
Research Site
São José dos Campos, 12243-280
Not yet recruiting
Research Site
São Paulo, 01139-000
Not yet recruiting
Research Site
São Paulo, 03164-000
Not yet recruiting
Research Site
São Paulo, 04039-004
Not yet recruiting
Research Site
São Paulo, 05651-002
Not yet recruiting

Other trials in Brazil

South Korea14 sites, 14 recruiting

Research Site
Anyang, 14068
Not yet recruiting
Research Site
Cheonan-si, 31151
Not yet recruiting
Research Site
Seoul, 03181
Not yet recruiting
Research Site
Seoul, 03312
Not yet recruiting
Research Site
Seoul, 04401
Not yet recruiting
Research Site
Seoul, 05278
Not yet recruiting
Research Site
Seoul, 06351
Not yet recruiting
Research Site
Seoul, 07061
Not yet recruiting
Research Site
Seoul, 07345
Not yet recruiting
Research Site
Seoul, 08308
Not yet recruiting
Research Site
Seoul, 3722
Not yet recruiting
Research Site
Seoul, 4763
Not yet recruiting
Research Site
Wŏnju, 26426
Not yet recruiting
Research Site
Yangsan, 50612
Not yet recruiting

Other trials in South Korea

France13 sites, 13 recruiting

Research Site
Boulogne-sur-Mer, 62200
Not yet recruiting
Research Site
Caen, 14000
Not yet recruiting
Research Site
Cherbourg, 50102
Not yet recruiting
Research Site
Colmar, 68024
Not yet recruiting
Research Site
La Roche-sur-Yon, 85025
Not yet recruiting
Research Site
Le Mans, 72037
Not yet recruiting
Research Site
Marseille, 13385
Not yet recruiting
Research Site
Nîmes, 30000
Not yet recruiting
Research Site
Orléans, 45100
Not yet recruiting
Research Site
Rouen, 76031
Not yet recruiting
Research Site
Saint-Priez En Jarez, 42270
Not yet recruiting
Research Site
Toulouse, 31059
Not yet recruiting
Research Site
Tours, 37000
Not yet recruiting

Other trials in France

Ukraine13 sites, 13 recruiting

Research Site
Ivano-Frankivsk, 76018
Not yet recruiting
Research Site
Kyiv, 01601
Not yet recruiting
Research Site
Kyiv, 02002
Not yet recruiting
Research Site
Kyiv, 03037
Not yet recruiting
Research Site
Kyiv, 03049
Not yet recruiting
Research Site
Kyiv, 03151
Not yet recruiting
Research Site
Kyiv, 04050
Not yet recruiting
Research Site
Kyiv, 04114
Not yet recruiting
Research Site
Kyiv, 04210
Not yet recruiting
Research Site
Lviv, 79016
Not yet recruiting
Research Site
Vinnytsia, 21001
Not yet recruiting
Research Site
Vinnytsia, 21009
Not yet recruiting
Research Site
Vinnytsia, 21029
Not yet recruiting

Other trials in Ukraine

Argentina12 sites, 12 recruiting

Research Site
CABA, C1431FWO
Not yet recruiting
Research Site
Capital Federal, C1014A
Not yet recruiting
Research Site
Ciudad de Buenos Aires, C1425AGC
Not yet recruiting
Research Site
La Plata, B1900AVG
Not yet recruiting
Research Site
Lanús Este, B1824KAJ
Not yet recruiting
Research Site
Mar del Plata, 7600
Not yet recruiting
Research Site
Rosario, 2000
Not yet recruiting
Research Site
Rosario, S2000CVD
Not yet recruiting
Research Site
Rosario, S2000PBJ
Not yet recruiting
Research Site
San Nicolás, B2900DMH
Not yet recruiting
Research Site
Santa Fe, S3000FWO
Not yet recruiting
Research Site
Santa Fe, S3000
Not yet recruiting

Other trials in Argentina

Italy12 sites, 12 recruiting

Research Site
Bari, 70124
Not yet recruiting
Research Site
Bologna, 40138
Not yet recruiting
Research Site
Cosenza, 87100
Not yet recruiting
Research Site
Cremona, 26100
Not yet recruiting
Research Site
Genoa, 16132
Not yet recruiting
Research Site
Milan, 20122
Not yet recruiting
Research Site
Modena, 41125
Not yet recruiting
Research Site
Naples, 80138
Not yet recruiting
Research Site
Palermo, 90127
Not yet recruiting
Research Site
Pavia, 27100
Not yet recruiting
Research Site
Ranica, 24020
Not yet recruiting
Research Site
Verona, 37126
Not yet recruiting

Other trials in Italy

Mexico12 sites, 12 recruiting

Research Site
Benito Juárez, 03330
Not yet recruiting
Research Site
Culiacán, 80000
Not yet recruiting
Research Site
Culiacán, 80230
Not yet recruiting
Research Site
Durango, 34200
Not yet recruiting
Research Site
Ecatepec de Morelos, 55000
Not yet recruiting
Research Site
Estado de México, 50090
Not yet recruiting
Research Site
México, 14080
Not yet recruiting
Research Site
Mexico City, 0 3100
Not yet recruiting
Research Site
Tuxpan, 92830
Not yet recruiting
Research Site
Veracruz, 91855
Not yet recruiting
Research Site
Villahermosa, 86000
Not yet recruiting
Research Site
Xalapa, 91020
Not yet recruiting

Other trials in Mexico

Peru12 sites, 12 recruiting

Research Site
Callao, Bellavista
Not yet recruiting
Research Site
Chorrillos, Lima 9
Not yet recruiting
Research Site
Cusco, CUSCO 01
Not yet recruiting
Research Site
Lima, 14
Not yet recruiting
Research Site
Lima, 15038
Not yet recruiting
Research Site
Lima, 15072
Not yet recruiting
Research Site
Lima, 15082
Not yet recruiting
Research Site
Lima, 15088
Not yet recruiting
Research Site
Lima, 15131
Not yet recruiting
Research Site
Lima, LIMA 27
Not yet recruiting
Research Site
Piura, 20001
Not yet recruiting
Research Site
Trujillo, 130101
Not yet recruiting

Other trials in Peru

Spain12 sites, 12 recruiting

Research Site
Badajoz, 06080
Not yet recruiting
Research Site
Barcelona, 08003
Not yet recruiting
Research Site
Barcelona, 08035
Not yet recruiting
Research Site
Barcelona, 08036
Not yet recruiting
Research Site
Córdoba, 14004
Not yet recruiting
Research Site
Girona, 17007
Not yet recruiting
Research Site
Madrid, 28006
Not yet recruiting
Research Site
Madrid, 28040
Not yet recruiting
Research Site
Majadahonda, 28222
Not yet recruiting
Research Site
Talavera de la Reina, 45600
Not yet recruiting
Research Site
Valencia, 46010
Not yet recruiting
Research Site
Valencia, 46026
Not yet recruiting

Other trials in Spain

Bulgaria11 sites, 11 recruiting

Research Site
Blagoevgrad, 2700
Not yet recruiting
Research Site
Nova Zagora, 8900
Not yet recruiting
Research Site
Pleven, 5800
Not yet recruiting
Research Site
Plovdiv, 4000
Not yet recruiting
Research Site
Sandanski, 2800
Not yet recruiting
Research Site
Sevlievo, 5403
Not yet recruiting
Research Site
Sofia, 1000
Not yet recruiting
Research Site
Sofia, 1407
Not yet recruiting
Research Site
Sofia, 1527
Not yet recruiting
Research Site
Stara Zagora, 6000
Not yet recruiting
Research Site
Varna, 9010
Not yet recruiting

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Greece11 sites, 11 recruiting

Research Site
Athens, 10676
Not yet recruiting
Research Site
Athens, 11527
Not yet recruiting
Research Site
Athens, 12462
Not yet recruiting
Research Site
Heraklion, 71409
Not yet recruiting
Research Site
Heraklion, 71500
Not yet recruiting
Research Site
Ioannina, 455 00
Not yet recruiting
Research Site
Larissa, 41110
Not yet recruiting
Research Site
Marousi, 151 23
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Research Site
Piraeus, 18454
Not yet recruiting
Research Site
Rio, 265 04
Not yet recruiting
Research Site
Thessaloniki, 54629
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Thailand11 sites, 11 recruiting

Research Site
Bangkok, 10210
Not yet recruiting
Research Site
Bangkok, 10300
Not yet recruiting
Research Site
Bangkok, 10400
Not yet recruiting
Research Site
Bangkok, 10700
Not yet recruiting
Research Site
Banphaeo, 74120
Not yet recruiting
Research Site
Changwat Sara Buri, 18000
Not yet recruiting
Research Site
Chiang Mai, 50200
Not yet recruiting
Research Site
Hat Yai, 90110
Not yet recruiting
Research Site
Naimuang, 30000
Not yet recruiting
Research Site
Phitsanulok, 65000
Not yet recruiting
Research Site
Ubonratchathani, 34000
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Vietnam11 sites, 11 recruiting

Research Site
Can Tho, 900000
Not yet recruiting
Research Site
Da Nang, 550000
Not yet recruiting
Research Site
Da Nang, 55000
Not yet recruiting
Research Site
Hà Nội, 100000
Not yet recruiting
Research Site
Hanoi, 100000
Not yet recruiting
Research Site
Hanoi, 10000
Not yet recruiting
Research Site
Ho Chi Minh City, 7000000
Not yet recruiting
Research Site
Ho Chi Minh City, 700000
Not yet recruiting
Research Site
Hochiminh, 70000
Not yet recruiting
Research Site
Hochiminh City, 700000
Not yet recruiting
Research Site
Huế, 530000
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Austria10 sites, 10 recruiting

Research Site
Feldkirch, 6807
Not yet recruiting
Research Site
Innsbruck, 6020
Not yet recruiting
Research Site
Linz, 4020
Not yet recruiting
Research Site
Sankt Pölten, 3100
Not yet recruiting
Research Site
Vienna, 1030
Not yet recruiting
Research Site
Vienna, 1130
Not yet recruiting
Research Site
Vienna, 1190
Not yet recruiting
Research Site
Vienna, A-1090
Not yet recruiting
Research Site
Wels, 4600
Not yet recruiting
Research Site
Wiener Neustadt, 2700
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Malaysia10 sites, 10 recruiting

Research Site
Cheras, 56000
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Research Site
Ipoh, 30990
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Kajang, 43000
Not yet recruiting
Research Site
Kota Kinabalu, 88200
Not yet recruiting
Research Site
Kuala Lumpur, 50586
Not yet recruiting
Research Site
Kuala Lumpur, 59100
Not yet recruiting
Research Site
Kuantan, 25100
Not yet recruiting
Research Site
Muar town, 84000
Not yet recruiting
Research Site
Sarawak Miri, 98000
Not yet recruiting
Research Site
Sungai Buloh, 47000
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Turkey (Türkiye)10 sites, 10 recruiting

Research Site
Adapazarı, 54290
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Research Site
Ankara, 06800
Not yet recruiting
Research Site
Antalya, 07059
Not yet recruiting
Research Site
Dinar, 03400
Not yet recruiting
Research Site
İzmit, 41380
Not yet recruiting
Research Site
Kahramanmaraş, 46100
Not yet recruiting
Research Site
Kayseri, 38039
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Research Site
Kazımkarabekir, 01230
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Research Site
Malatya, 44280
Not yet recruiting
Research Site
Samsun, 55139
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United Kingdom10 sites, 10 recruiting

Research Site
Aberdeen, AB25 2ZN
Recruiting
Research Site
Bristol, BS1 3NU
Recruiting
Research Site
Cardiff, CF14 4XW
Not yet recruiting
Research Site
Dundee, DD1 9SY
Recruiting
Research Site
Glasgow, G51 4TF
Recruiting
Research Site
London, E1 1FR
Recruiting
Research Site
London, NW3 2QG
Not yet recruiting
Research Site
London, SE5 9RS
Recruiting
Research Site
London, SW170QT
Not yet recruiting
Research Site
Swansea, SN6 6NL
Recruiting

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Philippines8 sites, 8 recruiting

Research Site
Dasmariñas, 4114
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Research Site
Davao DEL SUR, 8000
Not yet recruiting
Research Site
Iloilo City, 5000
Not yet recruiting
Research Site
Las Piñas, 1742
Not yet recruiting
Research Site
Manila, 1000
Not yet recruiting
Research Site
Quezon City, 1101
Not yet recruiting
Research Site
Quezon City, 1112
Not yet recruiting
Research Site
West San Juan City, 1502
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Romania8 sites, 8 recruiting

Research Site
Brasov, 500388
Not yet recruiting
Research Site
Bucharest, 022328
Not yet recruiting
Research Site
Bucharest, 031441
Not yet recruiting
Research Site
Bucharest, 22328
Not yet recruiting
Research Site
Craiova, 200515
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Research Site
Galati, 800183
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Research Site
Oradea, 410469
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Research Site
Timișoara, 300736
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Poland6 sites, 6 recruiting

Research Site
Olsztyn, 10-561
Not yet recruiting
Research Site
Warsaw, 02-507
Not yet recruiting
Research Site
Warsaw, 04-141
Not yet recruiting
Research Site
Węgrów, 07-100
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Wroclaw, 53-114
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Research Site
Żywiec, 34-300
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About this study

Official title: A Phase III, Randomised, Double-blind, Study to Evaluate the Effect of Balcinrenone/Dapagliflozin Compared With Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Chronic Kidney Disease (Stage 3b and 4)

This is a population with high unmet medical need and an increased risk of CKD progression, who are frequently excluded from interventional trials.

Read the detailed description

This is a Phase III, multicentre, randomised, double-blind, double-dummy, parallel-group, active-controlled, event-driven study in participants with CKD Stage 3b and 4.

The purpose of this study is to determine if balcinrenone/dapagliflozin, compared with dapagliflozin, administered as a capsule once daily on a background of standard of care (SoC) therapy, reduces the risk of CV death, death from kidney failure, kidney failure, sustained ≥ 50% decline from baseline in eGFR, and HF events in adults with CKD Stage 3b and 4. The study will also assess safety and tolerability of balcinrenone/dapagliflozin.

Eligible patients will randomly be assigned with a 1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments:

Balcinrenone/dapagliflozin 15 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet
Dapagliflozin 10 mg tablet and matching placebo for balcinrenone/dapagliflozin capsule The study will be conducted at approximately 550 sites in approximately 30 countries, globally.

Conditions: Renal Insufficiency, Chronic
Being tested: Balcinrenone/dapagliflozin, Dapagliflozin, Placebo matching Dapagliflozin, Placebo matching balcinrenone/dapagliflozin
Medical subject headings: Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Balcinrenone/dapagliflozinDrug
balcinrenone/dapagliflozin 15 mg/10 mg
DapagliflozinDrug
dapagliflozin 10 mg
Placebo matching DapagliflozinDrug
matching placebo for dapagliflozin 10 mg
Placebo matching balcinrenone/dapagliflozinDrug
matching placebo for balcinrenone/dapagliflozin

Study groups in NCT07624305
Study group	Role	What they receive
Balcinrenone/dapagliflozin	Experimental	Patient receives once daily 1 capsule balcinrenone 15 mg and dapagliflozin 10 mg and 1 placebo tablet matching dapagliflozin. Receives: Drug: Balcinrenone/dapagliflozin; Drug: Placebo matching Dapagliflozin
Dapagliflozin	Active comparator	Patient receives once daily 1 placebo capsule matching balcinrenone and dapagliflozin and 1 tablet dapagliflozin 10 mg. Receives: Drug: Dapagliflozin; Drug: Placebo matching balcinrenone/dapagliflozin

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to first occurrence of cardiovascular death, death from kidney failure, kidney failure, sustained 50% or greater decline in eGFR, and heart failure event
Time from randomization to first occurrence of any of the components of the composite:
- CV death
- Death from kidney failure
- Onset of kidney failure
- Initiation of maintenance dialysis or
- Kidney transplantation
- Sustained ≥ 50% decline from baseline in eGFR
- HF with or without hospitalisation
Measured: Up to 46 months.

Secondary outcomes (5)

Time to first occurrence of cardiovascular death, death from kidney failure, kidney failure and sustained 50% or greater decline in eGFR.
Time from randomization to first occurrence of any of the components of the composite:
- CV death
- Death from kidney failure
- Onset of kidney failure:
- Initiation of maintenance dialysis or
- Kidney transplantation Sustained ≥ 50% decline from baseline in eGFR
Measured: Up to 46 months.
Change in urinary albumin to creatinine ratio to Week 24
Change from baseline to Week 24 in urinary albumin to creatinine ratio
Measured: Baseline to Week 24
Time to first occurrence of cardiovascular death or heart failure event.
Time from randomization to first occurrence of any of the components of the composite:
- CV death
- HF with or without hospitalisation
Measured: Up to 46 months.
Time to cardiovascular death
Time from randomization to cardiovascular death.
Measured: Up to 46 months.
Time to death from any cause
Time from randomization to death from any cause.
Measured: Up to 46 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20261 Jul 2030

First posted3 Jun 2026
Study start1 Sep 2026
Primary completion1 Jul 2030 (estimated)
Study completion1 Jul 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 2,800 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07624305
Sponsor's protocol ID: D8790C00001
Other IDs: 2026-526114-90-00
Status last verified: Sep 2026
First submitted: 29 May 2026
Last updated: 24 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Researchers may see summary results, but they will not be able to see individual participant data or any personal identifiers.

Interested in taking part?

AstraZeneca Clinical Study Information Center

+18772409479

information.center@astrazeneca.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases

All Renal Insufficiency, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomised, Double-blind, Study to Evaluate the Effect of Balcinrenone/Dapagliflozin Compared With Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Chronic Kidney Disease (Stage 3b and 4)
ClinicalTrials.gov ID: NCT07624305
Acronym / sponsor ID: D8790C00001
Conditions: Renal Insufficiency, Chronic
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 2,800 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 1 Sep 2026 (actual)
Primary completion: 1 Jul 2030 (estimated)
Study completion: 1 Jul 2030 (estimated)
First posted: 3 Jun 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a population with high unmet medical need and an increased risk of CKD progression, who are frequently excluded from interventional trials.

Detailed description

This is a Phase III, multicentre, randomised, double-blind, double-dummy, parallel-group, active-controlled, event-driven study in participants with CKD Stage 3b and 4.

Eligible patients will randomly be assigned with a 1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments:

Balcinrenone/dapagliflozin 15 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet
Dapagliflozin 10 mg tablet and matching placebo for balcinrenone/dapagliflozin capsule The study will be conducted at approximately 550 sites in approximately 30 countries, globally.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Parallel groups

Arm	Type	Receives
Balcinrenone/dapagliflozin	Experimental	Drug: Balcinrenone/dapagliflozin, Drug: Placebo matching DapagliflozinPatient receives once daily 1 capsule balcinrenone 15 mg and dapagliflozin 10 mg and 1 placebo tablet matching dapagliflozin.
Dapagliflozin	Active comparator	Drug: Dapagliflozin, Drug: Placebo matching balcinrenone/dapagliflozinPatient receives once daily 1 placebo capsule matching balcinrenone and dapagliflozin and 1 tablet dapagliflozin 10 mg.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Age ≥ 18 years
Diagnosis of CKD and at least one of the following:
Serum/plasma K+ ≤ 5.0 mmol/L
Maximum tolerated dose of an ACEi or an ARB, unless contraindicated or not tolerated. The dose should be stable for at least 4 weeks before screening.

Key exclusion criteria (22 listed)

Recent (within 90 days prior to screening) or ongoing dialysis, or likely to require dialysis within 3 months following randomisation
UACR ≥ 5000 mg/g or UPCR ≥ 7000 mg/g at screening.
SBP > 180 mmHg or DBP > 110 mmHg at screening.
SBP < 90 mmHg at screening.
HbA1c > 9% at screening

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Balcinrenone/dapagliflozinbalcinrenone/dapagliflozin 15 mg/10 mg	Drug	Balcinrenone/dapagliflozin
Dapagliflozindapagliflozin 10 mg	Drug	Dapagliflozin
Placebo matching Dapagliflozinmatching placebo for dapagliflozin 10 mg	Drug	Balcinrenone/dapagliflozin
Placebo matching balcinrenone/dapagliflozinmatching placebo for balcinrenone/dapagliflozin	Drug	Dapagliflozin

Primary outcome

Time to first occurrence of cardiovascular death, death from kidney failure, kidney failure, sustained 50% or greater decline in eGFR, and heart failure event
Time frame: Up to 46 months.
Time from randomization to first occurrence of any of the components of the composite: * CV death * Death from kidney failure * Onset of kidney failure * Initiation of maintenance dialysis or * Kidney transplantation * Sustained ≥ 50% decline from baseline in eGFR * HF with or without hospitalisation

5 secondary outcomes

Time to first occurrence of cardiovascular death, death from kidney failure, kidney failure and sustained 50% or greater decline in eGFR.
Time frame: Up to 46 months.
Change in urinary albumin to creatinine ratio to Week 24
Time frame: Baseline to Week 24
Time to first occurrence of cardiovascular death or heart failure event.
Time frame: Up to 46 months.
Time to cardiovascular death
Time frame: Up to 46 months.
Time to death from any cause
Time frame: Up to 46 months.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
Individual participant dataSharing planned: No. Researchers may see summary results, but they will not be able to see individual participant data or any personal identifiers.

Related trials for Renal Insufficiency, Chronic

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

AstraZeneca Clinical Study Information Center contact

+18772409479

information.center@astrazeneca.com

AstraZeneca Clinical AstraZeneca Clinical contact

+18772409479

information.center@astrazeneca.com

478 sites in 27 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Balcinrenone/dapagliflozin and Dapagliflozin in people with Renal Insufficiency, Chronic, run by AstraZeneca at 478 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 478 sites in United States, China, Japan, Germany, India and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (+18772409479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first occurrence of cardiovascular death, death from kidney failure, kidney failure, sustained 50% or greater decline in eGFR, and heart failure event (time frame: Up to 46 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07624305.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.