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End-stage Renal DiseasePhase 2CONVERTNCT04523220

Study to Investigate the Safety of a Drug Called Osocimab at Low and High Doses in Adult Patients With Kidney Failure Requiring Regular Hemodialysis

A Phase 2 study testing BAY1213790 (Osocimab) in people with End-stage Renal Disease and Prevention of Thromboembolic Events, run by Bayer at 151 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

In this study researchers want to learn about the safety of drug Osocimab at lower-dose and higher-doses in adult participants with kidney disease undergoing regular dialysis (a procedure that uses a machine to get rid of toxins and extra fluids in the blood). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BAY1213790 (Osocimab)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
704 participants
Where
151 sitesin 19 countries
Study dates
28 Aug 2020to 30 May 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must be at least 18 years of age
  • Patients with end-stage renal disease on hemodialysis (including hemodiafiltration) for ≥3 months, receiving dialysis at least 9 hours a week and stable in the view of the investigator
  • Body weight of at least 50 kg
  • Male and/or female. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Who cannot join

  • Recent (<6 months before screening) clinically significant bleeding
  • Hemoglobin (Hb) < 9.0 g/dL at screening
  • Platelet count < 100 x 10^9/L
  • aPTT or PT > ULN (upper limit of normal)
  • Hepatic disease associated with ALT > 3x ULN, or total bilirubin >2x ULN with direct bilirubin > 20% of the total
  • Sustained uncontrolled hypertension (diastolic blood pressure ≥100 mmHg and/or systolic blood pressure ≥ 180 mmHg)
Show all 14Show fewer
  • Known intracranial neoplasm, arteriovenous malformation or aneurysm
  • Known bleeding disorders e.g. von-Willebrand disease or Hemophilia A, B or C
  • Recent (<3 months before screening) thromboembolic event, e.g. acute coronary syndrome, stroke or VTE (except dialysis access thrombosis)
  • Recent (<3 months before screening) major surgery or scheduled major surgery during study participation
  • Scheduled living donor renal transplant during study participation
  • Persistent heart failure as classified by the New York Heart Association (NYHA) classification of 3 or higher
  • Receiving antiplatelet therapy except daily ASA ≤ 150 mg/day
  • Receiving anticoagulation in therapeutic doses, other than standard anticoagulation during the hemodialysis procedure

Trial locations and contacts

151 sites in 19 countries.

151 sites in 19 countries

United States26 sites

  • Renal Medicine Associates

    Albuquerque, New Mexico, 87109

  • ARA Augusta

    Augusta, Georgia, 30901

  • Waterloo Dialysis

    Austin, Texas, 78756

  • Fresenius North Austin Dialysis Center

    Austin, Texas, 78758

  • North America Research Institute - Azusa

    Azusa, California, 91702

  • Fresenius Kidney Care Baton Rouge Mancuso Lane

    Baton Rouge, Louisiana, 70808

  • Fresenius Kidney Care - Brawley

    Brawley, California, 92227

  • Liberty Dialysis- Caldwell

    Caldwell, Idaho, 83605

  • Durham Nephrology Associates, Pa

    Durham, North Carolina, 27704

  • ARA Plantation Dialysis, LLC

    Ellenton, Florida, 34222

  • DaVita South Valley Dialysis

    Encino, California, 91316

  • Fresenius Kidney Care Evergreen Park

    Evergreen Park, Illinois, 60805

  • DaVita Butler Farm Dialysis

    Hampton, Virginia, 23666

  • ARA Holyoke Dialysis Center

    Holyoke, Massachusetts, 01040

  • Fresenius Kidney Care - Mission Bend (FMCNA #3971)

    Houston, Texas, 77083

  • Davita Hospital Hill Dialysis

    Kansas City, Missouri, 64108

  • Fresenius Kidney Care - La Mesa

    La Mesa, California, 91942

  • East L.A. Dialysis Center

    Los Angeles, California, 90022

  • Van Buren Dialysis Center

    Riverside, California, 92503

  • Fresenius Kidney Care Kearny Mesa

    San Diego, California, 92111

  • FMC San Ysidro

    San Diego, California, 92154

  • Fresenius Kidney Care South Dialysis

    Shreveport, Louisiana, 71106

  • Liberty Dialysis St. George

    St. George, Utah, 84790

  • Fresenius Kidney Care Sugar Land

    Sugar Land, Texas, 77479

  • DaVita Greater Waterbury Dialysis

    Waterbury, Connecticut, 06708

  • Queen's Dialysis Unit

    West Covina, California, 91790

Other trials in United States

Japan14 sites

  • Takemura Medical Nephro Clinic

    Kanuma, Tochigi, 322-0029

  • Saiyu Clinic

    Koshigaya, Saitama, 343-0823

  • Akebono Clinic

    Kumamoto, 861-4112

  • Kyoto Station Takeda Dialysis Clinic

    Kyoto, 600-8216

  • Nagaoka Red Cross Hospital

    Nagaoka, Niigata, 940-2085

  • Akagaki Clinic

    Osaka, 543-0052

  • Ibaraki Seinan Medical Center Hospital

    Sashima-gun, Ibaraki, 306-0433

  • Futakotamagawaekimae clinic

    Setagaya-ku, Tokyo, 158-0094

  • Katta General Hospital

    Shiraishi, Miyagi, 989-0231

  • Tsuchiura Beryl Clinic

    Tsuchiura, Ibaraki, 300-0062

  • Ohishi Naika Clinic

    Tsuchiura, Ibaraki, 300-0835

  • Kikuchi Medical Clinic

    Tsukuba, Ibaraki, 305-0861

  • Saint Hill Hospital

    Ube, Yamaguchi, 755-0155

  • Yabuki Hospital

    Yamagata, 990-0885

Other trials in Japan

Ukraine13 sites

  • Brovarskaya multidisciplinary clinical hospital

    Brovary, 07400

  • Medical center LLC " Fresenius medical care Ukraine"

    Cherkasy, 18009

  • Dnepropetrovsk regional hospital n.a. I. I. Mechnikov

    Dnipro, 49005

  • Regional Clinical Hospital - Ivano-Frankivsk

    Ivano-Frankivsk, 76000

  • Kharkiv regional Clinical Centre of urology and nephrology

    Kharkiv, 61037

  • Kyiv City Center of Nephrology and Dialysis

    Kyiv, 02660

  • State Institution "Institute of Nephrology" NAMS of Ukraine

    Kyiv, 04050

  • Lutsk city clinical hospital

    Lutsk, 43024

  • Mykolaiv Regional Clinical Hospital

    Mykolaiv, 54058

  • Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi

    Poltava, 36011

  • Transcarpatian Regional Clinical Hospital

    Uzhhorod, 88018

  • Vinnitsa Regional Clinical Hospital im. N.I. Pirogov

    Vinnytsia, 21018

  • Zaporizhzhia Regional Clinical Hospital

    Zaporizhzhya, 69600

Other trials in Ukraine

Russia11 sites

  • Chelyabinsk Regional Clinical Hospital

    Chelyabinsk, 454076

  • LLC Dialysis center

    Kolomna, 140402

  • LLC Fresenius medical care Kuban

    Krasnodar, 350029

  • LLC Dialysis center

    Mytishchi, 141007

  • City Clinical Hospital #1 Orenburg

    Orenburg, 460040

  • Republican Hospital n.a. V.A. Baranov

    Petrozavodsk, 185019

  • Kupchinsky center for outpatient dialysis

    Saint Petersburg, 192102

  • LLC B. Brown Avitum Russland Clinics

    Saint Petersburg, 193318

  • City Hospital #31

    Saint Petersburg, 197110

  • LLC Yaroslavl dialysis center

    Yaroslavl, 150062

  • Sverdlovsk Regional Clinical Hospital #1

    Yekaterinburg, 620102

Other trials in Russia

Portugal10 sites

  • SPD - Amadora (Diaverum Amadora)

    Amadora, Lisbon District, 2700-001

  • Diaverum Aveiro

    Aveiro, 3800-266

  • Caledial - Centro de Hemodialise de Gaia

    Canelas, Porto District, 4410-313

  • CHLO - Hospital Santa Cruz

    Carnaxide, Lisbon District, 2795-53

  • Pluribus Dialise - Cascais (DaVita)

    Cascais, Lisbon District, 2750-663

  • Eurodial Obidos (DaVita)

    Gaeiras - Obidos, Leiria District, 2510-702

  • Eurodial Leiria (DaVita)

    Leiria, 2400-441

  • NephroCare APDP

    Lisbon, 1250-191

  • Pluribus Dialise - Sacavem (DaVita)

    Sacavém, Lisbon District, 2685-005

  • Centro Hospitalar do Medio Tejo | Unidade de Torres Novas - Nephrology Department

    Torres Novas, Santarém District, 2350-754

Other trials in Portugal

Greece7 sites

  • General Hospital of Arta

    Arta, 47100

  • HIPPOKRATION General Hospital of Athens

    Athens, 115 27

  • General Hospital of Athens LAIKO

    Athens, 11527

  • Ioannina University General Hospital

    Ioannina, 45500

  • University General Hospital of Larissa

    Larissa, 41110

  • Hippokration General Hospital of Thessaloniki

    Thessaloniki, 54642

  • General Hospital of Thessaloniki Papageorgiou

    Thessaloniki, 56403

Other trials in Greece

Hungary7 sites

  • Bajai Szent Rokus Korhaz

    Baja, 6500

  • Fresenius Medical Care Egeszsegugyi Kft.

    Budapest, 1083

  • Eszak-Pesti Centrumkorhaz-Honvedkorhaz

    Budapest, 1134

  • Csongrad Megyei Egeszsegugyi Ellato Kozpont,Hodmezovasarhely

    Hódmezővásárhely, 6800

  • Keszthelyi Korhaz

    Keszthely, 8360

  • Fresenius Medical Care Egeszsegugyi Kft.

    Miskolc, 3526

  • Fresenius Medical Care Egeszsegugyi Kft.

    Pécs, 7624

Other trials in Hungary

Israel7 sites

  • Barzilai Medical Center | Nephrology & Hypertension Dept.

    Ashkelon, 7830604

  • Lady Davis Carmel Medical Center

    Haifa, 3436212

  • Health Corporation of Galilee Medical Center

    Nahariya, 2210001

  • Rabin Medical Center, HaSharon (Golda) Campus

    Petah Tikva, 4937211

  • Clalit Health Services Rabin Medical Center-Beilinson Campus

    Petah Tikva, 4941492

  • Poriya Medical Center | Nephrology and Hypertension Dept.

    Tiberius, 1528001

  • Shamir Medical Center (Assaf Harofeh)

    Tsrifin, 7030000

Other trials in Israel

Italy7 sites

  • A.O.U. di Bologna Policlinico S.Orsola Malpighi

    Bologna, Emilia-Romagna, 40138

  • A.O.U. Careggi

    Florence, Tuscany, 50134

  • IRCCS Ospedale Policlinico San Martino

    Genoa, Liguria, 16132

  • A.O.U. di Parma

    Parma, Emilia-Romagna, 43126

  • IRCCS Istituti Clinici Scientifici Maugeri SpA SB

    Pavia, Lombardy, 27100

  • AUSL-IRCCS di Reggio Emilia

    Reggio Emilia, Emilia-Romagna, 42123

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Lazio, 00168

Other trials in Italy

Spain7 sites

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Clinico Universitario San Carlos | Nefrologia

    Madrid, 28040

  • Hospital Althaia, Xarxa Assistencial de Manresa

    Manresa, Barcelona, 08243

  • Corporació Sanitària Parc Taulí

    Sabadell, Barcelona, 08208

  • Hospital Clínico Universitario de Santiago de Compostela

    Santiago de Compostela, A Coruña, 15706

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitario Dr. Peset

    Valencia, 46017

Other trials in Spain

Turkey (Türkiye)7 sites

  • Hacettepe Universitesi Tip Fakultesi

    Ankara, 06230

  • Adnan Menderes Universitesi Tip fakultesi

    Aydin, 09100

  • Turk Bobrek Vakfi Memorial Hizmet Hastanesi

    Istanbul, 34180

  • Sisli Hamidiye Etfal Egitim ve Arastirma Hastanesi

    Istanbul, 34418

  • Erciyes Universitesi Tip Fakultesi

    Kayseri, 38039

  • Kocaeli Universitesi Tip Fakultesi

    Kocaeli, 41380

  • Inonu Universitesi Tip Fakultesi

    Malatya, 44280

Other trials in Turkey (Türkiye)

Belgium6 sites

  • Epicura

    Baudour, 7331

  • Imeldaziekenhuis - St-Elisabethkliniek

    Bonheiden, 2820

  • AZ St-Lucas Campus St-Lucas

    Ghent, 9000

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • CHU de Liege | CHR Citadel - Department of Nephrology

    Liège, 4000

  • AZ Nikolaas Campus Sint-Niklaas

    Sint-Niklaas, 9100

Other trials in Belgium

Netherlands6 sites

  • Academisch Medisch Centrum (AMC)

    Amsterdam, 1105 AZ

  • Gelre Ziekenhuizen

    Apeldoorn, 7334 DZ

  • Deventer Ziekenhuis

    Deventer, 7416 SE

  • Albert Schweitzer Ziekenhuis, Dordwijk

    Dordrecht, 3318 AT

  • Catharina Ziekenhuis

    Eindhoven, 5623 EJ

  • Maasstad Ziekenhuis | Neurology Department

    Rotterdam, 3079DZ

Other trials in Netherlands

Bulgaria5 sites

  • MHAT Sveti Ivan Rilski 2003

    Dupnitsa, 2600

  • MHAT Haskovo

    Haskovo, 6300

  • UMHAT Kanev AD

    Rousse, 7002

  • MHAT Shumen AD

    Shumen, 9700

  • Multiprofile Hospital for Active Treatment Hristo Botev AD

    Vratsa, 3000

Other trials in Bulgaria

Poland5 sites

  • NZOZ Nowy Szpital w Swieciu Sp. z o.o.

    Gmina Świecie, 86-100

  • Wojewodzki Szpital Zespolony

    Kielce, 25-736

  • Stacja Dializ Olkusz

    Olkusz, 32-300

  • Stacja Dializ W-wa Mangalia

    Warsaw, 02-758

  • Stacja Dializ Zyrardow

    Żyrardów, 96-300

Other trials in Poland

Australia4 sites

  • Eastern Health Integrated Renal Service

    Box Hill, 3128

  • John Hunter Hospital

    New Lambton Heights, 2305

  • Sydney Adventist Hospital

    Wahroonga, New South Wales, 2076

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Austria4 sites

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt, Carinthia, 9020

  • Privatklinik Wehrle-Diakonissen

    Salzburg, 5026

  • Klinik Landstraße - Krankenhaus Rudolfstiftung

    Vienna, 1030

  • Universitätsklinikum AKH Wien

    Vienna, 1090

Other trials in Austria

Czechia4 sites

  • Krajska Nemocnice Liberec

    Liberec, 460 63

  • Fakultni nemocnice Ostrava

    Ostrava, 708 52

  • Privamed s.r.o.

    Pilsen, 323 33

  • Fresenius Nephro Care s.r.o. - Sokolov

    Sokolov, 356 01

Other trials in Czechia

Lithuania1 site

  • LUHS Kauno Hospital (Josvainiu str.)

    Kaunas, LT-47116

Other trials in Lithuania

About this study

Official title: A Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center Study to Assess the Safety and Tolerability of Monthly Subcutaneous Administrations of a Low and High Dose Cohort of Osocimab to ESRD Patients on Regular Hemodialysis

In this study researchers want to learn about the safety of drug Osocimab at lower-dose and higher-doses in adult participants with kidney disease undergoing regular dialysis (a procedure that uses a machine to get rid of toxins and extra fluids in the blood). Patients with kidney disease undergoing regular dialysis are at high risk for heart and blood vessels diseases. Osocimab is a human monoclonal antibody under development for the prevention of events caused by blood clots like heart attack, stroke and death due to heart or blood vessels diseases. It works by binding to and blocking the activated form of clotting factor XI which increases the formation and stability of clots. Researchers also want to find out how drug Osocimab works in human body and how the body absorbs, distributes and excretes the drug.

Participants in this study will receive monthly injection of either Osocimab at a lower-dose or higher-dose or placebo (a placebo looks like a treatment but does not have any medicine in it). Both Osocimab and placebo will be injected into the tissue under the skin of the belly. Observation for each participant will last up to 23 months. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.

Being tested
BAY1213790 (Osocimab), Placebo
Keywords
End-stage renal disease (ESRD), Hemodialysis
Medical subject headings
Kidney Failure, Chronic

What participants receive

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

  • BAY1213790 (Osocimab)Drug

    Single loading dose as subcutaneous abdominal injection followed by monthly maintenance doses.

  • PlaceboDrug

    Subcutaneous administration in the same manner as Osocimab.

Study groups in NCT04523220
Study groupRoleWhat they receive
BAY1213790 low doseExperimentalParticipants will receive Osocimab (BAY1213790) 105 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 52.5 mg until the end of the extension treatment period.
Receives: Drug: BAY1213790 (Osocimab)
Placebo low dosePlacebo comparatorPlacebo will be administered subcutaneously in the same manner as Osocimab.
Receives: Drug: Placebo
BAY1213790 high doseExperimentalParticipants will receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg until the end of the extension treatment period.
Receives: Drug: BAY1213790 (Osocimab)
Placebo high doseExperimentalPlacebo will be administered subcutaneously in the same manner as Osocimab.
Receives: Drug: Placebo

What is being measured

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

  1. Cumulative Incidence Risk of the First Composite of Major Bleeding (MB) and Clinically-relevant Non-major Bleeding (CRNMB) Events as Assessed by Blinded Central Independent Adjudication Committee (CIAC)

    Cumulative incidence risk of the first Composite of MB and CRNMB (ISTH) at month 6 is reported in the table.

    Descriptive time to composite of MB and CRNMB Events is reported in statistical analysis.

    Descriptive time to composite of treatment emergent major and CRNMB events [in alignment with International Society on Thrombosis and Haemostatsis (ISTH) guidelines] analyses were performed. The cumulative incidence function for the event-of-interest together with the corresponding confidence interval were estimated for each treatment arm using Aalen-Johansen estimators. Cumulative incidence of events up to the day, inclusive.

    Measured: From the first dose of study intervention up till 30 days after last study intervention in the main treatment period, up to 6 months

  2. Cumulative Incidence Risk of Composite of Moderate and Severe Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Cumulative incidence risk of composite of moderate and severe AEs and SAEs at month 6 is reported in the table.

    Descriptive time to the composite of Moderate and Severe AEs and SAEs is reported in statistical analysis.

    An AE was any untoward medical occurrence in a patient or clinical study participant, whether or not considered related to the study intervention.

    Measured: From the first dose of study intervention up until 30 days after last study intervention in the main treatment period, up to 6 months

Secondary outcomes (2)

  1. Ratio of Activated Partial Thromboplastin Time (aPTT) at 6 Months Trough Levels Versus Baseline.

    The aPTT at trough levels after 6 months were analyzed as ratio to baseline by providing the Geometric Mean (Standard Deviation).

    aPTT was measured via the kaolin-trigger method (clotting assay).

    Measured: At 6 months (Visit 19 / Day 30 of the 6th month)

  2. Ratio of Factor XI (FXI) Activity at 6 Months Trough Levels Versus Baseline

    The Factor XI (FXI) activity at trough levels after 6 months were analyzed as ratio to baseline by providing the Geometric Mean (Standard Deviation).

    Factor XI activity was assessed with an aPTT-based coagulation test using FXI deficient plasma.

    Measured: At 6 months (Visit 19 / Day 30 of the 6th month)

Timeline

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

  1. First posted21 Aug 2020
  2. Study start28 Aug 2020
  3. Primary completion28 Dec 2021
  4. Study completion30 May 2022

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
704 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04523220
Sponsor's protocol ID
20115
Other IDs
2019-003957-27, 2019
Acronym
CONVERT
Status last verified
Jul 2023
First submitted
20 Aug 2020
Last updated
21 Jul 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: There are no current plans to share data.

Publications

  • Weitz JI, Tanko LB, Floege J, Fox KAA, Bhatt DL, Thadhani R, Hung J, Pap AF, Kubitza D, Winkelmayer WC; CONVERT Investigators. Anticoagulation with osocimab in patients with kidney failure undergoing hemodialysis: a randomized phase 2 trial. Nat Med. 2024 Feb;30(2):435-442. doi: 10.1038/s41591-023-02794-7. Epub 2024 Feb 16.

    PubMed 38365952

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BAY1213790 (Osocimab) in people with End-stage Renal Disease and Prevention of Thromboembolic Events, run by Bayer at 151 sites in 19 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 4 inclusion and 14 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: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 151 sites in United States, Japan, Ukraine, Russia, Portugal and 14 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative Incidence Risk of the First Composite of Major Bleeding (MB) and Clinically-relevant Non-major Bleeding (CRNMB) Events as Assessed by Blinded Central Independent Adjudication Committee (CIAC) (time frame: From the first dose of study intervention up till 30 days after last study intervention in the main treatment period, up to 6 months). The study lists 2 primary outcomes in all. 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 NCT04523220, which also lists 1 linked publication.

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 21 Jul 2023.

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