Immunoglobulin A NephropathyPhase 3I CANNCT06291376

Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

A Phase 3 study testing Ravulizumab in people with Immunoglobulin A Nephropathy and IgAN, run by Alexion Pharmaceuticals, Inc. at 246 sites in 28 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The primary objective of this study to evaluate efficacy of ravulizumab compared with placebo on proteinuria reduction and change in eGFR in adult participants with IgAN who are at risk of disease progression. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Immunoglobulin A Nephropathy, IgAN
What is being tested?: Ravulizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 584 participants
Where: 246 sitesin 28 countries
Study dates: 29 Mar 2024to 18 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Documentation of IgAN diagnosis established on kidney biopsy obtained any time prior to or during the Screening Period for participants with eGFR ≥ 30 mL/min/1.73 m^2.
For participants in the AdKD cohorts, eGFR 20 to 29 mL/min/1.73 m2 a kidney biopsy is required within 6 months prior to Screening or during the Screening Period.
UPCR ≥ 0.75 g/g or UP ≥1 g/day calculated from the mean of two 24-hour urine during the Screening Period.
Estimated GFR ≥ 30 mL/min/1.73 m2 at Screening.
Stable and maximum allowed or tolerated RAASI (ACEI and/or ARB) dose for ≥ 3 months prior to Screening with no planned change during Screening through Week 106.
Participants who are receiving SGLT2I, DEARA, MRA or ERA must be on a stable and maximum allowed or tolerated dose for ≥ 3 months prior to Screening with no planned change in dose through Week 106.

Who cannot join

Diagnosis of rapid progressive glomerulonephritis as measured by eGFR loss ≥ 50% over a period of 3 months prior to Screening.
Secondary IgAN (eg, due to systemic lupus erythematosus (SLE), cirrhosis, or celiac disease; IgAV-N may be eligible).
Concomitant clinically significant renal disease other than IgAN.
Prior use of immunosuppressive treatment within 3 months of screening.
Uncontrolled diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8.5%.
Henoch-Schonlein purpura (IgAV) requiring systemic immunosuppressive therapy within 12 months of Screening.

Show all 10Show fewer

History of kidney transplant or planned kidney transplant during the Treatment Period.
Splenectomy or functional asplenia.
History of Neisseria meningitidis infection.
Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization.

Trial locations and contacts

246 sites in 28 countries.

Country

City, postcode or hospital

246 sites in 28 countries

United States39 sites

Research Site
Acworth, Georgia, 30101
Research Site
Alabaster, Alabama, 35007
Research Site
Albany, New York, 12208
Research Site
Arlington, Texas, 76002
Research Site
Atlanta, Georgia, 30322
Research Site
Bay Pines, Florida, 33744
Research Site
Boston, Massachusetts, 02111
Research Site
Boston, Massachusetts, 02114
Research Site
Boston, Massachusetts, 02115
Research Site
Charlottesville, Virginia, 22908
Research Site
Columbus, Ohio, 43210
Research Site
Houston, Texas, 77030
Research Site
Houston, Texas, 77054
Research Site
Kansas City, Missouri, 64111
Research Site
Knoxville, Tennessee, 37920
Research Site
Lawrenceville, Georgia, 30046
Research Site
Los Angeles, California, 90022
Research Site
Los Angeles, California, 90027
Research Site
Los Angeles, California, 90095
Research Site
Miami, Florida, 33136
Research Site
Milwaukee, Wisconsin, 53226
Research Site
Minneapolis, Minnesota, 55435
Research Site
Minneapolis, Minnesota, 55455
Research Site
New Orleans, Louisiana, 70121
Research Site
New York, New York, 10016
Research Site
North Las Vegas, Nevada, 89086
Research Site
Orange, California, 92868
Research Site
Orlando, Florida, 32806
Research Site
Phoenix, Arizona, 85054
Research Site
San Antonio, Texas, 78229
Research Site
San Bernardino, California, 92408
Research Site
San Diego, California, 92120
Research Site
San Francisco, California, 94143
Research Site
Shenandoah, Texas, 77384
Research Site
Stanford, California, 94305
Research Site
The Bronx, New York, 10468
Research Site
Torrance, California, 90502
Research Site
Valencia, California, 91355
Research Site
Worcester, Massachusetts, 01655

Other trials in United States

China35 sites

Research Site
Baotou, 14010
Research Site
Beijing, 100029
Research Site
Beijing, 100034
Research Site
Beijing, 100044
Research Site
Changsha, 410013
Research Site
Changzhou, 272100
Research Site
Chengdu, 610000
Research Site
Chengdu, 610072
Research Site
Chongqing, 400010
Research Site
Guangzhou, 510100
Research Site
Hangzhou, 310003
Research Site
Jinan, 250021
Research Site
Jinhua, 321000
Research Site
Lanzhou, 730000
Research Site
Luoyang, 471000
Research Site
Nanchang, 330006
Research Site
Nanchang, 330008
Research Site
Nanjing, 210009
Research Site
Nanjing, 210011
Research Site
Nanjing, 210029
Research Site
Ningbo, 315010
Research Site
Qingdao, 110016
Research Site
Shanghai, 200025
Research Site
Shanghai, 200040
Research Site
Shanghai, 200065
Research Site
Shenzhen, 518036
Research Site
Shenzhen, 518053
Research Site
Ürümqi, 831118
Research Site
Wuhan, 430060
Research Site
Wuxi, 214023
Research Site
Xi'an, 710061
Research Site
Yantai, 264000
Research Site
Yibin, 610500
Research Site
Yinchuan, 750004
Research Site
Zhengzhou, 450052

Other trials in China

Japan15 sites

Research Site
Bunkyō City, 113-8431
Research Site
Chiba, 260-8677
Research Site
Chiba, 260-8712
Research Site
Fukuoka, 815-8555
Research Site
Kamakura, 247-8533
Research Site
Kasugai-shi, 486-8510
Research Site
Kitakyushu-shi, 802-8555
Research Site
Kobe, 650-0047
Research Site
Matsumoto-shi, 390-8621
Research Site
Matsuyama, 790-8524
Research Site
Nagoya, 466-8650
Research Site
Osaka, 534-0021
Research Site
Osaka, 545-8586
Research Site
Sapporo, 060-8604
Research Site
Urayasu-shi, 279-0021

Other trials in Japan

France12 sites

Research Site
Amiens, 80054
Research Site
Bayonne, 64100
Research Site
Brest, 29200
Research Site
Chambéry, 73011
Research Site
Le Kremlin-Bicêtre, 94270
Research Site
Marseille, 13385
Research Site
Nantes, 44093
Research Site
Paris, 75010
Research Site
Paris, 75015
Research Site
Saint-Priest-en-Jarez, 42270
Research Site
Strasbourg, 67091
Research Site
Toulouse, 31059

Other trials in France

Italy12 sites

Research Site
Agrigento, 92100
Research Site
Bologna, 40138
Research Site
Brescia, 25123
Research Site
Cagliari, 09121
Research Site
Florence, 50134
Research Site
Milan, 20122
Research Site
Milan, 20132
Research Site
Padova, 35128
Research Site
Parma, 43126
Research Site
Torino, 10154
Research Site
Torrette, 60126
Research Site
Verona, 37126

Other trials in Italy

Spain11 sites

Research Site
A Coruña, 15006
Research Site
Alcalá de Henares, 28805
Research Site
Lleida, 25198
Research Site
Madrid, 28031
Research Site
Madrid, 28040
Research Site
Málaga, 29010
Research Site
Murcia, 30120
Research Site
Oviedo, 33011
Research Site
Seville, 41013
Research Site
Tarragona, 09-43005
Research Site
Zaragoza, 50009

Other trials in Spain

Brazil10 sites

Research Site
Belo Horizonte, 30110-934
Research Site
Belo Horizonte, 30150-221
Research Site
Botucatu, 18618-687
Research Site
Curitiba, 80440-020
Research Site
Fortaleza, 60430-270
Research Site
Recife, 50670-901
Research Site
Ribeirão Preto, 14051-140
Research Site
São José do Rio Preto, 15090-000
Research Site
São Paulo, 04038-002
Research Site
São Paulo, 05403-000

Other trials in Brazil

Germany10 sites

Research Site
Aachen, 52074
Research Site
Berlin, 10117
Research Site
Erlangen, 91054
Research Site
Essen, 45122
Research Site
Greifswald, 17475
Research Site
Hanover, 30625
Research Site
Mainz, 55131
Research Site
München, 81377
Research Site
München, 81657
Research Site
Villingen-Schwenningen, 78052

Other trials in Germany

Poland10 sites

Research Site
Bialystok, 15-276
Research Site
Bialystok, 15-540
Research Site
Krakow, 31-513
Research Site
Lodz, 92-213
Research Site
Lublin, 20-090
Research Site
Olsztyn, 10-561
Research Site
Poznan, 60-355
Research Site
Szczecin, 70-111
Research Site
Warsaw, 02-006
Research Site
Warsaw, 02-507

Other trials in Poland

Taiwan10 sites

Research Site
Kaohsiung City, 80756
Research Site
Kaohsiung City, 81362
Research Site
Kaohsiung City, 833401
Research Site
New Taipei City, 220
Research Site
New Taipei City, 23561
Research Site
Taichung, 40705
Research Site
Taichung
Research Site
Tainan, 70403
Research Site
Taipei, 10002
Research Site
Taoyuan, 333

Other trials in Taiwan

South Korea9 sites

Research Site
Anyang-si, 14068
Research Site
Busan, 49241
Research Site
Deagu, 41944
Research Site
Gwangju, 61469
Research Site
Gyeonggi-do, 13620
Research Site
Seoul, 03080
Research Site
Seoul, 03722
Research Site
Seoul, 05278
Research Site
Suwon, 16499

Other trials in South Korea

Australia8 sites

Research Site
Canberra, 2605
Research Site
Clayton, 3168
Research Site
Concord, 2139
Research Site
Herston, 4029
Research Site
Liverpool, 2170
Research Site
Perth, 6000
Research Site
Southport, 4222
Research Site
St Albans, 3021

Other trials in Australia

Turkey (Türkiye)7 sites

Research Site
Ankara, 06560
Research Site
Bursa, 16059
Research Site
Istanbul, 34098
Research Site
Istanbul, 34452
Research Site
Kayseri, 38039
Research Site
Kocaeli, 41380
Research Site
Konya, 42080

Other trials in Turkey (Türkiye)

United Kingdom7 sites

Research Site
Cambridge, CB2 0QQ
Research Site
Doncaster, DN2 5LT
Research Site
Leicester, Le5 4PW
Research Site
London, E1 1FR
Research Site
Manchester, M13 9WL
Research Site
Reading, RG1 5AN
Research Site
Stevenage, SG1 4AB

Other trials in United Kingdom

Argentina5 sites

Research Site
Ciudad de Buenos Aires, C1015ABO
Research Site
Ciudad de Buenos Aires, C1425AGC
Research Site
Córdoba, X5016KET
Research Site
La Plata, B1902COS
Research Site
Rosario, 2000

Other trials in Argentina

Chile5 sites

Research Site
Araucania, 4781151
Research Site
Providencia, 7500000
Research Site
Santiago, 7500922
Research Site
Santiago, 8330034
Research Site
Valdivia, 5090146

Other trials in Chile

Israel5 sites

Research Site
Haifa, 3109601
Research Site
Jerusalem, 91120
Research Site
Nazareth, 16100
Research Site
Petah Tikva, 49372
Research Site
Tel Aviv, 6423906

Other trials in Israel

Thailand5 sites

Research Site
Bangkok, 10330
Research Site
Bangkok, 10400
Research Site
Bangkok, 10700
Research Site
Chiang Mai, 50200
Research Site
Khon Kaen, 40002

Other trials in Thailand

Canada4 sites

Research Site
Brampton, Ontario, L6T 0H9
Research Site
London, Ontario, N6A 5W9
Research Site
Toronto, Ontario, M5G 2C4
Research Site
Winnipeg, Manitoba, R2V 3M3

Other trials in Canada

Greece4 sites

Research Site
Athens, 11527
Research Site
Athens, 12462
Research Site
Heraklion, 71500
Research Site
Thessaloniki, 57010

Other trials in Greece

Malaysia4 sites

Research Site
Ipoh, 30990
Research Site
Johor Bahru, 80100
Research Site
Kuala Lumpur, 59100
Research Site
Seremban, 70300

Other trials in Malaysia

Saudi Arabia4 sites

Research Site
Dammam, 31444
Research Site
Jeddah, 21499
Research Site
Riyadh, 11211
Research Site
Riyadh, 12231

Other trials in Saudi Arabia

Austria3 sites

Research Site
Graz, 8036
Research Site
Innsbruck, 6020
Research Site
Linz, 4020

Other trials in Austria

Belgium3 sites

Research Site
Brussels, 1090
Research Site
Edegem, 2650
Research Site
Leuven, 3000

Other trials in Belgium

Czechia3 sites

Research Site
Nový Jičín, 74101
Research Site
Prague, 128 00
Research Site
Prague, 140 00

Other trials in Czechia

Hong Kong2 sites

Research Site
Hong Kong, 999077
Research Site
Hong Kong

Other trials in Hong Kong

Netherlands2 sites

Research Site
Amsterdam, 1105 AZ
Research Site
Rotterdam, 3045 PM

Other trials in Netherlands

Slovakia2 sites

Research Site
Banská Bystrica, 974 01
Research Site
Martin, 03659

Other trials in Slovakia

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Immunoglobulin A Nephropathy (IgAN)

Read the detailed description

The I CAN study will enroll approximately 510 eligible participants with IgAN who are high risk of disease progression. Participants will be on stable concomitant IgAN treatment(s) consistent with standard of care for patients with IgAN for at least 3 months prior to Screening. Approximately 450 participants will be randomized in a 1:1 allocation ratio to receive a weight-based IV infusion of either ravulizumab or placebo. An interim analysis may be conducted at Week 34 to evaluate change in proteinuria and the final analysis will be conducted at Week 106 to evaluate eGFR. In addition, approximately 60 participants with eGFR 20-29 mL/min/1.73m2 will be enrolled in an Advanced Kidney Disease (AdKD) Cohort. After Week 106, all participants have the option to enter an Open-label Ravulizumab Access Period.

Conditions: Immunoglobulin A Nephropathy, IgAN
Being tested: Ravulizumab, Placebo
Keywords: Immunoglobulin A nephropathy, IgAN, proteinuria, glomerulonephropathy, chronic kidney disease, CKD
Medical subject headings: Glomerulonephritis, IGA, Proteinuria, Renal Insufficiency, Chronic

What participants receive

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

RavulizumabDrug
Participants will receive ravulizumab via weight-based intravenous (IV) infusion.
PlaceboDrug
Participants will receive placebo via weight-based IV infusion.

Study groups in NCT06291376
Study group	Role	What they receive
Ravulizumab IV q8w	Experimental	Participants will receive a weight-based loading dose on Day 1 followed by weight-based maintenance dosing initiated on Day 15, and then administered every 8 weeks (q8w). Receives: Drug: Ravulizumab
Placebo IV q8w	Placebo comparator	Participants will receive a weight-based loading dose on Day 1 followed by weight-based maintenance dosing initiated on Day 15, and then administered q8w. Receives: Drug: Placebo

What is being measured

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

Change from Baseline in Proteinuria Based on 24-hour Urine Protein Creatinine Ratio (UPCR) at Week 34
Evaluated at interim analysis only
Measured: Baseline, Week 34
Change from Baseline in Glomerular Filtration Rate (eGFR) at Week 106
Evaluated at final analysis only
Measured: Baseline, Week 106

Secondary outcomes (14)

Change from Baseline in Proteinuria Based on 24-hour Urine Protein Creatinine Ratio (UPCR) at Weeks 10, 26, 34, 50, and 106
Evaluated at interim and final analysis
Measured: Baseline, Weeks 10, 26, 34, 50, and 106
Change From Baseline in eGFR at Weeks 34 and 50
Evaluated at interim and final analysis
Measured: Baseline, Weeks 34 and 50
Change From Baseline in Albuminuria at Each Scheduled Visit Up to Week 106
Evaluated at interim and final analysis
Measured: Baseline, at Each Scheduled Visit Up to Week 106
Reduction in 24-hour UPCR ≥ 50% From Baseline at Each Scheduled Visit Up to Week 106
Evaluated at interim and final analysis
Measured: Baseline, at Each Scheduled Visit Up to Week 106
Number of Participants With Partial Remission at Each Scheduled Visit Up to Week 106
Evaluated at interim and final analysis
Measured: Baseline, at Each Scheduled Visit Up to Week 106
Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Weeks 34, 50, and 106
Evaluated at interim and final analysis
Measured: Baseline, Weeks 34, 50, and 106
Annualized eGFR Slope Over 50 Weeks
Evaluated at interim analysis only
Measured: Baseline, Over 50 Weeks
Change from Baseline in Proteinuria Based on 24-hour UPCR at Week 34 with baseline UPCR ≥ 1.5 g/g
Evaluated at final analysis only
Measured: Baseline Up to Week 34
Change from Baseline in Proteinuria Based on 24-hour UPCR at Week 34 in Participants with Baseline UPCR ≥ 1.5 g/g and Presence of Hematuria at Baseline
Evaluated at final analysis only
Measured: Baseline Up to Week 34
Change from Baseline in eGFR at Week 106 in Participants with Baseline UPCR ≥ 1.5 g/g
Evaluated at final analysis only
Measured: Baseline Up to Week 106
Time to Sustained ≥ 30% eGFR Decline Up to Week 106
Evaluated at final analysis only
Measured: Baseline Up to Week 106
Time to Sustained eGFR Decline ≥ 40% Up to Week 106
Evaluated at final analysis only
Measured: Baseline Up to Week 106
Time to First Composite Kidney Event Up to Week 106
Composite kidney event endpoint is defined as reaching at least 1 of the following: Sustained ≥ 30% decline in eGFR relative to baseline; or Sustained eGFR < 15 milliliter (mL)/minute (min)/1.73 square meter (m^2); or Maintenance dialysis; or Receipt of kidney transplant; or Death from kidney failure.
Evaluated at final analysis only
Measured: Baseline Up to Week 106
Use of Alternative IgAN Therapy Up to Week 106
Evaluated at final analysis only
Measured: Baseline, Up to Week 106

Timeline

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

29 Mar 202418 Jul 2030

First posted4 Mar 2024
Study start29 Mar 2024
Primary completion5 Jan 2026
Study completion18 Jul 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Immunoglobulin A NephropathyStudies of the same condition, open and under way.
More trials run by Alexion Pharmaceuticals, Inc.The 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
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 584 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06291376
Sponsor's protocol ID: D928FC00001
Acronym: I CAN
Status last verified: Sep 2026
First submitted: 26 Feb 2024
Last updated: 2 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

Publications

Barratt J, Farag YMK, Rice K, Cammett TJ, Inker LA, Trimarchi H, Bruchfeld A, Heerspink HJL, Liew A, Carroll K, Zhang H, Norouzi S, Hou S, Park S, Perez Valdivia MA, Radhakrishnan J, Suzuki Y, Schneider B, Marsala J, Carrillo-Infante C, Lake SL, Singh AK, Nolan S, Lafayette RA; I CAN Trial Group. Ravulizumab in IgA Nephropathy - Interim Analysis of a Phase 3 Trial. N Engl J Med. 2026 Oct 23. doi: 10.1056/NEJMoa2607544. Online ahead of print.
PubMed 42912700
Lafayette R, Tumlin J, Fenoglio R, Kaufeld J, Perez Valdivia MA, Wu MS, Susan Huang SH, Alamartine E, Kim SG, Yee M, Kateifides A, Rice K, Garlo K, Barratt J; SANCTUARY Study Investigators. Efficacy and Safety of Ravulizumab in IgA Nephropathy: A Phase 2 Randomized Double-Blind Placebo-Controlled Trial. J Am Soc Nephrol. 2025 Apr 1;36(4):645-656. doi: 10.1681/ASN.0000000534. Epub 2024 Oct 25.
PubMed 39455063

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

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 locations

RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 3
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
Glomerulonephritis
RecruitingPhase 2
A Study of Clazakizumab (LY5724886) in Adults With Elevated hsCRP and at Increased Risk for Cardiovascular Event
Atherosclerosis, Cardiovascular Disease

All Immunoglobulin A Nephropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Immunoglobulin A Nephropathy (IgAN)
ClinicalTrials.gov ID: NCT06291376
Acronym / sponsor ID: I CAN / D928FC00001
Conditions: Immunoglobulin A Nephropathy, IgAN
Keywords: Immunoglobulin A nephropathy, IgAN, proteinuria, glomerulonephropathy, chronic kidney disease, CKD
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 584 participants (actual)
Lead sponsor: Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 29 Mar 2024 (actual)
Primary completion: 5 Jan 2026 (actual)
Study completion: 18 Jul 2030 (estimated)
First posted: 4 Mar 2024 (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.

Detailed description

Study design

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

Arm	Type	Receives
Ravulizumab IV q8w	Experimental	Drug: RavulizumabParticipants will receive a weight-based loading dose on Day 1 followed by weight-based maintenance dosing initiated on Day 15, and then administered every 8 weeks (q8w).
Placebo IV q8w	Placebo comparator	Drug: PlaceboParticipants will receive a weight-based loading dose on Day 1 followed by weight-based maintenance dosing initiated on Day 15, and then administered q8w.

Who may qualify

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

Key inclusion criteria (6 listed)

Documentation of IgAN diagnosis established on kidney biopsy obtained any time prior to or during the Screening Period for participants with eGFR ≥ 30 mL/min/1.73 m^2.
For participants in the AdKD cohorts, eGFR 20 to 29 mL/min/1.73 m2 a kidney biopsy is required within 6 months prior to Screening or during the Screening Period.
UPCR ≥ 0.75 g/g or UP ≥1 g/day calculated from the mean of two 24-hour urine during the Screening Period.
Estimated GFR ≥ 30 mL/min/1.73 m2 at Screening.
Stable and maximum allowed or tolerated RAASI (ACEI and/or ARB) dose for ≥ 3 months prior to Screening with no planned change during Screening through Week 106.

Key exclusion criteria (10 listed)

Diagnosis of rapid progressive glomerulonephritis as measured by eGFR loss ≥ 50% over a period of 3 months prior to Screening.
Secondary IgAN (eg, due to systemic lupus erythematosus (SLE), cirrhosis, or celiac disease; IgAV-N may be eligible).
Concomitant clinically significant renal disease other than IgAN.
Prior use of immunosuppressive treatment within 3 months of screening.
Uncontrolled diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8.5%.

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
RavulizumabParticipants will receive ravulizumab via weight-based intravenous (IV) infusion.	Drug	Ravulizumab IV q8w
PlaceboParticipants will receive placebo via weight-based IV infusion.	Drug	Placebo IV q8w

Primary outcome

Change from Baseline in Proteinuria Based on 24-hour Urine Protein Creatinine Ratio (UPCR) at Week 34
Time frame: Baseline, Week 34
Evaluated at interim analysis only
Change from Baseline in Glomerular Filtration Rate (eGFR) at Week 106
Time frame: Baseline, Week 106
Evaluated at final analysis only

14 secondary outcomes

Change from Baseline in Proteinuria Based on 24-hour Urine Protein Creatinine Ratio (UPCR) at Weeks 10, 26, 34, 50, and 106
Time frame: Baseline, Weeks 10, 26, 34, 50, and 106
Change From Baseline in eGFR at Weeks 34 and 50
Time frame: Baseline, Weeks 34 and 50
Change From Baseline in Albuminuria at Each Scheduled Visit Up to Week 106
Time frame: Baseline, at Each Scheduled Visit Up to Week 106
Reduction in 24-hour UPCR ≥ 50% From Baseline at Each Scheduled Visit Up to Week 106
Time frame: Baseline, at Each Scheduled Visit Up to Week 106
Number of Participants With Partial Remission at Each Scheduled Visit Up to Week 106
Time frame: Baseline, at Each Scheduled Visit Up to Week 106
Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Weeks 34, 50, and 106
Time frame: Baseline, Weeks 34, 50, and 106
Annualized eGFR Slope Over 50 Weeks
Time frame: Baseline, Over 50 Weeks
Change from Baseline in Proteinuria Based on 24-hour UPCR at Week 34 with baseline UPCR ≥ 1.5 g/g
Time frame: Baseline Up to Week 34
Change from Baseline in Proteinuria Based on 24-hour UPCR at Week 34 in Participants with Baseline UPCR ≥ 1.5 g/g and Presence of Hematuria at Baseline
Time frame: Baseline Up to Week 34
Change from Baseline in eGFR at Week 106 in Participants with Baseline UPCR ≥ 1.5 g/g
Time frame: Baseline Up to Week 106
Time to Sustained ≥ 30% eGFR Decline Up to Week 106
Time frame: Baseline Up to Week 106
Time to Sustained eGFR Decline ≥ 40% Up to Week 106
Time frame: Baseline Up to Week 106
Time to First Composite Kidney Event Up to Week 106
Time frame: Baseline Up to Week 106
Use of Alternative IgAN Therapy Up to Week 106
Time frame: Baseline, Up to Week 106

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 2 Oct 2026.
Derived from this study: PubMed 42912700Barratt J, Farag YMK, Rice K, Cammett TJ, Inker LA, Trimarchi H, Bruchfeld A, Heerspink HJL, Liew A, Carroll K, Zhang H, Norouzi S, Hou S, Park S, Perez Valdivia MA, Radhakrishnan J, Suzuki Y, Schneider B, Marsala J, Carrillo-Infante C, Lake SL, Singh AK, Nolan S, Lafayette RA; I CAN Trial Group. Ravulizumab in IgA Nephropathy - Interim Analysis of a Phase 3 Trial. N Engl J Med. 2026 Oct 23. doi: 10.1056/NEJMoa2607544. Online ahead of print.
Derived from this study: PubMed 39455063Lafayette R, Tumlin J, Fenoglio R, Kaufeld J, Perez Valdivia MA, Wu MS, Susan Huang SH, Alamartine E, Kim SG, Yee M, Kateifides A, Rice K, Garlo K, Barratt J; SANCTUARY Study Investigators. Efficacy and Safety of Ravulizumab in IgA Nephropathy: A Phase 2 Randomized Double-Blind Placebo-Controlled Trial. J Am Soc Nephrol. 2025 Apr 1;36(4):645-656. doi: 10.1681/ASN.0000000534. Epub 2024 Oct 25.
Individual participant dataSharing planned: Yes. Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

246 sites in 28 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ravulizumab in people with Immunoglobulin A Nephropathy and IgAN, run by Alexion Pharmaceuticals, Inc. at 246 sites in 28 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 10 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: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 246 sites in United States, China, Japan, France, Italy and 23 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 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?

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?

Change from Baseline in Proteinuria Based on 24-hour Urine Protein Creatinine Ratio (UPCR) at Week 34 (time frame: Baseline, Week 34). 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 NCT06291376, which also lists 2 linked publications.

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 2 Oct 2026.