Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)
I CAN
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)
1 other identifier
interventional
579
27 countries
243
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2024
Longer than P75 for phase_3
243 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2024
CompletedFirst Posted
Study publicly available on registry
March 4, 2024
CompletedStudy Start
First participant enrolled
March 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 19, 2030
ExpectedJune 22, 2026
June 1, 2026
1.8 years
February 26, 2024
June 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from Baseline in Proteinuria Based on 24-hour Urine Protein Creatinine Ratio (UPCR) at Week 34
Evaluated at interim analysis only
Baseline, Week 34
Change from Baseline in Glomerular Filtration Rate (eGFR) at Week 106
Evaluated at final analysis only
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
Baseline, Weeks 10, 26, 34, 50, and 106
Change From Baseline in eGFR at Weeks 34 and 50
Baseline, Weeks 34 and 50
Change From Baseline in Albuminuria at Each Scheduled Visit Up to Week 106
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
Baseline, at Each Scheduled Visit Up to Week 106
Number of Participants With Partial Remission at Each Scheduled Visit Up to Week 106
Baseline, at Each Scheduled Visit Up to Week 106
- +9 more secondary outcomes
Study Arms (2)
Ravulizumab IV q8w
EXPERIMENTALParticipants 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 COMPARATORParticipants will receive a weight-based loading dose on Day 1 followed by weight-based maintenance dosing initiated on Day 15, and then administered q8w.
Interventions
Participants will receive ravulizumab via weight-based intravenous (IV) infusion.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (246)
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Alabaster, Alabama, 35007, United States
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Phoenix, Arizona, 85054, United States
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Los Angeles, California, 90022, United States
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Los Angeles, California, 90027, United States
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Los Angeles, California, 90095, United States
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Orange, California, 92868, United States
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San Bernardino, California, 92408, United States
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San Diego, California, 92120, United States
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San Francisco, California, 94143, United States
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Stanford, California, 94305, United States
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Torrance, California, 90502, United States
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Valencia, California, 91355, United States
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Bay Pines, Florida, 33744, United States
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Miami, Florida, 33136, United States
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Orlando, Florida, 32806, United States
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Acworth, Georgia, 30101, United States
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Atlanta, Georgia, 30322, United States
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Lawrenceville, Georgia, 30046, United States
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New Orleans, Louisiana, 70121, United States
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Boston, Massachusetts, 02111, United States
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Boston, Massachusetts, 02114, United States
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Boston, Massachusetts, 02115, United States
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Worcester, Massachusetts, 01655, United States
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Minneapolis, Minnesota, 55435, United States
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Minneapolis, Minnesota, 55455, United States
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Kansas City, Missouri, 64111, United States
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North Las Vegas, Nevada, 89086, United States
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Albany, New York, 12208, United States
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New York, New York, 10016, United States
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The Bronx, New York, 10468, United States
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Columbus, Ohio, 43210, United States
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Knoxville, Tennessee, 37920, United States
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Arlington, Texas, 76002, United States
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Houston, Texas, 77030, United States
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Houston, Texas, 77054, United States
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San Antonio, Texas, 78229, United States
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Shenandoah, Texas, 77384, United States
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Charlottesville, Virginia, 22908, United States
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Milwaukee, Wisconsin, 53226, United States
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Ciudad de Buenos Aires, C1015ABO, Argentina
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Ciudad de Buenos Aires, C1425AGC, Argentina
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Córdoba, X5016KET, Argentina
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La Plata, B1902COS, Argentina
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Rosario, 2000, Argentina
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Canberra, 2605, Australia
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Clayton, 3168, Australia
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Concord, 2139, Australia
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Herston, 4029, Australia
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Liverpool, 2170, Australia
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Perth, 6000, Australia
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Southport, 4222, Australia
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St Albans, 3021, Australia
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Linz, 4020, Austria
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Brussels, 1090, Belgium
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Edegem, 2650, Belgium
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Leuven, 3000, Belgium
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Belo Horizonte, 30110-934, Brazil
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Belo Horizonte, 30150-221, Brazil
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Botucatu, 18618-687, Brazil
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Curitiba, 80440-020, Brazil
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Fortaleza, 60430-270, Brazil
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Recife, 50670-901, Brazil
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Ribeirão Preto, 14051-140, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 04038-002, Brazil
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São Paulo, 05403-000, Brazil
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Winnipeg, Manitoba, R2V 3M3, Canada
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Brampton, Ontario, L6T 5T6, Canada
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London, Ontario, N6A 5W9, Canada
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Toronto, Ontario, M5G 2C4, Canada
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Araucania, 4781151, Chile
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Providencia, 7500000, Chile
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Santiago, 7500922, Chile
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Santiago, 8330034, Chile
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Valdivia, 5090146, Chile
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Baotou, 14010, China
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Beijing, 100029, China
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Beijing, 100034, China
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Beijing, 100044, China
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Changsha, 410013, China
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Changzhou, 272100, China
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Chengdu, 610000, China
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Chengdu, 610072, China
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Chongqing, 400010, China
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Guangzhou, 510100, China
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Hangzhou, 310003, China
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Jinan, 250021, China
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Jinhua, 321000, China
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Lanzhou, 730000, China
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Luoyang, 471000, China
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Nanchang, 330006, China
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Nanchang, 330008, China
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Nanjing, 210009, China
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Nanjing, 210011, China
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Nanjing, 210029, China
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Ningbo, 315010, China
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Qingdao, 110016, China
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Shanghai, 200025, China
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Shanghai, 200040, China
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Shanghai, 200065, China
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Shenzhen, 518036, China
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Shenzhen, 518053, China
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Ürümqi, 831118, China
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Wuhan, 430060, China
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Wuxi, 214023, China
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Xi'an, 710061, China
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Yantai, 264000, China
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Yibin, 610500, China
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Yinchuan, 750004, China
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Zhengzhou, 450052, China
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Nový Jičín, 741 01, Czechia
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Prague, 128 00, Czechia
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Prague, 140 00, Czechia
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Amiens, 80054, France
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Bayonne, 64100, France
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Brest, 29200, France
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Chambéry, 73011, France
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Le Kremlin-Bicêtre, 94270, France
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Marseille, 13385, France
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Nantes, 44093, France
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Paris, 75010, France
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Paris, 75015, France
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Saint-Priest-en-Jarez, 42270, France
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Strasbourg, 67091, France
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Toulouse, 31059, France
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Aachen, 52074, Germany
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Berlin, 10117, Germany
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Erlangen, 91054, Germany
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Essen, 45122, Germany
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Greifswald, 17475, Germany
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Hanover, 30625, Germany
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Mainz, 55131, Germany
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München, 81377, Germany
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München, 81657, Germany
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Villingen-Schwenningen, 78052, Germany
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Athens, 11527, Greece
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Athens, 12462, Greece
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Heraklion, 71500, Greece
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Thessaloniki, 57010, Greece
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Hong Kong, 999077, Hong Kong
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Hong Kong, Hong Kong
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Haifa, 3109601, Israel
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Jerusalem, 91120, Israel
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Nazareth, 16100, Israel
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Petah Tikva, 49372, Israel
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Tel Aviv, 6423906, Israel
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Agrigento, 92100, Italy
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Bologna, 40138, Italy
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Brescia, 25123, Italy
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Cagliari, 09121, Italy
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Florence, 50134, Italy
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Milan, 20122, Italy
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Milan, 20132, Italy
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Padova, 35128, Italy
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Parma, 43126, Italy
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Torino, 10154, Italy
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Torrette, 60126, Italy
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Verona, 37126, Italy
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Bunkyō City, 113-8431, Japan
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Chiba, 260-8677, Japan
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Chiba, 260-8712, Japan
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Fukuoka, 815-8555, Japan
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Kamakura, 247-8533, Japan
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Kasugai-shi, 486-8510, Japan
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Kitakyushu-shi, 802-8555, Japan
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Kobe, 650-0047, Japan
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Matsumoto-shi, 390-8621, Japan
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Matsuyama, 790-8524, Japan
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Nagoya, 466-8650, Japan
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Osaka, 534-0021, Japan
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Osaka, 545-8586, Japan
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Sapporo, 060-8604, Japan
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Urayasu-shi, 279-0021, Japan
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Ipoh, 30990, Malaysia
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Johor Bahru, 80100, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Seremban, 70300, Malaysia
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Amsterdam, 1105 AZ, Netherlands
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Rotterdam, 3045 PM, Netherlands
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Bialystok, 15-276, Poland
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Bialystok, 15-540, Poland
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Krakow, 31-513, Poland
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Lodz, 92-213, Poland
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Lublin, 20-090, Poland
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Olsztyn, 10-561, Poland
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Poznan, 60-355, Poland
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Szczecin, 70-111, Poland
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Warsaw, 02-006, Poland
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Warsaw, 02-507, Poland
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Dammam, 31444, Saudi Arabia
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Jeddah, 21499, Saudi Arabia
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Riyadh, 11211, Saudi Arabia
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Riyadh, 12231, Saudi Arabia
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Banská Bystrica, 974 01, Slovakia
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Martin, 03659, Slovakia
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Anyang-si, 14068, South Korea
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Busan, 49241, South Korea
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Deagu, 41944, South Korea
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Gwangju, 61469, South Korea
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Gyeonggi-do, 13620, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05278, South Korea
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Suwon, 16499, South Korea
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A Coruña, 15006, Spain
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Alcalá de Henares, 28805, Spain
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Lleida, 25198, Spain
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Madrid, 28031, Spain
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Madrid, 28040, Spain
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Málaga, 29010, Spain
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Murcia, 30120, Spain
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Oviedo, 33011, Spain
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Seville, 41013, Spain
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Tarragona, 09-43005, Spain
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Zaragoza, 50009, Spain
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Kaohsiung City, 80756, Taiwan
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Kaohsiung City, 81362, Taiwan
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Kaohsiung City, 833401, Taiwan
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New Taipei City, 220, Taiwan
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New Taipei City, 23561, Taiwan
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Taichung, 40705, Taiwan
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Taichung, Taiwan
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Tainan, 70403, Taiwan
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Taipei, 10002, Taiwan
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Taoyuan, 333, Taiwan
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Chiang Mai, 50200, Thailand
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Khon Kaen, 40002, Thailand
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Ankara, 06560, Turkey (Türkiye)
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Bursa, 16059, Turkey (Türkiye)
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Istanbul, 34098, Turkey (Türkiye)
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Istanbul, 34452, Turkey (Türkiye)
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Kayseri, 38039, Turkey (Türkiye)
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Kocaeli, 41380, Turkey (Türkiye)
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Konya, 42080, Turkey (Türkiye)
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Cambridge, CB2 0QQ, United Kingdom
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Doncaster, DN2 5LT, United Kingdom
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Leicester, Le5 4PW, United Kingdom
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London, E1 1BB, United Kingdom
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Manchester, M13 9WL, United Kingdom
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Reading, RG1 5AN, United Kingdom
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Stevenage, SG1 4AB, United Kingdom
Related Publications (1)
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.
PMID: 39455063DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2024
First Posted
March 4, 2024
Study Start
March 29, 2024
Primary Completion
January 5, 2026
Study Completion (Estimated)
July 19, 2030
Last Updated
June 22, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.