Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

NCT06291376 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: D928FC00001
• Study Type: interventional
• Target: 510
• Locations: 27 countries
• Sites: 264

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.

Conditions

Immunoglobulin A Nephropathy; IgAN

Keywords

Immunoglobulin A nephropathy; IgAN; proteinuria; glomerulonephropathy; chronic kidney disease; CKD

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 (11)

• 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

Study Arms (2)

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).

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.

Drug: Placebo

Interventions

Ravulizumab DRUG

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

Ravulizumab IV q8w

Placebo DRUG

Participants will receive placebo via weight-based IV infusion.

Placebo IV q8w

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 RASI (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.

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead

Study Sites (267)

Research Site

Alabaster, Alabama, 35007, United States

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Phoenix, Arizona, 85054, United States

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Loma Linda, California, 92354, 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 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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Aurora, Colorado, 80045, 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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Iowa City, Iowa, 52242, United States

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New Orleans, Louisiana, 70121, United States

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Shreveport, Louisiana, 71103, United States

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Augusta, Maine, 04330, 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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East Setauket, New York, 11733, 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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Charleston, South Carolina, 29425, 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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Temple, Texas, 76508, 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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San Juan Bautista, 1888, Argentina

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Camperdown, 2050, Australia

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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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Parkville, 3050, 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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Zhongshan, 528401, 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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Cologne, 50937, 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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Konstanz, 78464, 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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Pátrai, 26504, 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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Taiping, 34000, 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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Madrid, 28046, Spain

WITHDRAWN

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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 District, 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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Kahramanmaraş, 46100, 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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Pamukkale, 20070, Turkey (Türkiye)

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Cambridge, CB2 0QQ, United Kingdom

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Doncaster, DN2 5LT, United Kingdom

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Dundee, DD1 9SY, United Kingdom

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Leicester, Le5 4PW, United Kingdom

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London, E1 1BB, United Kingdom

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London, SE1 9RT, United Kingdom

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Manchester, M13 9WL, United Kingdom

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Reading, RG1 5AN, United Kingdom

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Salford, M6 8HD, United Kingdom

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Stevenage, SG1 4AB, United Kingdom

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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: 39455063 DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGA; Proteinuria; Renal Insufficiency, Chronic

Interventions

ravulizumab

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes

Central Study Contacts

Alexion Pharmaceuticals, Inc. (Sponsor)

CONTACT

1-855-752-2356; clinicaltrials@alexion.com

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: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

CA (4); BR (10); DE (12); SL (2); US (46); BE (3); HK (2); IL (5); SA (4); FR (12); AR (6); CL (5); ES (12); JP (15); IT (12); KR (9); NL (2); CZ (3); AU (10); GR (5); TW (10); TU (9); MY (5); GB (10); PL (10); TH (5); CN (36)