New drug aims to slow kidney disease in IgA nephropathy patients

NCT ID NCT06291376

Disease control Sponsor: Alexion Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests ravulizumab, a drug that blocks part of the immune system, against a placebo in 579 adults with IgA nephropathy—a kidney disease that can lead to kidney failure. The goal is to see if ravulizumab reduces protein in the urine and preserves kidney function over about two years. Participants must have a confirmed diagnosis and signs of active disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: ravulizumab
What this could lead to: If it works, this could provide a new treatment option to slow kidney damage and delay the need for dialysis or transplant in people with IgA nephropathy.
What could go wrong: This is a large phase 3 trial, but ravulizumab is not a cure—patients may still need ongoing care. It also carries risks like increased susceptibility to certain infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

579 people

The number who actually took part.

Started

Mar 2024

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

chronic renal failure syndrome IgA glomerulonephritis IgA nephropathy, susceptibility to, 1 proteinuria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

IGAN Immunoglobulin A nephropathy

Contacts and locations

Locations

Research Site

Alabaster, Alabama, 35007, United States
Research Site

Phoenix, Arizona, 85054, United States
Research Site

Los Angeles, California, 90022, United States
Research Site

Los Angeles, California, 90027, United States
Research Site

Los Angeles, California, 90095, United States
Research Site

Orange, California, 92868, United States
Research Site

San Bernardino, California, 92408, United States
Research Site

San Diego, California, 92120, United States
Research Site

San Francisco, California, 94143, United States
Research Site

Stanford, California, 94305, United States
Research Site

Torrance, California, 90502, United States
Research Site

Valencia, California, 91355, United States
Research Site

Bay Pines, Florida, 33744, United States
Research Site

Miami, Florida, 33136, United States
Research Site

Orlando, Florida, 32806, United States
Research Site

Acworth, Georgia, 30101, United States
Research Site

Atlanta, Georgia, 30322, United States
Research Site

Lawrenceville, Georgia, 30046, United States
Research Site

New Orleans, Louisiana, 70121, United States
Research Site

Boston, Massachusetts, 02111, United States
Research Site

Boston, Massachusetts, 02114, United States
Research Site

Boston, Massachusetts, 02115, United States
Research Site

Worcester, Massachusetts, 01655, United States
Research Site

Minneapolis, Minnesota, 55435, United States
Research Site

Minneapolis, Minnesota, 55455, United States
Research Site

Kansas City, Missouri, 64111, United States
Research Site

North Las Vegas, Nevada, 89086, United States
Research Site

Albany, New York, 12208, United States
Research Site

New York, New York, 10016, United States
Research Site

The Bronx, New York, 10468, United States
Research Site

Columbus, Ohio, 43210, United States
Research Site

Knoxville, Tennessee, 37920, United States
Research Site

Arlington, Texas, 76002, United States
Research Site

Houston, Texas, 77030, United States
Research Site

Houston, Texas, 77054, United States
Research Site

San Antonio, Texas, 78229, United States
Research Site

Shenandoah, Texas, 77384, United States
Research Site

Charlottesville, Virginia, 22908, United States
Research Site

Milwaukee, Wisconsin, 53226, United States
Research Site

Ciudad de Buenos Aires, C1015ABO, Argentina
Research Site

Ciudad de Buenos Aires, C1425AGC, Argentina
Research Site

Córdoba, X5016KET, Argentina
Research Site

La Plata, B1902COS, Argentina
Research Site

Rosario, 2000, Argentina
Research Site

Canberra, 2605, Australia
Research Site

Clayton, 3168, Australia
Research Site

Concord, 2139, Australia
Research Site

Herston, 4029, Australia
Research Site

Liverpool, 2170, Australia
Research Site

Perth, 6000, Australia
Research Site

Southport, 4222, Australia
Research Site

St Albans, 3021, Australia
Research Site

Graz, 8036, Austria
Research Site

Innsbruck, 6020, Austria
Research Site

Linz, 4020, Austria
Research Site

Brussels, 1090, Belgium
Research Site

Edegem, 2650, Belgium
Research Site

Leuven, 3000, Belgium
Research Site

Belo Horizonte, 30110-934, Brazil
Research Site

Belo Horizonte, 30150-221, Brazil
Research Site

Botucatu, 18618-687, Brazil
Research Site

Curitiba, 80440-020, Brazil
Research Site

Fortaleza, 60430-270, Brazil
Research Site

Recife, 50670-901, Brazil
Research Site

Ribeirão Preto, 14051-140, Brazil
Research Site

São José do Rio Preto, 15090-000, Brazil
Research Site

São Paulo, 04038-002, Brazil
Research Site

São Paulo, 05403-000, Brazil
Research Site

Winnipeg, Manitoba, R2V 3M3, Canada
Research Site

Brampton, Ontario, L6T 5T6, Canada
Research Site

London, Ontario, N6A 5W9, Canada
Research Site

Toronto, Ontario, M5G 2C4, Canada
Research Site

Araucania, 4781151, Chile
Research Site

Providencia, 7500000, Chile
Research Site

Santiago, 7500922, Chile
Research Site

Santiago, 8330034, Chile
Research Site

Valdivia, 5090146, Chile
Research Site

Baotou, 14010, China
Research Site

Beijing, 100029, China
Research Site

Beijing, 100034, China
Research Site

Beijing, 100044, China
Research Site

Changsha, 410013, China
Research Site

Changzhou, 272100, China
Research Site

Chengdu, 610000, China
Research Site

Chengdu, 610072, China
Research Site

Chongqing, 400010, China
Research Site

Guangzhou, 510100, China
Research Site

Hangzhou, 310003, China
Research Site

Jinan, 250021, China
Research Site

Jinhua, 321000, China
Research Site

Lanzhou, 730000, China
Research Site

Luoyang, 471000, China
Research Site

Nanchang, 330006, China
Research Site

Nanchang, 330008, China
Research Site

Nanjing, 210009, China
Research Site

Nanjing, 210011, China
Research Site

Nanjing, 210029, China
Research Site

Ningbo, 315010, China
Research Site

Qingdao, 110016, China
Research Site

Shanghai, 200025, China
Research Site

Shanghai, 200040, China
Research Site

Shanghai, 200065, China
Research Site

Shenzhen, 518036, China
Research Site

Shenzhen, 518053, China
Research Site

Ürümqi, 831118, China
Research Site

Wuhan, 430060, China
Research Site

Wuxi, 214023, China
Research Site

Xi'an, 710061, China
Research Site

Yantai, 264000, China
Research Site

Yibin, 610500, China
Research Site

Yinchuan, 750004, China
Research Site

Zhengzhou, 450052, China
Research Site

Nový Jičín, 741 01, Czechia
Research Site

Prague, 128 00, Czechia
Research Site

Prague, 140 00, Czechia
Research Site

Amiens, 80054, France
Research Site

Bayonne, 64100, France
Research Site

Brest, 29200, France
Research Site

Chambéry, 73011, France
Research Site

Le Kremlin-Bicêtre, 94270, France
Research Site

Marseille, 13385, France
Research Site

Nantes, 44093, France
Research Site

Paris, 75010, France
Research Site

Paris, 75015, France
Research Site

Saint-Priest-en-Jarez, 42270, France
Research Site

Strasbourg, 67091, France
Research Site

Toulouse, 31059, France
Research Site

Aachen, 52074, Germany
Research Site

Berlin, 10117, Germany
Research Site

Erlangen, 91054, Germany
Research Site

Essen, 45122, Germany
Research Site

Greifswald, 17475, Germany
Research Site

Hanover, 30625, Germany
Research Site

Mainz, 55131, Germany
Research Site

München, 81377, Germany
Research Site

München, 81657, Germany
Research Site

Villingen-Schwenningen, 78052, Germany
Research Site

Athens, 11527, Greece
Research Site

Athens, 12462, Greece
Research Site

Heraklion, 71500, Greece
Research Site

Thessaloniki, 57010, Greece
Research Site

Hong Kong, 999077, Hong Kong
Research Site

Hong Kong, Hong Kong
Research Site

Haifa, 3109601, Israel
Research Site

Jerusalem, 91120, Israel
Research Site

Nazareth, 16100, Israel
Research Site

Petah Tikva, 49372, Israel
Research Site

Tel Aviv, 6423906, Israel
Research Site

Agrigento, 92100, Italy
Research Site

Bologna, 40138, Italy
Research Site

Brescia, 25123, Italy
Research Site

Cagliari, 09121, Italy
Research Site

Florence, 50134, Italy
Research Site

Milan, 20122, Italy
Research Site

Milan, 20132, Italy
Research Site

Padova, 35128, Italy
Research Site

Parma, 43126, Italy
Research Site

Torino, 10154, Italy
Research Site

Torrette, 60126, Italy
Research Site

Verona, 37126, Italy
Research Site

Bunkyō City, 113-8431, Japan
Research Site

Chiba, 260-8677, Japan
Research Site

Chiba, 260-8712, Japan
Research Site

Fukuoka, 815-8555, Japan
Research Site

Kamakura, 247-8533, Japan
Research Site

Kasugai-shi, 486-8510, Japan
Research Site

Kitakyushu-shi, 802-8555, Japan
Research Site

Kobe, 650-0047, Japan
Research Site

Matsumoto-shi, 390-8621, Japan
Research Site

Matsuyama, 790-8524, Japan
Research Site

Nagoya, 466-8650, Japan
Research Site

Osaka, 534-0021, Japan
Research Site

Osaka, 545-8586, Japan
Research Site

Sapporo, 060-8604, Japan
Research Site

Urayasu-shi, 279-0021, Japan
Research Site

Ipoh, 30990, Malaysia
Research Site

Johor Bahru, 80100, Malaysia
Research Site

Kuala Lumpur, 59100, Malaysia
Research Site

Seremban, 70300, Malaysia
Research Site

Amsterdam, 1105 AZ, Netherlands
Research Site

Rotterdam, 3045 PM, Netherlands
Research Site

Bialystok, 15-276, Poland
Research Site

Bialystok, 15-540, Poland
Research Site

Krakow, 31-513, Poland
Research Site

Lodz, 92-213, Poland
Research Site

Lublin, 20-090, Poland
Research Site

Olsztyn, 10-561, Poland
Research Site

Poznan, 60-355, Poland
Research Site

Szczecin, 70-111, Poland
Research Site

Warsaw, 02-006, Poland
Research Site

Warsaw, 02-507, Poland
Research Site

Dammam, 31444, Saudi Arabia
Research Site

Jeddah, 21499, Saudi Arabia
Research Site

Riyadh, 11211, Saudi Arabia
Research Site

Riyadh, 12231, Saudi Arabia
Research Site

Banská Bystrica, 974 01, Slovakia
Research Site

Martin, 03659, Slovakia
Research Site

Anyang-si, 14068, South Korea
Research Site

Busan, 49241, South Korea
Research Site

Deagu, 41944, South Korea
Research Site

Gwangju, 61469, South Korea
Research Site

Gyeonggi-do, 13620, South Korea
Research Site

Seoul, 03080, South Korea
Research Site

Seoul, 03722, South Korea
Research Site

Seoul, 05278, South Korea
Research Site

Suwon, 16499, South Korea
Research Site

A Coruña, 15006, Spain
Research Site

Alcalá de Henares, 28805, Spain
Research Site

Lleida, 25198, Spain
Research Site

Madrid, 28031, Spain
Research Site

Madrid, 28040, Spain
Research Site

Málaga, 29010, Spain
Research Site

Murcia, 30120, Spain
Research Site

Oviedo, 33011, Spain
Research Site

Seville, 41013, Spain
Research Site

Tarragona, 09-43005, Spain
Research Site

Zaragoza, 50009, Spain
Research Site

Kaohsiung City, 80756, Taiwan
Research Site

Kaohsiung City, 81362, Taiwan
Research Site

Kaohsiung City, 833401, Taiwan
Research Site

New Taipei City, 220, Taiwan
Research Site

New Taipei City, 23561, Taiwan
Research Site

Taichung, 40705, Taiwan
Research Site

Taichung, Taiwan
Research Site

Tainan, 70403, Taiwan
Research Site

Taipei, 10002, Taiwan
Research Site

Taoyuan, 333, Taiwan
Research Site

Bangkok, 10330, Thailand
Research Site

Bangkok, 10400, Thailand
Research Site

Bangkok, 10700, Thailand
Research Site

Chiang Mai, 50200, Thailand
Research Site

Khon Kaen, 40002, Thailand
Research Site

Ankara, 06560, Turkey (Türkiye)
Research Site

Bursa, 16059, Turkey (Türkiye)
Research Site

Istanbul, 34098, Turkey (Türkiye)
Research Site

Istanbul, 34452, Turkey (Türkiye)
Research Site

Kayseri, 38039, Turkey (Türkiye)
Research Site

Kocaeli, 41380, Turkey (Türkiye)
Research Site

Konya, 42080, Turkey (Türkiye)
Research Site

Cambridge, CB2 0QQ, United Kingdom
Research Site

Doncaster, DN2 5LT, United Kingdom
Research Site

Leicester, Le5 4PW, United Kingdom
Research Site

London, E1 1BB, United Kingdom
Research Site

Manchester, M13 9WL, United Kingdom
Research Site

Reading, RG1 5AN, United Kingdom
Research Site

Stevenage, SG1 4AB, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.