Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN) (I CAN)

April 15, 2026 updated by: Alexion Pharmaceuticals, Inc.

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
510

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Ciudad de Buenos Aires, Argentina, C1015ABO
        • Recruiting
        • Research Site
      • Ciudad de Buenos Aires, Argentina, C1425AGC
        • Recruiting
        • Research Site
      • Córdoba, Argentina, X5016KET
        • Recruiting
        • Research Site
      • La Plata, Argentina, B1902COS
        • Recruiting
        • Research Site
      • Rosario, Argentina, 2000
        • Recruiting
        • Research Site
      • San Juan Bautista, Argentina, 1888
        • Withdrawn
        • Research Site
  • Australia
      • Camperdown, Australia, 2050
        • Withdrawn
        • Research Site
      • Canberra, Australia, 2605
        • Active, not recruiting
        • Research Site
      • Clayton, Australia, 3168
        • Active, not recruiting
        • Research Site
      • Concord, Australia, 2139
        • Active, not recruiting
        • Research Site
      • Herston, Australia, 4029
        • Active, not recruiting
        • Research Site
      • Liverpool, Australia, 2170
        • Active, not recruiting
        • Research Site
      • Parkville, Australia, 3050
        • Withdrawn
        • Research Site
      • Perth, Australia, 6000
        • Active, not recruiting
        • Research Site
      • Southport, Australia, 4222
        • Active, not recruiting
        • Research Site
      • St Albans, Australia, 3021
        • Active, not recruiting
        • Research Site
  • Austria
      • Graz, Austria, 8036
        • Active, not recruiting
        • Research Site
      • Innsbruck, Austria, 6020
        • Active, not recruiting
        • Research Site
      • Linz, Austria, 4020
        • Active, not recruiting
        • Research Site
  • Belgium
      • Brussels, Belgium, 1090
        • Active, not recruiting
        • Research Site
      • Edegem, Belgium, 2650
        • Terminated
        • Research Site
      • Leuven, Belgium, 3000
        • Active, not recruiting
        • Research Site
  • Brazil
      • Belo Horizonte, Brazil, 30150-221
        • Active, not recruiting
        • Research Site
      • Belo Horizonte, Brazil, 30110-934
        • Active, not recruiting
        • Research Site
      • Botucatu, Brazil, 18618-687
        • Active, not recruiting
        • Research Site
      • Curitiba, Brazil, 80440-020
        • Active, not recruiting
        • Research Site
      • Fortaleza, Brazil, 60430-270
        • Active, not recruiting
        • Research Site
      • Recife, Brazil, 50670-901
        • Active, not recruiting
        • Research Site
      • Ribeirão Preto, Brazil, 14051-140
        • Active, not recruiting
        • Research Site
      • São José do Rio Preto, Brazil, 15090-000
        • Active, not recruiting
        • Research Site
      • São Paulo, Brazil, 04038-002
        • Active, not recruiting
        • Research Site
      • São Paulo, Brazil, 05403-000
        • Active, not recruiting
        • Research Site
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2V 3M3
        • Recruiting
        • Research Site
    • Ontario
      • Brampton, Ontario, Canada, L6T 5T6
        • Recruiting
        • Research Site
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • Research Site
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • Research Site
  • Chile
      • Araucania, Chile, 4781151
        • Active, not recruiting
        • Research Site
      • Providencia, Chile, 7500000
        • Active, not recruiting
        • Research Site
      • Santiago, Chile, 8330034
        • Active, not recruiting
        • Research Site
      • Santiago, Chile, 7500922
        • Active, not recruiting
        • Research Site
      • Valdivia, Chile, 5090146
        • Active, not recruiting
        • Research Site
  • China
      • Baotou, China, 14010
        • Active, not recruiting
        • Research Site
      • Beijing, China, 100044
        • Active, not recruiting
        • Research Site
      • Beijing, China, 100029
        • Active, not recruiting
        • Research Site
      • Beijing, China, 100034
        • Active, not recruiting
        • Research Site
      • Changsha, China, 410013
        • Active, not recruiting
        • Research Site
      • Changzhou, China, 272100
        • Active, not recruiting
        • Research Site
      • Chengdu, China, 610072
        • Active, not recruiting
        • Research Site
      • Chengdu, China, 610000
        • Active, not recruiting
        • Research Site
      • Chongqing, China, 400010
        • Completed
        • Research Site
      • Guangzhou, China, 510100
        • Active, not recruiting
        • Research Site
      • Hangzhou, China, 310003
        • Active, not recruiting
        • Research Site
      • Jinan, China, 250021
        • Active, not recruiting
        • Research Site
      • Jinhua, China, 321000
        • Recruiting
        • Research Site
      • Lanzhou, China, 730000
        • Active, not recruiting
        • Research Site
      • Luoyang, China, 471000
        • Active, not recruiting
        • Research Site
      • Nanchang, China, 330006
        • Active, not recruiting
        • Research Site
      • Nanchang, China, 330008
        • Active, not recruiting
        • Research Site
      • Nanjing, China, 210029
        • Active, not recruiting
        • Research Site
      • Nanjing, China, 210009
        • Active, not recruiting
        • Research Site
      • Nanjing, China, 210011
        • Active, not recruiting
        • Research Site
      • Ningbo, China, 315010
        • Active, not recruiting
        • Research Site
      • Qingdao, China, 110016
        • Active, not recruiting
        • Research Site
      • Shanghai, China, 200040
        • Recruiting
        • Research Site
      • Shanghai, China, 200065
        • Recruiting
        • Research Site
      • Shanghai, China, 200025
        • Active, not recruiting
        • Research Site
      • Shenzhen, China, 518053
        • Active, not recruiting
        • Research Site
      • Shenzhen, China, 518036
        • Active, not recruiting
        • Research Site
      • Wuhan, China, 430060
        • Active, not recruiting
        • Research Site
      • Wuxi, China, 214023
        • Active, not recruiting
        • Research Site
      • Xi'an, China, 710061
        • Active, not recruiting
        • Research Site
      • Yantai, China, 264000
        • Active, not recruiting
        • Research Site
      • Yibin, China, 610500
        • Active, not recruiting
        • Research Site
      • Yinchuan, China, 750004
        • Active, not recruiting
        • Research Site
      • Zhengzhou, China, 450052
        • Active, not recruiting
        • Research Site
      • Zhongshan, China, 528401
        • Withdrawn
        • Research Site
      • Ürümqi, China, 831118
        • Active, not recruiting
        • Research Site
  • Czechia
      • Nový Jičín, Czechia, 741 01
        • Active, not recruiting
        • Research Site
      • Prague, Czechia, 140 00
        • Active, not recruiting
        • Research Site
      • Prague, Czechia, 128 00
        • Active, not recruiting
        • Research Site
  • France
      • Amiens, France, 80054
        • Active, not recruiting
        • Research Site
      • Bayonne, France, 64100
        • Recruiting
        • Research Site
      • Brest, France, 29200
        • Active, not recruiting
        • Research Site
      • Chambéry, France, 73011
        • Active, not recruiting
        • Research Site
      • Le Kremlin-Bicêtre, France, 94270
        • Active, not recruiting
        • Research Site
      • Marseille, France, 13385
        • Active, not recruiting
        • Research Site
      • Nantes, France, 44093
        • Active, not recruiting
        • Research Site
      • Paris, France, 75015
        • Active, not recruiting
        • Research Site
      • Paris, France, 75010
        • Active, not recruiting
        • Research Site
      • Saint-Priest-en-Jarez, France, 42270
        • Active, not recruiting
        • Research Site
      • Strasbourg, France, 67091
        • Active, not recruiting
        • Research Site
      • Toulouse, France, 31059
        • Active, not recruiting
        • Research Site
  • Germany
      • Aachen, Germany, 52074
        • Active, not recruiting
        • Research Site
      • Berlin, Germany, 10117
        • Active, not recruiting
        • Research Site
      • Cologne, Germany, 50937
        • Recruiting
        • Research Site
      • Erlangen, Germany, 91054
        • Active, not recruiting
        • Research Site
      • Essen, Germany, 45122
        • Active, not recruiting
        • Research Site
      • Greifswald, Germany, 17475
        • Active, not recruiting
        • Research Site
      • Hanover, Germany, 30625
        • Active, not recruiting
        • Research Site
      • Konstanz, Germany, 78464
        • Withdrawn
        • Research Site
      • Mainz, Germany, 55131
        • Active, not recruiting
        • Research Site
      • München, Germany, 81377
        • Active, not recruiting
        • Research Site
      • München, Germany, 81657
        • Active, not recruiting
        • Research Site
      • Villingen-Schwenningen, Germany, 78052
        • Terminated
        • Research Site
  • Greece
      • Athens, Greece, 12462
        • Active, not recruiting
        • Research Site
      • Athens, Greece, 11527
        • Active, not recruiting
        • Research Site
      • Heraklion, Greece, 71500
        • Active, not recruiting
        • Research Site
      • Pátrai, Greece, 26504
        • Recruiting
        • Research Site
      • Thessaloniki, Greece, 57010
        • Active, not recruiting
        • Research Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Active, not recruiting
        • Research Site
      • Hong Kong, Hong Kong, 999077
        • Active, not recruiting
        • Research Site
  • Israel
      • Haifa, Israel, 3109601
        • Active, not recruiting
        • Research Site
      • Jerusalem, Israel, 91120
        • Active, not recruiting
        • Research Site
      • Nazareth, Israel, 16100
        • Active, not recruiting
        • Research Site
      • Petah Tikva, Israel, 49372
        • Active, not recruiting
        • Research Site
      • Tel Aviv, Israel, 6423906
        • Active, not recruiting
        • Research Site
  • Italy
      • Agrigento, Italy, 92100
        • Active, not recruiting
        • Research Site
      • Bologna, Italy, 40138
        • Active, not recruiting
        • Research Site
      • Brescia, Italy, 25123
        • Active, not recruiting
        • Research Site
      • Cagliari, Italy, 09121
        • Active, not recruiting
        • Research Site
      • Florence, Italy, 50134
        • Active, not recruiting
        • Research Site
      • Milan, Italy, 20132
        • Active, not recruiting
        • Research Site
      • Milan, Italy, 20122
        • Active, not recruiting
        • Research Site
      • Padova, Italy, 35128
        • Active, not recruiting
        • Research Site
      • Parma, Italy, 43126
        • Active, not recruiting
        • Research Site
      • Torino, Italy, 10154
        • Active, not recruiting
        • Research Site
      • Torrette, Italy, 60126
        • Active, not recruiting
        • Research Site
      • Verona, Italy, 37126
        • Active, not recruiting
        • Research Site
  • Japan
      • Bunkyō City, Japan, 113-8431
        • Active, not recruiting
        • Research Site
      • Chiba, Japan, 260-8712
        • Active, not recruiting
        • Research Site
      • Chiba, Japan, 260-8677
        • Active, not recruiting
        • Research Site
      • Fukuoka, Japan, 815-8555
        • Active, not recruiting
        • Research Site
      • Kamakura, Japan, 247-8533
        • Active, not recruiting
        • Research Site
      • Kasugai-shi, Japan, 486-8510
        • Active, not recruiting
        • Research Site
      • Kitakyushu-shi, Japan, 802-8555
        • Active, not recruiting
        • Research Site
      • Kobe, Japan, 650-0047
        • Active, not recruiting
        • Research Site
      • Matsumoto-shi, Japan, 390-8621
        • Active, not recruiting
        • Research Site
      • Matsuyama, Japan, 790-8524
        • Active, not recruiting
        • Research Site
      • Nagoya, Japan, 466-8650
        • Active, not recruiting
        • Research Site
      • Osaka, Japan, 545-8586
        • Active, not recruiting
        • Research Site
      • Osaka, Japan, 534-0021
        • Active, not recruiting
        • Research Site
      • Sapporo, Japan, 060-8604
        • Active, not recruiting
        • Research Site
      • Urayasu-shi, Japan, 279-0021
        • Active, not recruiting
        • Research Site
  • Malaysia
      • Ipoh, Malaysia, 30990
        • Active, not recruiting
        • Research Site
      • Johor Bahru, Malaysia, 80100
        • Active, not recruiting
        • Research Site
      • Kuala Lumpur, Malaysia, 59100
        • Active, not recruiting
        • Research Site
      • Seremban, Malaysia, 70300
        • Active, not recruiting
        • Research Site
      • Taiping, Malaysia, 34000
        • Withdrawn
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Active, not recruiting
        • Research Site
      • Rotterdam, Netherlands, 3045 PM
        • Active, not recruiting
        • Research Site
  • Poland
      • Bialystok, Poland, 15-276
        • Active, not recruiting
        • Research Site
      • Bialystok, Poland, 15-540
        • Active, not recruiting
        • Research Site
      • Krakow, Poland, 31-513
        • Active, not recruiting
        • Research Site
      • Lodz, Poland, 92-213
        • Active, not recruiting
        • Research Site
      • Lublin, Poland, 20-090
        • Active, not recruiting
        • Research Site
      • Olsztyn, Poland, 10-561
        • Active, not recruiting
        • Research Site
      • Poznan, Poland, 60-355
        • Active, not recruiting
        • Research Site
      • Szczecin, Poland, 70-111
        • Active, not recruiting
        • Research Site
      • Warsaw, Poland, 02-507
        • Active, not recruiting
        • Research Site
      • Warsaw, Poland, 02-006
        • Active, not recruiting
        • Research Site
  • Saudi Arabia
      • Dammam, Saudi Arabia, 31444
        • Active, not recruiting
        • Research Site
      • Jeddah, Saudi Arabia, 21499
        • Active, not recruiting
        • Research Site
      • Riyadh, Saudi Arabia, 11211
        • Active, not recruiting
        • Research Site
      • Riyadh, Saudi Arabia, 12231
        • Active, not recruiting
        • Research Site
  • Slovakia
      • Banská Bystrica, Slovakia, 974 01
        • Active, not recruiting
        • Research Site
      • Martin, Slovakia, 03659
        • Active, not recruiting
        • Research Site
  • South Korea
      • Anyang-si, South Korea, 14068
        • Active, not recruiting
        • Research Site
      • Busan, South Korea, 49241
        • Active, not recruiting
        • Research Site
      • Deagu, South Korea, 41944
        • Active, not recruiting
        • Research Site
      • Gwangju, South Korea, 61469
        • Active, not recruiting
        • Research Site
      • Gyeonggi-do, South Korea, 13620
        • Active, not recruiting
        • Research Site
      • Seoul, South Korea, 03080
        • Active, not recruiting
        • Research Site
      • Seoul, South Korea, 03722
        • Active, not recruiting
        • Research Site
      • Seoul, South Korea, 05278
        • Active, not recruiting
        • Research Site
      • Suwon, South Korea, 16499
        • Active, not recruiting
        • Research Site
  • Spain
      • A Coruña, Spain, 15006
        • Active, not recruiting
        • Research Site
      • Alcalá de Henares, Spain, 28805
        • Active, not recruiting
        • Research Site
      • Lleida, Spain, 25198
        • Completed
        • Research Site
      • Madrid, Spain, 28031
        • Active, not recruiting
        • Research Site
      • Madrid, Spain, 28046
        • Withdrawn
        • Research Site
      • Madrid, Spain, 28040
        • Completed
        • Research Site
      • Murcia, Spain, 30120
        • Active, not recruiting
        • Research Site
      • Málaga, Spain, 29010
        • Active, not recruiting
        • Research Site
      • Oviedo, Spain, 33011
        • Active, not recruiting
        • Research Site
      • Seville, Spain, 41013
        • Active, not recruiting
        • Research Site
      • Tarragona, Spain, 09-43005
        • Active, not recruiting
        • Research Site
      • Zaragoza, Spain, 50009
        • Active, not recruiting
        • Research Site
  • Taiwan
      • Kaohsiung City, Taiwan, 833401
        • Active, not recruiting
        • Research Site
      • Kaohsiung City, Taiwan, 80756
        • Active, not recruiting
        • Research Site
      • Kaohsiung City, Taiwan, 81362
        • Active, not recruiting
        • Research Site
      • New Taipei City, Taiwan, 220
        • Active, not recruiting
        • Research Site
      • New Taipei City, Taiwan, 23561
        • Active, not recruiting
        • Research Site
      • Taichung, Taiwan, 40705
        • Active, not recruiting
        • Research Site
      • Taichung, Taiwan
        • Active, not recruiting
        • Research Site
      • Tainan, Taiwan, 70403
        • Active, not recruiting
        • Research Site
      • Taipei, Taiwan, 10002
        • Active, not recruiting
        • Research Site
      • Taoyuan District, Taiwan, 333
        • Active, not recruiting
        • Research Site
  • Thailand
      • Bangkok, Thailand, 10330
        • Active, not recruiting
        • Research Site
      • Bangkok, Thailand, 10400
        • Active, not recruiting
        • Research Site
      • Bangkok, Thailand, 10700
        • Active, not recruiting
        • Research Site
      • Chiang Mai, Thailand, 50200
        • Active, not recruiting
        • Research Site
      • Khon Kaen, Thailand, 40002
        • Active, not recruiting
        • Research Site
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06560
        • Active, not recruiting
        • Research Site
      • Bursa, Turkey (Türkiye), 16059
        • Active, not recruiting
        • Research Site
      • Istanbul, Turkey (Türkiye), 34098
        • Active, not recruiting
        • Research Site
      • Istanbul, Turkey (Türkiye), 34452
        • Active, not recruiting
        • Research Site
      • Kahramanmaraş, Turkey (Türkiye), 46100
        • Withdrawn
        • Research Site
      • Kayseri, Turkey (Türkiye), 38039
        • Active, not recruiting
        • Research Site
      • Kocaeli, Turkey (Türkiye), 41380
        • Active, not recruiting
        • Research Site
      • Konya, Turkey (Türkiye), 42080
        • Active, not recruiting
        • Research Site
      • Pamukkale, Turkey (Türkiye), 20070
        • Withdrawn
        • Research Site
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Active, not recruiting
        • Research Site
      • Doncaster, United Kingdom, DN2 5LT
        • Active, not recruiting
        • Research Site
      • Dundee, United Kingdom, DD1 9SY
        • Withdrawn
        • Research Site
      • Leicester, United Kingdom, Le5 4PW
        • Active, not recruiting
        • Research Site
      • London, United Kingdom, E1 1BB
        • Active, not recruiting
        • Research Site
      • London, United Kingdom, SE1 9RT
        • Withdrawn
        • Research Site
      • Manchester, United Kingdom, M13 9WL
        • Active, not recruiting
        • Research Site
      • Reading, United Kingdom, RG1 5AN
        • Active, not recruiting
        • Research Site
      • Salford, United Kingdom, M6 8HD
        • Withdrawn
        • Research Site
      • Stevenage, United Kingdom, SG1 4AB
        • Active, not recruiting
        • Research Site
  • United States
    • Alabama
      • Alabaster, Alabama, United States, 35007
        • Recruiting
        • Research Site
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Research Site
    • California
      • Loma Linda, California, United States, 92354
        • Recruiting
        • Research Site
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Research Site
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Research Site
      • Los Angeles, California, United States, 90022
        • Recruiting
        • Research Site
      • Orange, California, United States, 92868
        • Recruiting
        • Research Site
      • San Diego, California, United States, 92120
        • Recruiting
        • Research Site
      • San Francisco, California, United States, 94143
        • Recruiting
        • Research Site
      • Stanford, California, United States, 94305
        • Recruiting
        • Research Site
      • Torrance, California, United States, 90502
        • Recruiting
        • Research Site
      • Valencia, California, United States, 91355
        • Recruiting
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Research Site
    • Florida
      • Bay Pines, Florida, United States, 33744
        • Recruiting
        • Research Site
      • Miami, Florida, United States, 33136
        • Recruiting
        • Research Site
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Research Site
    • Georgia
      • Acworth, Georgia, United States, 30101
        • Recruiting
        • Research Site
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Research Site
      • Lawrenceville, Georgia, United States, 30046
        • Recruiting
        • Research Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • Research Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Research Site
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • Research Site
    • Maine
      • Augusta, Maine, United States, 04330
        • Recruiting
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Research Site
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Research Site
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Research Site
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55435
        • Recruiting
        • Research Site
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • Research Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Research Site
    • Nevada
      • North Las Vegas, Nevada, United States, 89086
        • Recruiting
        • Research Site
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Research Site
      • East Setauket, New York, United States, 11733
        • Recruiting
        • Research Site
      • New York, New York, United States, 10016
        • Recruiting
        • Research Site
      • The Bronx, New York, United States, 10468
        • Recruiting
        • Research Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Research Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Recruiting
        • Research Site
    • Texas
      • Arlington, Texas, United States, 76002
        • Recruiting
        • Research Site
      • Houston, Texas, United States, 77030
        • Recruiting
        • Research Site
      • Houston, Texas, United States, 77054
        • Recruiting
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Research Site
      • Shenandoah, Texas, United States, 77384
        • Recruiting
        • Research Site
      • Temple, Texas, United States, 76508
        • Withdrawn
        • Research Site
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo IV q8w
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
Participants will receive placebo via weight-based IV infusion.
Experimental: Ravulizumab IV q8w
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
Participants will receive ravulizumab via weight-based intravenous (IV) infusion.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline, Week 34
Change from Baseline in Glomerular Filtration Rate (eGFR) at Week 106
Time Frame: Baseline, Week 106
Evaluated at final analysis only
Baseline, Week 106

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Evaluated at interim and final analysis
Baseline, Weeks 10, 26, 34, 50, and 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
Evaluated at interim and final analysis
Baseline, Weeks 34, 50, and 106
Change From Baseline in eGFR at Weeks 34 and 50
Time Frame: Baseline, Weeks 34 and 50
Evaluated at interim and final analysis
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
Evaluated at interim and final analysis
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
Evaluated at interim and final analysis
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
Evaluated at interim and final analysis
Baseline, at Each Scheduled Visit Up to Week 106
Annualized eGFR Slope Over 50 Weeks
Time Frame: Baseline, Over 50 Weeks
Evaluated at interim analysis only
Baseline, Over 50 Weeks
Time to First Composite Kidney Event Up to Week 106
Time Frame: Baseline 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
Baseline Up to Week 106
Time to Sustained ≥ 30% eGFR Decline Up to Week 106
Time Frame: Baseline Up to Week 106
Evaluated at final analysis only
Baseline Up to Week 106
Time to Sustained eGFR Decline ≥ 40% Up to Week 106
Time Frame: Baseline Up to Week 106
Evaluated at final analysis only
Baseline Up to Week 106
Use of Alternative IgAN Therapy Up to Week 106
Time Frame: Baseline, Up to Week 106
Evaluated at final analysis only
Baseline, Up to Week 106

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alexion Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 29, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 5, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 19, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D928FC00001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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