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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

510

Phase

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

Name: Alexion Pharmaceuticals, Inc. (Sponsor)
Phone Number: 1-855-752-2356
Email: clinicaltrials@alexion.com

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    - Withdrawn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    - Withdrawn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

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

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

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

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

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

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.

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)

March 29, 2024

Primary Completion (Actual)

January 5, 2026

Study Completion (Estimated)

July 19, 2030

Study Registration Dates

First Submitted

February 26, 2024

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Actual)

March 4, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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

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.

Clinical Trials on Immunoglobulin A Nephropathy

Biogen
Human Immunology Biosciences, Inc. (HI-Bio)

Recruiting

A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN) (PREVAIL)

Immunoglobulin A Nephropathy (IgAN)

China, Spain, United States, Australia, Japan, Belgium, Germany, New Zealand, India, Brazil, Puerto Rico, Malaysia, United Kingdom, Bulgaria, Greece, Taiwan, France, Argentina, Croatia, Czechia, Portugal, South Korea, Poland, Canada, Co... and more
Hansoh BioMedical R&D Company

Not yet recruiting

A Study of the Effect and Safety of HS-10390 in the Treatment of Patients with Primary IgA Nephropathy

Immunoglobulin a Nephropathy

China
Peking University First Hospital

Enrolling by invitation

A Study of Cizutamig in Patients With Immunoglobulin A Nephropathy

Immunoglobulin A Nephropathy (IgAN)

China
Everest Medicines (Singapore) Pte. Ltd.

Completed

Efficacy and Safety in Chinese Patients with Immunoglobulin a Nephropathy (IgAN) Who Have Completed Study Nef-301

Primary Immunoglobulin a Nephropathy (IgAN)

China
Chinese University of Hong Kong

Withdrawn

Paricalcitol for the Treatment of Immunoglobulin A Nephropathy

IgA Nephropathy

Hong Kong
Baxalta now part of Shire

Withdrawn

Efficacy and Safety of SM101 in the Treatment of IgA Nephropathy

Immunoglobulin A Nephropathy
Novartis Pharmaceuticals

Recruiting

Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Iptacopan in Pediatric Patients With Primary IgAN

Primary Immunoglobulin A Nephropathy (IgAN)

United States, Hong Kong, China, Australia, Israel, Japan
Wuhan Createrna Science and Technology Co., Ltd

Not yet recruiting

Study to Evaluate the Efficacy and Safety of MY008211A in Subjects with Primary Immunoglobulin a Nephropathy (IgAN)

IgA Nephropathy (IgAN)

China
Otsuka Pharmaceutical Development & Commercialization...

Completed

First in Human Study to Assess Safety of VIS649 in Healthy Subjects

Immunoglobulin A Nephropathy | IgA Nephropathy | IgAN - IgA Nephropathy

United States
Walden Biosciences

Recruiting

Study of WAL0921 in Patients With Glomerular Kidney Diseases

Diabetic Nephropathies | Minimal Change Disease | Primary Focal Segmental Glomerulosclerosis | Primary Membranous Nephropathy | Primary Immunoglobulin A Nephropathy

Australia, United States, Malaysia, India, United Kingdom, South Korea, Sri Lanka

Clinical Trials on Ravulizumab

Alexion Pharmaceuticals, Inc.

Not yet recruiting

Efficacy and Safety of Ravulizumab in Chinese Adults Participants With Generalized Myasthenia Gravis (gMG)

Generalized Myasthenia Gravis | gMG
AstraZeneca

Not yet recruiting

Ravulizumab Outcomes in Polish Patients With aHUS (aHUS-OPTIMUM)

Atypical Hemolytic Uremic Syndrome
Alexion Pharmaceuticals, Inc.

Recruiting

Post-Marketing Clinical Study of Ravulizumab in Participants With Clinical aHUS

Atypical Hemolytic Uremic Syndrome | aHUS

Japan
Alexion Pharmaceuticals, Inc.

Not yet recruiting

Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Study of Ravulizumab in Chinese Adults With Neuromyelitis Optica Spectrum Disorder (NMOSD)

Neuromyelitis Optica Spectrum Disorder | NMOSD
Alexion Pharmaceuticals, Inc.

Recruiting

Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab Administered Intravenously in Adult Participants at High Risk of Delayed Graft Function After Kidney Transplantation (AWAKE)

Kidney Transplant | Delayed Graft Function | DGF

United States, China, Spain, Germany, Italy, Poland, United Kingdom, Brazil, France, Taiwan, Australia, Austria, Canada, Japan, Argentina, Czechia, South Korea, Portugal
Alexion Pharmaceuticals, Inc.

Active, not recruiting

ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKE (ARTEMIS)

Chronic Kidney Disease | CKD | Cardiopulmonary Bypass | Cardiac Disease

United States, Canada, France, Germany, Spain, Italy, Brazil, China, Taiwan, Netherlands, United Kingdom, Japan, Israel, Australia, Poland, India, Austria, Argentina, Hong Kong, South Korea, Turkey (Türkiye)
Alexion Pharmaceuticals, Inc.

Recruiting

Early Ravulizumab Treatment Of Anti- AChR Antibody-Positive Generalized Myasthenia Gravis

Generalized Myasthenia Gravis | Anti-AChR Antibody Positive

Italy
AstraZeneca

Active, not recruiting

Real-life Treatment Outcomes of Ravulizumab in PNH (PNH-RECORD)

Paroxysmal Nocturnal Haemoglobinuria

Poland
Centre Hospitalier Universitaire de Nice

Recruiting

Evaluation of the Condition of Patients Receiving EARLY Ravulizumab and Admitted in ICU for gMG Crisis (EARLY-MG)

Myasthenia Gravis

France
Alexion Pharmaceuticals, Inc.

Completed

Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Ravulizumab in Chinese Adults Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Paroxysmal Nocturnal Hemoglobinuria | PNH

China

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)

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Immunoglobulin A Nephropathy

Clinical Trials on Ravulizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations