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)

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: Active, not recruiting
• Conditions: Immunoglobulin A Nephropathy; IgAN
• Intervention / Treatment: Drug: Ravulizumab; Drug: Placebo

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 (Actual): 579
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad de Buenos Aires, Argentina, C1015ABO
    • Research Site
  • Ciudad de Buenos Aires, Argentina, C1425AGC
    • Research Site
  • Córdoba, Argentina, X5016KET
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  • La Plata, Argentina, B1902COS
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  • Rosario, Argentina, 2000
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• Australia
  • Canberra, Australia, 2605
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  • Clayton, Australia, 3168
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  • Concord, Australia, 2139
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  • Herston, Australia, 4029
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  • Liverpool, Australia, 2170
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  • Perth, Australia, 6000
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  • Southport, Australia, 4222
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  • St Albans, Australia, 3021
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• Austria
  • Graz, Austria, 8036
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  • Innsbruck, Austria, 6020
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  • Linz, Austria, 4020
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• Belgium
  • Brussels, Belgium, 1090
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  • Edegem, Belgium, 2650
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  • Leuven, Belgium, 3000
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• Brazil
  • Belo Horizonte, Brazil, 30110-934
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  • Belo Horizonte, Brazil, 30150-221
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  • Botucatu, Brazil, 18618-687
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  • Curitiba, Brazil, 80440-020
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  • Fortaleza, Brazil, 60430-270
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  • Recife, Brazil, 50670-901
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  • Ribeirão Preto, Brazil, 14051-140
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  • São José do Rio Preto, Brazil, 15090-000
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  • São Paulo, Brazil, 05403-000
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  • São Paulo, Brazil, 04038-002
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• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2V 3M3
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  • Ontario
    • Brampton, Ontario, Canada, L6T 5T6
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    • London, Ontario, Canada, N6A 5W9
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    • Toronto, Ontario, Canada, M5G 2C4
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• Chile
  • Araucania, Chile, 4781151
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  • Providencia, Chile, 7500000
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  • Santiago, Chile, 8330034
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  • Santiago, Chile, 7500922
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  • Valdivia, Chile, 5090146
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• China
  • Baotou, China, 14010
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  • Beijing, China, 100034
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  • Beijing, China, 100029
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  • Beijing, China, 100044
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  • Changsha, China, 410013
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  • Changzhou, China, 272100
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  • Chengdu, China, 610000
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  • Chengdu, China, 610072
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  • Chongqing, China, 400010
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  • Guangzhou, China, 510100
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  • Hangzhou, China, 310003
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  • Jinan, China, 250021
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  • Jinhua, China, 321000
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  • Lanzhou, China, 730000
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  • Luoyang, China, 471000
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  • Nanchang, China, 330006
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  • Nanchang, China, 330008
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  • Nanjing, China, 210009
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  • Nanjing, China, 210029
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  • Nanjing, China, 210011
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  • Ningbo, China, 315010
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  • Qingdao, China, 110016
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  • Shanghai, China, 200025
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  • Shanghai, China, 200065
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  • Shanghai, China, 200040
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  • Shenzhen, China, 518036
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  • Shenzhen, China, 518053
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  • Wuhan, China, 430060
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  • Wuxi, China, 214023
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  • Xi'an, China, 710061
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  • Yantai, China, 264000
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  • Yibin, China, 610500
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  • Yinchuan, China, 750004
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  • Zhengzhou, China, 450052
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  • Ürümqi, China, 831118
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• Czechia
  • Nový Jičín, Czechia, 741 01
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  • Prague, Czechia, 140 00
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  • Prague, Czechia, 128 00
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• France
  • Amiens, France, 80054
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  • Bayonne, France, 64100
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  • Brest, France, 29200
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  • Chambéry, France, 73011
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  • Le Kremlin-Bicêtre, France, 94270
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  • Marseille, France, 13385
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  • Nantes, France, 44093
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  • Paris, France, 75010
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  • Paris, France, 75015
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  • Saint-Priest-en-Jarez, France, 42270
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  • Strasbourg, France, 67091
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  • Toulouse, France, 31059
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• Germany
  • Aachen, Germany, 52074
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  • Berlin, Germany, 10117
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  • Erlangen, Germany, 91054
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  • Essen, Germany, 45122
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  • Greifswald, Germany, 17475
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  • Hanover, Germany, 30625
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  • Mainz, Germany, 55131
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  • München, Germany, 81377
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  • München, Germany, 81657
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  • Villingen-Schwenningen, Germany, 78052
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• Greece
  • Athens, Greece, 11527
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  • Athens, Greece, 12462
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  • Heraklion, Greece, 71500
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  • Thessaloniki, Greece, 57010
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• Hong Kong
  • Hong Kong, Hong Kong
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  • Hong Kong, Hong Kong, 999077
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• Israel
  • Haifa, Israel, 3109601
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  • Jerusalem, Israel, 91120
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  • Nazareth, Israel, 16100
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  • Petah Tikva, Israel, 49372
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  • Tel Aviv, Israel, 6423906
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• Italy
  • Agrigento, Italy, 92100
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  • Bologna, Italy, 40138
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  • Brescia, Italy, 25123
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  • Cagliari, Italy, 09121
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  • Florence, Italy, 50134
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  • Milan, Italy, 20122
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  • Milan, Italy, 20132
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  • Padova, Italy, 35128
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  • Parma, Italy, 43126
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  • Torino, Italy, 10154
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  • Torrette, Italy, 60126
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  • Verona, Italy, 37126
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• Japan
  • Bunkyō City, Japan, 113-8431
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  • Chiba, Japan, 260-8677
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  • Chiba, Japan, 260-8712
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  • Fukuoka, Japan, 815-8555
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  • Kamakura, Japan, 247-8533
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  • Kasugai-shi, Japan, 486-8510
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  • Kitakyushu-shi, Japan, 802-8555
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  • Kobe, Japan, 650-0047
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  • Matsumoto-shi, Japan, 390-8621
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  • Matsuyama, Japan, 790-8524
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  • Nagoya, Japan, 466-8650
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  • Osaka, Japan, 545-8586
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  • Osaka, Japan, 534-0021
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  • Sapporo, Japan, 060-8604
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  • Urayasu-shi, Japan, 279-0021
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• Malaysia
  • Ipoh, Malaysia, 30990
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  • Johor Bahru, Malaysia, 80100
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  • Kuala Lumpur, Malaysia, 59100
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  • Seremban, Malaysia, 70300
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• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
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  • Rotterdam, Netherlands, 3045 PM
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• Poland
  • Bialystok, Poland, 15-276
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  • Bialystok, Poland, 15-540
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  • Krakow, Poland, 31-513
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  • Lodz, Poland, 92-213
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  • Lublin, Poland, 20-090
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  • Olsztyn, Poland, 10-561
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  • Poznan, Poland, 60-355
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  • Szczecin, Poland, 70-111
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  • Warsaw, Poland, 02-507
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  • Warsaw, Poland, 02-006
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• Saudi Arabia
  • Dammam, Saudi Arabia, 31444
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  • Jeddah, Saudi Arabia, 21499
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  • Riyadh, Saudi Arabia, 12231
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  • Riyadh, Saudi Arabia, 11211
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• Slovakia
  • Banská Bystrica, Slovakia, 974 01
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  • Martin, Slovakia, 03659
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• South Korea
  • Anyang-si, South Korea, 14068
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  • Busan, South Korea, 49241
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  • Deagu, South Korea, 41944
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  • Gwangju, South Korea, 61469
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  • Gyeonggi-do, South Korea, 13620
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  • Seoul, South Korea, 03080
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  • Seoul, South Korea, 03722
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  • Seoul, South Korea, 05278
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  • Suwon, South Korea, 16499
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• Spain
  • A Coruña, Spain, 15006
    • Research Site
  • Alcalá de Henares, Spain, 28805
    • Research Site
  • Lleida, Spain, 25198
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  • Madrid, Spain, 28031
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  • Madrid, Spain, 28040
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  • Murcia, Spain, 30120
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  • Málaga, Spain, 29010
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  • Oviedo, Spain, 33011
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  • Seville, Spain, 41013
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  • Tarragona, Spain, 09-43005
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  • Zaragoza, Spain, 50009
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• Taiwan
  • Kaohsiung City, Taiwan, 80756
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  • Kaohsiung City, Taiwan, 833401
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  • Kaohsiung City, Taiwan, 81362
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  • New Taipei City, Taiwan, 220
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  • New Taipei City, Taiwan, 23561
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  • Taichung, Taiwan, 40705
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  • Taichung, Taiwan
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  • Tainan, Taiwan, 70403
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  • Taipei, Taiwan, 10002
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  • Taoyuan, Taiwan, 333
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• Thailand
  • Bangkok, Thailand, 10330
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  • Bangkok, Thailand, 10400
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  • Bangkok, Thailand, 10700
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  • Chiang Mai, Thailand, 50200
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  • Khon Kaen, Thailand, 40002
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• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06560
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  • Bursa, Turkey (Türkiye), 16059
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  • Istanbul, Turkey (Türkiye), 34098
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  • Istanbul, Turkey (Türkiye), 34452
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  • Kayseri, Turkey (Türkiye), 38039
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  • Kocaeli, Turkey (Türkiye), 41380
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  • Konya, Turkey (Türkiye), 42080
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• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
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  • Doncaster, United Kingdom, DN2 5LT
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  • Leicester, United Kingdom, Le5 4PW
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  • London, United Kingdom, E1 1BB
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  • Manchester, United Kingdom, M13 9WL
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  • Reading, United Kingdom, RG1 5AN
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  • Stevenage, United Kingdom, SG1 4AB
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• United States
  • Alabama
    • Alabaster, Alabama, United States, 35007
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  • Arizona
    • Phoenix, Arizona, United States, 85054
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  • California
    • Los Angeles, California, United States, 90027
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    • Los Angeles, California, United States, 90022
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    • Los Angeles, California, United States, 90095
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    • Orange, California, United States, 92868
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    • San Bernardino, California, United States, 92408
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    • San Diego, California, United States, 92120
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    • San Francisco, California, United States, 94143
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    • Stanford, California, United States, 94305
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    • Torrance, California, United States, 90502
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    • Valencia, California, United States, 91355
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  • Florida
    • Bay Pines, Florida, United States, 33744
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    • Miami, Florida, United States, 33136
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    • Orlando, Florida, United States, 32806
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  • Georgia
    • Acworth, Georgia, United States, 30101
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    • Atlanta, Georgia, United States, 30322
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    • Lawrenceville, Georgia, United States, 30046
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  • Louisiana
    • New Orleans, Louisiana, United States, 70121
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  • Massachusetts
    • Boston, Massachusetts, United States, 02111
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    • Boston, Massachusetts, United States, 02115
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    • Boston, Massachusetts, United States, 02114
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    • Worcester, Massachusetts, United States, 01655
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  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
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    • Minneapolis, Minnesota, United States, 55435
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  • Missouri
    • Kansas City, Missouri, United States, 64111
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  • Nevada
    • North Las Vegas, Nevada, United States, 89086
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  • New York
    • Albany, New York, United States, 12208
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    • New York, New York, United States, 10016
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    • The Bronx, New York, United States, 10468
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  • Ohio
    • Columbus, Ohio, United States, 43210
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  • Tennessee
    • Knoxville, Tennessee, United States, 37920
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  • Texas
    • Arlington, Texas, United States, 76002
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    • Houston, Texas, United States, 77030
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    • Houston, Texas, United States, 77054
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    • San Antonio, Texas, United States, 78229
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    • Shenandoah, Texas, United States, 77384
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  • Virginia
    • Charlottesville, Virginia, United States, 22908
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  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
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Participation Criteria

Eligibility Criteria

• 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 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

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	Evaluated at interim analysis only	Baseline, Week 34
Change from Baseline in Glomerular Filtration Rate (eGFR) at Week 106	Evaluated at final analysis only	Baseline, Week 106

Secondary 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	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	Evaluated at interim and final analysis	Baseline, Weeks 34, 50, and 106
Change From Baseline in eGFR at 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	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	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	Evaluated at interim and final analysis	Baseline, at Each Scheduled Visit Up to Week 106
Annualized eGFR Slope Over 50 Weeks	Evaluated at interim analysis only	Baseline, Over 50 Weeks
Time to First Composite Kidney Event 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	Evaluated at final analysis only	Baseline Up to Week 106
Time to Sustained eGFR Decline ≥ 40% Up to Week 106	Evaluated at final analysis only	Baseline Up to Week 106
Use of Alternative IgAN Therapy Up to Week 106	Evaluated at final analysis only	Baseline, Up to Week 106
Change from Baseline in Proteinuria Based on 24-hour UPCR at Week 34 with baseline UPCR ≥ 1.5 g/g	Evaluated at final analysis only	Baseline Up to Week 34
Change from Baseline in Proteinuria Based on 24-hour UPCR at Week 34 in Participants with Baseline UPCR ≥ 1.5 g/g and Presence of Hematuria at Baseline	Evaluated at final analysis only	Baseline Up to Week 34
Change from Baseline in eGFR at Week 106 in Participants with Baseline UPCR ≥ 1.5 g/g	Evaluated at final analysis only	Baseline Up to Week 106

Collaborators and Investigators

• Sponsor: Alexion Pharmaceuticals, Inc.

Publications and helpful links

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

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): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: proteinuria; chronic kidney disease; CKD; IgAN; Immunoglobulin A nephropathy; glomerulonephropathy
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Autoimmune Diseases; Immune System Diseases; Urination Disorders; Urological Manifestations; Renal Insufficiency; Glomerulonephritis; Nephritis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Renal Insufficiency, Chronic; Glomerulonephritis, IGA; Proteinuria; Substandard Drugs; Pharmaceutical Preparations; ravulizumab
• 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: No