Clinical Trials Logo

Clinical Trial Summary

The primary objective of this study to evaluate the efficacy of ravulizumab compared with placebo to reduce proteinuria and slow the rate of eGFR decline in adult participants with IgAN who are at risk of disease progression.


Clinical Trial Description

The I CAN study will enroll approximately 450 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, 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 20 participants with eGFR 20-29 mL/min/1.73m2 will be enrolled in an Exploratory Cohort and will receive open label weight-based IV infusion of ravulizumab. After Week 106, all participants have the option to enter a post-study access period and receive open-label ravulizumab. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06291376
Study type Interventional
Source Alexion Pharmaceuticals, Inc.
Contact Alexion Pharmaceuticals, Inc. (Sponsor)
Phone 1-855-752-2356
Email clinicaltrials@alexion.com
Status Recruiting
Phase Phase 3
Start date March 29, 2024
Completion date October 25, 2029

See also
  Status Clinical Trial Phase
Completed NCT03719443 - First in Human Study to Assess Safety of VIS649 in Healthy Subjects Phase 1
Enrolling by invitation NCT05132621 - The Genital Tract Microflora in Women With Systemic Lupus Erythematosus (SLE) and Immunoglobulin A (IgA) Nephropathy.
Recruiting NCT05856760 - A Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in Participants With IgAN Phase 2
Recruiting NCT04662723 - Multicentre Clinical Study to Evaluate the Effect of Personalized Therapy on Patients With Immunoglobulin A Nephropathy. Phase 4
Completed NCT02384317 - Open-Label Study to Evaluate Safety and Efficacy of CCX168 in Subjects With IGA Nephropathy on Stable RAAS Blockade Phase 2
Recruiting NCT05732402 - An Open-label Study of Povetacicept (ALPN-303) in Autoimmune Kidney Diseases Phase 1/Phase 2
Active, not recruiting NCT05248646 - Visionary Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN) Phase 3
Completed NCT01838239 - Development of a Metabolic Assessment Tool for Chronic Kidney Disease N/A
Recruiting NCT05852938 - A Study of BION-1301 in Adults With IgA Nephropathy Phase 3
Recruiting NCT05834738 - Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy Phase 2
Completed NCT04287985 - Safety and Efficacy Study of VIS649 for IgA Nephropathy Phase 2
Recruiting NCT05097989 - Study of ALXN2050 in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) Phase 2
Completed NCT05200871 - Humanistic Burden of (FSGS) Focal Segmental Glomerulosclerosis and IgAN (Immunoglobulin A Nephropathy)
Terminated NCT05162066 - Study to Evaluate the Safety, Tolerability of BCX9930 in Participants With Either Complement 3 Glomerulopathy (C3G), Immunoglobulin A Nephropathy (IgAN), or Primary Membranous Nephropathy (PMN) Phase 2
Active, not recruiting NCT04573920 - Atrasentan in Patients With Proteinuric Glomerular Diseases Phase 2
Withdrawn NCT02605525 - Efficacy and Safety of SM101 in the Treatment of IgA Nephropathy Phase 2
Recruiting NCT04564339 - Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) Phase 2
Active, not recruiting NCT04573478 - Atrasentan in Patients With IgA Nephropathy Phase 3
Active, not recruiting NCT03762850 - A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy Phase 3
Active, not recruiting NCT04663204 - A Study of the Safety and Activity of Sparsentan for the Treatment of Incident Patients With Immunoglobulin A Nephropathy Phase 2