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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
510
Participants will receive ravulizumab via weight-based intravenous (IV) infusion.
Participants will receive placebo via weight-based IV infusion.
Change from Baseline in Proteinuria Based on 24-hour Urine Protein Creatinine Ratio (UPCR) at Week 34
Evaluated at interim analysis only
Time frame: Baseline, Week 34
Change from Baseline in Glomerular Filtration Rate (eGFR) at Week 106
Evaluated at final analysis only
Time frame: Baseline, Week 106
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
Time frame: Baseline, Weeks 10, 26, 34, 50, and 106
Change From Baseline in eGFR at Weeks 34 and 50
Evaluated at interim and final analysis
Time frame: Baseline, Weeks 34 and 50
Change From Baseline in Albuminuria at Each Scheduled Visit Up to Week 106
Evaluated at interim and final analysis
Time frame: 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
Time frame: 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
Time frame: Baseline, at Each Scheduled Visit Up to Week 106
Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Weeks 34, 50, and 106
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Research Site
Alabaster, Alabama, United States
RECRUITINGResearch Site
Phoenix, Arizona, United States
RECRUITINGResearch Site
Loma Linda, California, United States
RECRUITINGResearch Site
Los Angeles, California, United States
RECRUITINGResearch Site
Los Angeles, California, United States
RECRUITINGResearch Site
Los Angeles, California, United States
RECRUITINGResearch Site
Orange, California, United States
RECRUITINGResearch Site
San Diego, California, United States
RECRUITINGResearch Site
San Francisco, California, United States
RECRUITINGResearch Site
Stanford, California, United States
RECRUITING...and 257 more locations
Evaluated at interim and final analysis
Time frame: Baseline, Weeks 34, 50, and 106
Annualized eGFR Slope Over 50 Weeks
Evaluated at interim analysis only
Time frame: 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
Time frame: Baseline Up to Week 106
Time to Sustained ≥ 30% eGFR Decline Up to Week 106
Evaluated at final analysis only
Time frame: Baseline Up to Week 106
Time to Sustained eGFR Decline ≥ 40% Up to Week 106
Evaluated at final analysis only
Time frame: Baseline Up to Week 106
Use of Alternative IgAN Therapy Up to Week 106
Evaluated at final analysis only
Time frame: Baseline, Up to Week 106