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Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-03-29
Primary completion: 2026-02-23
Study completion finish: 2029-10-25
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT06291376
Intervention or treatment
DRUG: Ravulizumab
DRUG: Placebo
Conditions
- • Immunoglobulin A Nephropathy
- • IgAN
Find a site
Closest Location:
Research Site
Research sites nearby
Select from list below to view details:
Research Site
Camperdown, Not Specified, Australia
Research Site
Canberra, Not Specified, Australia
Research Site
Clayton, Not Specified, Australia
Research Site
Concord, Not Specified, Australia
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?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Ravulizumab IV q8w
| DRUG: Ravulizumab
|
PLACEBO_COMPARATOR: Placebo IV q8w
| DRUG: Placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome 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 |
Glomerular Filtration Rate (eGFR) Over 106 Weeks | Evaluated at final analysis only | Up to Week 106 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome 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 eGFR at Weeks 34, 50, and 106 | Evaluated at interim and final analysis | Baseline, Weeks 34, 50, and 106 |
Change From Baseline in Albuminuria Based on Urine Albumin to Creatinine Ratio (UACR) at Weeks 10, 26, 34, 50, and 106 | Evaluated at interim and final analysis | Baseline, Weeks 10, 26, 34,50, and 106 |
Reduction in 24-hour UPCR ≥ 50% From Baseline to Weeks 10, 26, 34, 50, and 106 | Evaluated at interim and final analysis | Baseline, Weeks 10, 26, 34, 50, and 106 |
Number of Participants With Partial Remission at Weeks 34, 50, and 106 | Evaluated at interim and final analysis | Weeks 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 |
Number of Participants With Composite Kidney Failure Endpoint | Composite kidney failure 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 the final analysis only | Baseline up to Week 106 |
Reduction in 24-hour UPCR ≥ 50% From Baseline at both Weeks 34 and 106 | Evaluated at the final analysis only | Baseline, Weeks 34 and 106 |
Number of Participants With Kidney Hierarchical Composite Endpoint | The kidney hierarchical composite endpoint is defined as the most severe outcome of a participant according to the following severity of outcomes: death from kidney failure, kidney transplant, maintenance dialysis, sustained eGFR \< 15 mL/min/1.73 m\^2, sustained eGFR decline from baseline ≥ 30%, or eGFR slope. Evaluated at the final analysis only | Baseline up to Week 106 |
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