ALXN1210-IgAN-302- I CAN - Phase 3 Study of Ravulizumab in Adults with Immunoglobulin A Nephropathy
Research type
Research Study
Full title
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)
IRAS ID
1009670
Contact name
Katherine Garlo
Contact email
Sponsor organisation
Alexion Pharmaceuticals, Inc.
Clinicaltrials.gov Identifier
Research summary
The purpose of this phase 3 study is to see if ravulizumab, the study drug, is safe and works better compared to placebo in adult patients with Immunoglobulin A Nephropathy (IgAN) also known as Berger’s disease. This study aims to assess, but not limited to, the following:
- Measures of kidney function
- Side effects of ravulizumab, how often they happen and the severity of side effects compared to placebo.
- What the body does to ravulizumab, (pharmacokinetics) and what ravulizumab does to the body (pharmacodynamics).
- Evaluate health quality of life outcomes based on health questionnaire completion by the participants.
Ravulizumab works by reducing the inflammatory effect in the kidneys. It does this by inhibiting the action of a protein named C5, which is a part of the body’s natural defence system (known as the complement system). This in turn has the potential to provide a clinically impactful disease modifying and steroid-sparing therapeutic option for patients with IgAN.
This study consists of 3 periods; Screening, Treatment Period and Ravulizumab Access Period (RAP). Participants will enter the Treatment Period if they meet the Screening eligibility requirements and will be split into 2 cohorts; Main Cohort and Exploratory Cohort. Patients who have progressive end stage kidney disease which is evident upon laboratory test results will be assigned to the exploratory cohort and will receive ravulizumab. Patients assigned in the Main Cohort will have a 50% chance of being randomly assigned to receive ravulizumab or placebo. Ravulizumab or placebo will be given to patients every 8 weeks via intravenous infusion. The Treatment Period lasts about 106 weeks (approx. 2 years). After completion of the treatment period, patients will have an option to enter the RAP where they will receive open-label ravulizumab for about 2 years. The total study duration is up to 210 weeks (4 years). Approximately 450 participants worldwide will be enrolled in this study.REC name
London - West London & GTAC Research Ethics Committee
REC reference
24/LO/0182
Date of REC Opinion
2 May 2024
REC opinion
Further Information Favourable Opinion