Study of Ravulizumab in 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.
| Condition(s) | Immunoglobulin A Nephropathy, IgAN |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 RASI (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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Alexion Pharmaceuticals, Inc. |
| Locations | Alabaster, Alabama, United States; Phoenix, Arizona, United States; Loma Linda, California, United States; Los Angeles, California, United States; Los Angeles, California, United States; Los Angeles, California, United States (+261 more sites) |
| Start date | 2024-03-29 |
| NCT ID | NCT06291376 |
| Official listing | https://clinicaltrials.gov/study/NCT06291376 |