nctId: NCT06291376 id: D928FC00001 briefTitle: Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN) acronym: ICAN overallStatus: RECRUITING date: 2024-03-29 date: 2026-02-23 date: 2029-10-25 date: 2024-03-04 date: 2024-04-29 name: Alexion Pharmaceuticals, Inc. class: INDUSTRY briefSummary: 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. conditions: Immunoglobulin A Nephropathy conditions: IgAN studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 470 type: ESTIMATED name: Ravulizumab name: Placebo measure: Change from Baseline in Proteinuria Based on 24-hour Urine Protein Creatinine Ratio (UPCR) at Week 34 measure: Glomerular Filtration Rate (eGFR) Over 106 Weeks measure: Change from Baseline in Proteinuria Based on 24-hour Urine Protein Creatinine Ratio (UPCR) at Weeks 10, 26, 34, 50, and 106 measure: Change From Baseline in eGFR at Weeks 34, 50, and 106 measure: Change From Baseline in Albuminuria Based on Urine Albumin to Creatinine Ratio (UACR) at Weeks 10, 26, 34, 50, and 106 measure: Reduction in 24-hour UPCR ≥ 50% From Baseline to Weeks 10, 26, 34, 50, and 106 measure: Number of Participants With Partial Remission at Weeks 34, 50, and 106 measure: Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Weeks 34, 50, and 106 measure: Number of Participants With Composite Kidney Failure Endpoint measure: Reduction in 24-hour UPCR ≥ 50% From Baseline at both Weeks 34 and 106 measure: Number of Participants With Kidney Hierarchical Composite Endpoint sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: 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