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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)

Status: Recruiting

To evaluate the efficacy of ravulizumab compared with placebo to reduce proteinuria in adult participants with IgAN

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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Immunoglobulin A Nephropathy (IgAN) diagnosis established on kidney biopsy
• stable and maximum allowed or tolerated RASI (ACEI and/or ARB) dose for ≥ 3 months prior to starting the study
• if receiving SGLT2I, DEARA, MRA or ERA must be on a stable and maximum allowed or tolerated dose for ≥ 3 months prior to starting the study
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• diagnosis of rapid progressive glomerulonephritis
• clinically significant renal disease other than IgAN
• uncontrolled diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8.5%
• history of kidney transplant or planned kidney transplant
• see link to clinicaltrials.gov for complete Exclusion criteria
Interventions:

Drug: Placebo, Drug: Ravulizumab

Conditions:

Kidney, Prostate & Urinary

Keywords:

Clinics and Surgery Center (CSC), iga Nephropathy, igan, Lupus Nephritis, Immunoglobulin A Nephropathy

Study Contact: Sahar Koubar - skoubar@umn.edu
Principal Investigator: Sahar Koubar
Phase: PHASE3
IRB Number: STUDY00021814
See this study on ClinicalTrials.gov

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