RecruitingPhase 3NCT06291376
Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)
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)
Sponsor
Alexion Pharmaceuticals, Inc.
Enrollment
510 participants
Start Date
Mar 29, 2024
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- 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 months prior to Screening with no planned change in dose through Week 106.
Exclusion Criteria10
- Diagnosis of rapid progressive glomerulonephritis as measured by eGFR loss ≥ 50% over a period of 3 months prior to Screening.
- Secondary IgAN (eg, due to systemic lupus erythematosus (SLE), cirrhosis, or celiac disease; IgAV-N may be eligible).
- Concomitant clinically significant renal disease other than IgAN.
- Prior use of immunosuppressive treatment within 3 months of screening.
- Uncontrolled diabetes mellitus with glycosylated hemoglobin (HbA1c) \> 8.5%.
- Henoch-Schonlein purpura (IgAV) requiring systemic immunosuppressive therapy within 12 months of Screening.
- History of kidney transplant or planned kidney transplant during the Treatment Period.
- Splenectomy or functional asplenia.
- History of Neisseria meningitidis infection.
- Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization.
Interventions
DRUGRavulizumab
Participants will receive ravulizumab via weight-based intravenous (IV) infusion.
DRUGPlacebo
Participants will receive placebo via weight-based IV infusion.
Locations(267)
View Full Details on ClinicalTrials.gov
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NCT06291376