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)

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. Interim Analysis-To evaluate the efficacy of ravulizumab compared with placebo to reduce proteinuria in adult participants with IgAN Final Analysis-To evaluate the efficacy of ravulizumab compared with placebo on change in eGFR in adult participants with IgAN

CT.gov Identifier
NCT06291376
EudraCT Identifier
N/A
CTIS:
2023-507851-31-00
Sponsor
AstraZeneca/Alexion Pharmaceuticals
Collaborator
N/A
Study Contact Information
+44 20 3749 5000
Recruiting
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Study Details

Diseases
IgA nephropathy
Study Drug
Ravulizumab
Genes
N/A
Study Dates
Mar 2024 - Jan 2026
Sex
Female & Male
Age
18+ years
Inclusion and Exclusion Criteria
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 months prior to Screening with no planned change in dose through Week 106.
Exclusion Criteria:
  • 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.

Protocol 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. Interim Analysis-To evaluate the efficacy of ravulizumab compared with placebo to reduce proteinuria in adult participants with IgAN Final Analysis-To evaluate the efficacy of ravulizumab compared with placebo on change in eGFR in adult participants with IgAN

Study Locations

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