Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

Study Identifier:
D928FC00001
ClinicalTrials.gov Identifier:
NCT06291376
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
1-855-752-2356 or [email protected]
Recruiting

Study Details

Medical Condition
  • Unmapped
  • IgAN
Study Drug
  • Drug: Ravulizumab
  • Drug: Placebo
Date
Mar 2024 - Jan 2026
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
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.
Sex
Female & Male
Age
18+ years

Study Details

Medical Condition
  • Unmapped
  • IgAN
Study Drug
  • Drug: Ravulizumab
  • Drug: Placebo
Date
Mar 2024 - Jan 2026
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information
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.

Trial Locations

Location
Status
Location
Research Site
Alabaster, Alabama, United States, 35007
Status
Recruiting
Location
Research Site
Phoenix, Arizona, United States, 85054
Status
Recruiting
Location
Research Site
Los Angeles, California, United States, 90022
Status
Recruiting
Location
Research Site
Los Angeles, California, United States, 90027
Status
Recruiting
Location
Research Site
Los Angeles, California, United States, 90095
Status
Recruiting
Location
Research Site
Orange, California, United States, 92868
Status
Recruiting
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