Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Immunoglobulin A Nephropathy,IgAN
Age
18+
Phase
PHASE3
Participants Needed
510
Est. Completion Date
Jul 19, 2030
Treatment Type
INTERVENTIONAL
Sponsor
Alexion Pharmaceuticals, Inc.
ClinicalTrials.gov NCT Identifier
NCT06291376
Study Number
ALXN1220-IgAN-320
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