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Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)
Not Recruiting
Trial ID: NCT06291376
Purpose
The primary objective of this study to evaluate the efficacy of ravulizumab compared with
placebo to reduce proteinuria and slow the rate of eGFR decline in adult participants with
IgAN who are at risk of disease progression.
Official Title
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)
Stanford Investigator(s)
Richard Lafayette
Professor of Medicine (Nephrology)
Eligibility
Inclusion Criteria:
- Documentation of IgAN diagnosis established on kidney biopsy obtained any time prior
to or during the Screening Period.
- UPCR ≥ 0.75 g/g or UP ≥1 g/day from the mean of two 24-hour urine collections during
Screening.
- Estimated GFR ≥ 30 mL/min/1.73 m2 at Screening.
- Exploratory Cohort: eGFR 20-29 mL/min/1.73 m2 at Screening. A kidney biopsy is
required within 6 months prior to Screening or during the Screening Period.
- Presence of hematuria as defined by a positive result on urine dipstick for blood or ≥
5 red blood cells (RBCs)/high power field microscopy on urine sediment during or
within 3 months of 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 on an SGLT2I, ERA, or MRA must be on a stable and maximum allowed
or tolerated dose for ≥ 3 months prior to Screening with no planned change 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).
- Concomitant clinically significant renal disease other than IgAN.
- Prior use of immunosuppressive treatment for IgAN within 6 months of screening.
- Uncontrolled diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8.5%.
- Clinically active Henoch-Schonlein purpura (IgA vasculitis) requiring ongoing systemic
immunosuppressive therapy at 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.
Intervention(s):
drug: Ravulizumab
drug: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Shiktj Dave
650-723-2240