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
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