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ph3 IgAN Ravulizumab interventional

UCI Specialty Area: Nephrology
Principal Investigator: Ramy Hanna
Official Title: A Phase 3, Double-Blind, Randomized, Adaptive Design Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Immunoglobulin A Nephropathy (IgAN)
A Study On:
IgA Nephropathy
Kidney - Nephrology

Study Description

The I CAN study will enroll approximately 510 eligible participants with IgAN who are high risk of disease progression. Participants will be on stable concomitant IgAN treatment(s) consistent with standard of care for patients with IgAN for at least 3 months prior to Screening. Approximately 450 participants will be randomized in a 1:1 allocation ratio to receive a weight-based IV infusion of either ravulizumab or placebo. An interim analysis may be conducted at Week 34 to evaluate change in proteinuria and the final analysis will be conducted at Week 106 to evaluate eGFR. In addition, approximately 60 participants with eGFR 20-29 mL/min/1.73m2 will be enrolled in an Advanced Kidney Disease (AdKD) Cohort After Week 106, all participants have the option to enter an Open-label Ravulizumab Access Period.

Eligibility

  1. Documentation of IgAN diagnosis established on kidney biopsy obtained any time prior to or during the Screening Period for participants with eGFR greater than or equal to 30 mL/min/1.73 m^2.
  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.
  3. UPCR greater than or equal to 0.75 g/g or UP greater than or equal to 1 g/day calculated from the mean of two 24-hour urine during the Screening Period.
  4. Estimated GFR greater than or equal to 30 mL/min/1.73 m2 at Screening.
  5. Stable and maximum allowed or tolerated RASI (ACEI and/or ARB) dose for greater than or equal to 3 months prior to Screening with no planned change during Screening through Week 106.
  6. Participants who are receiving SGLT2I, DEARA, MRA or ERA must be on a stable and maximum allowed or tolerated dose for greater than or equal to 3 months prior to Screening with no planned change in dose through Week 106.
  1. Diagnosis of rapid progressive glomerulonephritis as measured by eGFR loss greater than or equal to 50% over a period of 3 months prior to Screening.
  2. Secondary IgAN (eg, due to systemic lupus erythematosus (SLE), cirrhosis, or celiac disease; IgAV-N may be eligible).
  3. Concomitant clinically significant renal disease other than IgAN.
  4. Prior use of immunosuppressive treatment within 3 months of screening.
  5. Uncontrolled diabetes mellitus with glycosylated hemoglobin (HbA1c) greater than 8.5%.
  6. Henoch-Schonlein purpura (IgAV) requiring systemic immunosuppressive therapy within 12 months of Screening.
  7. History of kidney transplant or planned kidney transplant during the Treatment Period.
  8. Splenectomy or functional asplenia.
  9. History of Neisseria meningitidis infection.
  10. Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization.
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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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