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Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) Nephropathy
Not Recruiting
Trial ID: NCT02112838
Purpose
The purpose of this study is to determine whether fostamatinib is safe and effective in the
treatment of IgA Nephropathy
Official Title
A Phase 2, Multi-Center, Randomised, Double-Blind, Ascending-Dose, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of Fostamatinib in the Treatment of IgA Nephropathy
Stanford Investigator(s)
Richard Lafayette
Professor of Medicine (Nephrology)
Eligibility
Inclusion Criteria:
- Renal biopsy findings consistent with IgA nephropathy
- Treatment with an Angiotensin Converting Enzyme inhibitor (ACEi) and/or an Angiotensin
II Receptor Blocker (ARB) for at least 90 days at the maximum approved (or tolerated)
dose
- Proteinuria > 1 gm/day at diagnosis of IgA nephropathy and Proteinuria > 0.50 gm/day
at the second Screening Visit
- Blood pressure controlled to ≤ 130/80 with angiotensin blockade with or without other
anti-hypertensive agents
Exclusion Criteria:
- Recent use of cyclophosphamide, mycophenolate mofetil, azathioprine, or Rituximab.
- Use of > 15 mg/day prednisone (or other corticosteroid equivalent).
Intervention(s):
drug: Fostamatinib 150 mg
drug: Fostamatinib 100 mg
drug: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Richard Lafayette, MD
650-498-6063