Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) Nephropathy

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

The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of IgA Nephropathy

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).