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

• Status: Completed
• Trial end date: 2018-11-12
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigel Pharmaceuticals

Criteria

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).