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

Trial ID or NCT#

NCT02112838

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: 18 to 70
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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
    1. Exclusion Criteria:
  2. * Recent use of cyclophosphamide, mycophenolate mofetil, azathioprine, or Rituximab.* Use of \> 15 mg/day prednisone (or other corticosteroid equivalent).
Exclusion Criteria:
  1. * Recent use of cyclophosphamide, mycophenolate mofetil, azathioprine, or Rituximab.* Use of \> 15 mg/day prednisone (or other corticosteroid equivalent).
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Contact us to find out if this trial is right for you.

Contact

Richard Lafayette, MD
650-498-6063

View on ClinicalTrials.gov