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

Status:	Completed
Conditions:	Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:	Nephrology / Urology
Healthy:	No
Age Range:	18 - 70
Updated:	1/20/2019
Start Date:	October 2014
End Date:	November 12, 2018

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).

We found this trial at

sites

Southeast Renal Research Institute

Chattanooga, Tennessee 37404

Principal Investigator: James Tumlin, MD

Phone: 423-648-7697

from

Chattanooga, TN