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

Completed · Phase 2 · Has a placebo group

Conditions studied: IGA Nephropathy

In brief

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

Key facts

Study ID

NCT02112838

Run by

Rigel Pharmaceuticals

People needed

76

Starts

2014-10-01

Expected to finish

2018-11-12

Last updated by the study team

2019-06-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Recent use of cyclophosphamide, mycophenolate mofetil, azathioprine, or Rituximab.
• Use of > 15 mg/day prednisone (or other corticosteroid equivalent).

Where it is running

• Stanford University Medical — Palo Alto, California, United States
• Nephrology Associates PC, University Hospital, Professional Center 1 — Augusta, Georgia, United States
• Ohio State University — Columbus, Ohio, United States
• Southeast Renal Research Institute — Chattanooga, Tennessee, United States
• Medical University of Graz — Graz, Styria, Austria
• Medical University Vienna, Nephrology — Vienna, Austria
• Medical University of Heidelberg — Heidelberg, Baden-Wurtemberberg, Germany
• Klinikum der Universität München — Munich, Bavaria, Germany
• Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden — Dresden, Saxony, Germany
• Medical University of Jena — Jena, Thuringia, Germany
• Prince of Wales Hospital — Hong Kong, Sha Tin, Hong Kong
• Queen Mary Hospital — Hong Kong, Hong Kong
• China Medical University Hospital — Taichung, Taiwan
• School of Medicine, Chang Gung University, Chang Gung Memorial Hospital — Taoyuan, Taiwan
• Addenbrookes Hospital — Cambridge, United Kingdom
• Cardiff University — Cardiff, United Kingdom
• Leicester General Hospital — Leicester, United Kingdom
• Royal Free Hospital — London, United Kingdom
• Hammersmith Hospital — London, United Kingdom
• Freeman Hospital — Newcastle upon Tyne, United Kingdom

Full record on ClinicalTrials.gov

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