Phase 2 Study of Fostamatinib for Subjects with IgA Nephropathy
Research type
Research Study
Full title
A Phase 2, Multi-Center, Randomized, Double-Blind, Ascending-Dose, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of Fostamatinib in the Treatment of IgA Nephropathy
IRAS ID
156211
Contact name
Frederick Wai Keung Tam
Contact email
Sponsor organisation
Rigel Pharmaceuticals Inc
Eudract number
2014-000331-16
Clinicaltrials.gov Identifier
Research summary
The purpose of this randomized, placebo-controlled, dose escalation study is to assess the efficacy and safety of fostamatinib, an oral spleen tyrosine kinase (Syk) inhibitor, in patients with IgA nephropathy (IgAN). IgAN is a chronic kidney disease that develops when antibodies called IgA1 deposit in the kidney tissue, resulting in inflammation and impairment of kidney function. The purpose of this research study is to see how effective fostamatinib is at reducing the amount of protein in the urine, decreasing inflammation in the kidney, and improving kidney function.
This study will involve up to 75 adult patients with IgAN . Approximately 25 different research centres from the UK, Austria, Germany, Switzerland, Hong Kong, Singapore, and Taiwan will participate. The duration of the study will be from 27 to 51 weeks (up to 180 days for screening, 24 weeks of treatment, and 1 week for follow-up). Subjects will be asked to visit the clinic 11 times during the study. Blood and urine samples will be collected from the subject throughout the study and 1 kidney biopsy will be taken after dosing of study drug has been completed.
REC name
London - Fulham Research Ethics Committee
REC reference
14/LO/0865
Date of REC Opinion
28 Jul 2014
REC opinion
Further Information Favourable Opinion