Fostamatinib in the treatment Chronic Antibody Mediated Rejection v1.0
Research type
Research Study
Full title
A Phase 2, Pilot Study to Assess the Safety and Efficacy of Fostamatinib in the Treatment Chronic Active Antibody Mediated Rejection in Renal Transplantation
IRAS ID
235977
Contact name
Frederick Wai Keung Tam
Contact email
Sponsor organisation
Imperial College London
Eudract number
2018-000027-14
Duration of Study in the UK
1 years, 9 months, 1 days
Research summary
Renal transplantation is the treatment of choice for patients with end stage kidney disease (ESKD), offering a better prognosis and quality of life. Despite advances in treatment to prevent acute rejection, kidney transplant survival has not improved over the last few decades, with the average transplant lasting between 8-15 years. Chronic antibody mediated rejection (CAMR) remains the leading cause of transplant failure. It has been estimated that at 5 years post-transplant, 1 in every 5 transplants will have evidence of CAMR and this rate increases over time. We can now effectively diagnose CAMR, however there is no known effective treatment.
Preliminary studies from our centre have shown that biopsies (small samples of transplant taken with a needle) taken from transplant patients experiencing antibody mediated rejection, test positive for a protein called ‘spleen tyrosine kinase’. The presence of this protein in patients with rejection but not in patients without rejection, suggests it is involved in the rejection process. Furthermore, we have shown that the use of a tablet which can stop this protein developing, Fostamatinib, can be successfully used to prevent rejection from occurring in animals. The purpose of the proposed research is to study whether Fostamatinib can be used to treat CAMR. The safety profile of Fostamatinib is well described, with the recent completion of a multicentre randomised controlled trial into its use in IgA glomerulonephritis (a form of inflammation of the kidney), and its prior use in over 3000 patients with rheumatoid arthritis.
We aim to study 10 patients who have had a biopsy because of renal transplant dysfunction which has shown CAMR. All patients will receive a twice daily tablet of Fostamatinib for one year, and will have their transplant function monitored during the treatment period to assess for efficacy.REC name
London - Fulham Research Ethics Committee
REC reference
18/LO/0919
Date of REC Opinion
20 Aug 2018
REC opinion
Further Information Favourable Opinion