Fostamatinib in the Treatment of Chronic Active Antibody Mediated Rejection

Sponsor
Imperial College London
Study ID
NCT03991780
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Renal Transplant Rejection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fostamatinib — DRUG
    All patients will be given treatment with Fostamatinib. The initial treatment dose will be 100mg of Fostamatinib twice daily for 8 weeks. If after 8 weeks the participant has not experienced any side effects and are tolerant of this dose, then the dose will increase to 150mg twice daily. This dose will continue for the duration of the study.

Study Details

A Phase 2, Pilot Study to Assess the Safety and Efficacy of Fostamatinib in the Treatment of Chronic Active Antibody Mediated Rejection in Renal Transplantation

Key Dates

Start date
May 8, 2019
Status verified
Nov 2024
Primary completion
Apr 5, 2023
Completion
Oct 15, 2025

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Fostamatinib
    All patients will be given treatment with Fostamatinib. The initial treatment dose will be 100mg of Fostamatinib (tablet taken orally) twice daily for 8 weeks. If after 8 weeks the participant has not experienced any side effects and are tolerant of this dose, then the dose will increase to 150mg twice daily. This dose will continue for the duration of the study.

Primary Outcome Measure

Histological changes of antibody mediated rejection assessed by a histopathologist [ Time Frame: 6 months ]

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