Fostamatinib in the Treatment of Chronic Active Antibody Mediated Rejection (NCT03991780) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Fostamatinib in the Treatment of Chronic Active Antibody Mediated Rejection
United Kingdom8 participantsStarted 2019-05-08
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Signed informed consent prior to any study specific screening procedures.
* Male or female, at least 18 years of age
* Females must be either post-menopausal, surgically sterile (hysterectomy, bilateral salpingectomy or bilateral oophorectomy), or, if of child-bearing potential, must not be pregnant or lactating.
* Patients must be established on tacrolimus maintenance immunosuppression
* A pre-study renal biopsy obtained within 3 months prior to Baseline (Visit 1) will be reviewed by a renal pathologist to ensure subjects meet the following Banff histologic entry criteria: If C4d positive: Microcirculation inflammation score (g+ptc) ≥1 If C4d negative: Microcirculation inflammation score (g+ptc) ≥2 Chronic glomerulopathy (cg) score ≥1b or significant Peritubular Capillary Basement Membrane Multilayering (PTCBML) Chronic tubulo-interstitial scarring ≤50% Glomerular global obsolescence ≤50% Sample must contain at least 7 glomeruli and 1 artery
* Otherwise in stable health as determined by the Investigator based on medical history and laboratory tests during the screening period. See Exclusion Criteria for specific exclusions.
* In the Investigator's opinion, understand the duration of the study (up to 52 weeks), including the requirements for renal biopsies, and has the ability to understand the nature of the study and any hazards of participation and to communicate satisfactorily with the Investigator.
Exclusion Criteria:
* Co-existing Banff Category 4…
What they're measuring
1
Histological changes of antibody mediated rejection assessed by a histopathologist