Clazakizumab for Chronic and Active Antibody Mediated Rejection Post-Kidney Transplant (NCT03380377) | Clinical Trial Compass
CompletedPhase 1/2
Clazakizumab for Chronic and Active Antibody Mediated Rejection Post-Kidney Transplant
United States10 participantsStarted 2018-02-21
Plain-language summary
Antibody mediated rejection (ABMR) is a unique, significant and often severe form of allograft rejection. This single center, phase I/II, open label single-arm exploratory study focuses on enrolling ten patients with biopsy proven chronic antibody medicated rejection and/or donor specific antibody present at time of biopsy. Patients who qualify will be receiving clazakizumab (anti-IL6 monoclonal antibody) monthly x six doses. A protocol biopsy will be performed at 6 months and if improvement is seen, patients will continue another six doses for up to 12 months. For those completing 12 doses, there will be a 12 month protocol biopsy. For those who only received six doses, the next and last study visit will be at 12 months from enrollment. Total study duration is 12 months.
Who can participate
Age range15 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age 15-75 years at the time of screening.
✓. Biopsy proven cABMR with TG on biopsy as defined by Banff 2015 and DSA positive at time of biopsy
✓. Subject/Parent/Guardian must be able to understand and provide informed consent.
✓. Pneumococcal vaccinated
✓. Negative tuberculin ppd result or negative Quantiferon TB gold
Exclusion criteria
✕. Multi-organ transplant (e.g. kidney and pancreas)
✕. eGFR \< 30 mL/min/1.73m2
✕. Advanced Transplant Glomerulopathy (CG3)
✕. Previous allergic reactions to monoclonal antibodies.
✕. Lactating or pregnant females.
✕. Women of child-bearing age who are not willing or able to practice FDA-approved forms of contraception during study and for 5 months after last dose.
What they're measuring
1
Number of Participants With Donor Specific Antibody (DSA) Elimination or Reduction Based on Luminex HLA Testing
Timeframe: 12 months
2
Number of Participants With Stabilization of Clinical Features of cABMR Via BANFF Biopsy Grading Criteria.