Clazakizumab in Highly-HLA Sensitized Patients Awaiting Renal Transplant
United States20 participantsStarted 2018-02-27
Plain-language summary
Patients who have had a previous allograft failure represent a major problem for transplant centers as they are highly-human leukocyte antigen (HLA) sensitized and unlikely to receive another transplant without significant desensitization. This single center, phase I/II, open label single-arm exploratory study focuses on enrolling twenty patients (ages 15-75) who will begin desensitization therapy to achieve HLA incompatible (HLAi) renal transplantation. Patients who qualify will receive up to 6 doses of clazakizumab 25 mg monthly pre-transplantation. If patients receive an HLAi transplant during the study, the participants will continue to receive another 6 monthly doses of clazakizumab 25 mg, followed by a 6 month protocol biopsy. Patients will continue another 6 doses over 6 months if improvements are seen after the 6th dose of clazakizumab. Patients who develop evidence of persistent allograft dysfunction may have non-protocol biopsies for cause. Patients who receive 12 doses of clazakizumab post-transplant will receive a 12M protocol biopsy.
Who can participate
Age range15 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age 15-75 years at the time of screening.
✓. HS patients (cPRA≥50%) awaiting DD or LD kidney transplant on the UNOS list.
✓. Previous history of pregnancies, blood transfusion and/or renal transplant.
✓. Subject/Parent/Guardian must be willing to participate fully with study requirements.
✓. Subject/Parent/Guardian must be able to understand and provide informed consent.
✓. Pneumococcal vaccinated
✓. Negative Tuberculin (ppd) placement result or negative Quantiferon TB gold results
Exclusion criteria
✕. Multi-organ transplant (e.g. kidney and pancreas)
✕. Intolerability to clazakizumab or other IL-6 inhibitor therapies
✕. Lactating or pregnant females.
What they're measuring
1
Change in donor specific antibodies
Timeframe: Up to 21 months
2
Incidence of treatment related adverse effects of clazakizumab therapy
. Women of child-bearing age and male partners of 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.
✕. HIV-positive subjects.
✕. Subjects who test positive for HBV by HBVeAg/DNA or HCV infection \[positive Anti-HCV (EIA) and confirmatory HCV RIBA\].
✕. Subjects with latent or active TB. Subjects must have negative Quantiferon TB gold test result.
✕. Recent recipients of any licensed or investigational live attenuated vaccine(s) within two months of the screening visit