Clazakizumab in Highly-HLA Sensitized Patients Awaiting Renal Transplant
Status:
Active, not recruiting
Trial end date:
2023-12-30
Target enrollment:
Participant gender:
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.