Clazakizumab for Kidney Transplant Rejection

Recruiting in Palo Alto (17 mi)

Overseen byStanley Jordan, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Stanley Jordan, MD

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for highly-HLA sensitized patients aged 15-75 awaiting a kidney transplant, who have had previous allograft failure, pregnancies, transfusions or transplants. They must be on the UNOS list with a cPRA≥50%, vaccinated against pneumococcus and TB-free. It excludes those intolerant to IL-6 inhibitors, pregnant or lactating women, HIV/HBV/HCV positive individuals, recent live vaccine recipients and those with certain infections or malignancies.

Inclusion Criteria

I am a highly sensitized patient waiting for a kidney transplant.

I am between 15 and 75 years old.

I have had pregnancies, blood transfusions, or a kidney transplant.

+4 more

Exclusion Criteria

I cannot tolerate clazakizumab or similar medications.

I have tested positive for hepatitis B or C.

I have an active CMV or EBV infection confirmed by blood tests.

+12 more

Participant Groups

The study tests Clazakizumab in patients needing desensitization before a kidney transplant. Participants will receive up to six monthly pre-transplant doses of Clazakizumab (25 mg), continuing post-transplant if successful. The treatment aims to improve chances of receiving an HLA incompatible renal transplant and reduce rejection.

1Treatment groups

Experimental Treatment

Group I: ClazakizumabExperimental Treatment1 Intervention

All twenty patients will receive clazakizumab monthly. Patients will receive up to 6 doses pre-transplantation. If patients are transplanted during the study, they will then receive 6 doses of clazakizumab (monthly) and a 6 month protocol biopsy will be performed. Based on the biopsy results and clinical labs PI will determine if patients should continue monthly doses for up to another 6 doses and day 330 post-transplantation. Patients who received 12 post-transplant doses of clazakizumab will then undergo a 12 month protocol biopsy.