Clazakizumab in Highly-HLA Sensitized Patients Awaiting Renal Transplant

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Kidney Failure, Chronic, End-Stage Renal Disease, Transplant Glomerulopathy, Transplant;Failure,Kidney, Kidney Transplant Failure and Rejection, Antibody-mediated Rejection, Kidney Transplant; Complications

In brief

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.

Key facts

Study ID

NCT03380962

Run by

Stanley Jordan, MD

People needed

20

Starts

2018-02-27

Expected to finish

2025-08-30

Last updated by the study team

2025-03-24

Who can join

Age: 15 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Multi-organ transplant (e.g. kidney and pancreas)
• Intolerability to clazakizumab or other IL-6 inhibitor therapies
• Lactating or pregnant females.
• 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
• A significantly abnormal general serum screening lab result defined as a ANC <2000, platelet count < 100 X 103/ml, an SGOT or SGPT > 1.5X upper limit normal.
• Individuals deemed unable to comply with the protocol.
• Subjects with active CMV or EBV infection as defined by CMV-specific serology (IgG or IgM) and confirmed by quantitative PCR with or without a compatible illness.
• Use of investigational agents within 4 weeks of participation.
• History or active Inflammatory Bowel Disease or Diverticular Disease or gastrointestinal perforation
• Recent infection (within past 6 weeks of screening) requiring any antibiotic use (oral, parenteral or topical).
• Present or previous (within 5 years) malignancy except for basal cell carcinoma, fully excised squamous cell carcinoma of the skin or non-recurrent (within 5 years) cervical carcinoma-in-situ

Where it is running

• Norko Ammerman — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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