Clazakizumab for Chronic and Active Antibody Mediated Rejection Post-Kidney Transplant

Completed · Phase 1/Phase 2

Conditions studied: Antibody-mediated Rejection, Kidney Transplant; Complications, Transplant Glomerulopathy, Transplant Glomerulopathy - Late Form, Transplant Glomerulopathy - Early Form, Kidney Transplant Rejection

In brief

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.

Key facts

Study ID

NCT03380377

Run by

Stanley Jordan, MD

People needed

10

Starts

2018-02-21

Expected to finish

2024-04-16

Last updated by the study team

2025-05-06

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.
• 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

You may not qualify if…

• 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.
• 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 j) A significantly abnormal general serum screening lab result defined as a WBC < 3.0 X 103/ml, a Hgb < 8.0 g/dL, a platelet count < 100 X 103/ml, an SGOT or SGPT > 3X 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

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.