Status:
COMPLETED
Clazakizumab for Chronic and Active Antibody Mediated Rejection Post-Kidney Transplant
Lead Sponsor:
Stanley Jordan, MD
Conditions:
Antibody-mediated Rejection
Kidney Transplant; Complications
Eligibility:
All Genders
15-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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 t...
Detailed Description
This is a single center, Phase I/II, open label single-arm exploratory study. The trial will primarily examine the safety and tolerability of clazakizumab given after the diagnosis of cABMR in 10 subj...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
February 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 16 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03380377
Start Date
February 21 2018
End Date
April 16 2024
Last Update
May 6 2025
Active Locations (1)
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1
Norko Ammerman
Los Angeles, California, United States, 90048