Status:
ACTIVE_NOT_RECRUITING
Clazakizumab in Highly-HLA Sensitized Patients Awaiting Renal Transplant
Lead Sponsor:
Stanley Jordan, MD
Conditions:
Kidney Failure, Chronic
End-Stage Renal Disease
Eligibility:
All Genders
15-75 years
Phase:
PHASE1
PHASE2
Brief 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 transpla...
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 consented and eligible patients b...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03380962
Start Date
February 27 2018
End Date
August 30 2025
Last Update
March 24 2025
Active Locations (1)
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1
Norko Ammerman
Los Angeles, California, United States, 90048