Clazakizumab in Highly-HLA Sensitized Patients Awaiting Renal Transplant

Launched by STANLEY JORDAN, MD · Dec 20, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a medication called clazakizumab to help patients who are highly sensitized and waiting for a kidney transplant. These patients have had previous transplant failures and need special treatment to make it possible for them to receive another kidney. The study will enroll up to twenty people aged 15 to 75 who have a specific level of sensitization (known as cPRA ≥ 50%). Participants will receive up to six doses of clazakizumab before their transplant, and if they successfully receive a transplant, they will continue to receive more doses after the procedure.

To be eligible for the trial, participants must be on the transplant waiting list and have a history of pregnancies, blood transfusions, or past kidney transplants. They must also be vaccinated against pneumonia and not have certain infections or health issues. Throughout the trial, patients will have regular check-ups to monitor their health and kidney function. This study is important because it may offer hope to patients who face challenges in receiving a kidney transplant due to their sensitization levels.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 15-75 years at the time of screening.
• • 2. HS patients (cPRA≥50%) awaiting DD or LD kidney transplant on the UNOS list.
• • 3. Previous history of pregnancies, blood transfusion and/or renal transplant.
• • 4. Subject/Parent/Guardian must be willing to participate fully with study requirements.
• • 5. Subject/Parent/Guardian must be able to understand and provide informed consent.
• • 6. Pneumococcal vaccinated
• • 7. Negative Tuberculin (ppd) placement result or negative Quantiferon TB gold results
• Exclusion Criteria:
• • 1. Multi-organ transplant (e.g. kidney and pancreas)
• • 2. Intolerability to clazakizumab or other IL-6 inhibitor therapies
• • 3. Lactating or pregnant females.
• • 4. 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.
• • 5. HIV-positive subjects.
• • 6. Subjects who test positive for HBV by HBVeAg/DNA or HCV infection \[positive Anti-HCV (EIA) and confirmatory HCV RIBA\].
• • 7. Subjects with latent or active TB. Subjects must have negative Quantiferon TB gold test result.
• • 8. Recent recipients of any licensed or investigational live attenuated vaccine(s) within two months of the screening visit
• • 9. 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.
• • 10. Individuals deemed unable to comply with the protocol.
• • 11. 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.
• • 12. Use of investigational agents within 4 weeks of participation.
• • 13. History or active Inflammatory Bowel Disease or Diverticular Disease or gastrointestinal perforation
• • 14. Recent infection (within past 6 weeks of screening) requiring any antibiotic use (oral, parenteral or topical).
• • 15. 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