CAMPath and BELimumab for Transplant Tolerance in Sensitized Kidney Transplant Recipients

Summary

Participation Requirements

Description

Accrual Objective: Kidney transplant recipients (n=5) will receive standard of care (SOC) therapy consisting of alemtuzumab and steroid induction with mycophenolic acid and tacrolimus maintenance immunosuppression, plus induction and treatment for 6 months with belimumab. Study Design: This is an op...

Accrual Objective: Kidney transplant recipients (n=5) will receive standard of care (SOC) therapy consisting of alemtuzumab and steroid induction with mycophenolic acid and tacrolimus maintenance immunosuppression, plus induction and treatment for 6 months with belimumab. Study Design: This is an open-label pilot-study to evaluate the safety and efficacy of belimumab plus standard of care in the prevention of de novo donor specific antibody in adult subjects after kidney transplantation. The investigators will enroll 5 adult, deceased or living donor kidney transplant recipients who are sensitized, evidenced by: Positive sum Donor Specific Antibody (DSA)<1000 MFI and/or Panel of Reactive Antibodies (PRA)>0%. The primary endpoint of this study is de novo DSA production. There are two main reasons for selecting this patient population for the proposed study. 1) Sensitized patients are known to have higher rates of de novo DSA production and 2) Patients with low levels of DSA (sum DSA<1000 MFI) will enable more fidelity in determining the DSA that is produced de novo. Kidney transplant recipients will receive the standard of care (alemtuzumab and steroid induction with mycophenolic acid and tacrolimus maintenance immunosuppression), plus six months of therapy with belimumab. Belimumab 10 mg/kg will be administered IV for 6 months at the following intervals: Day of transplant (Day 0), and then at Weeks 2, 4, 8, 12, 16, and 20 post-transplant. Study Duration: Subjects will be treated for 6 months with belimumab and followed for DSA production for 1 year. Primary Study Objectives: In this proposal the investigators plan to determine (a) whether the addition of belimumab to the standard of care (SOC: alemtuzumab and steroid induction with mycophenolic acid and tacrolimus maintenance immunosuppression) is safe and effective in preventing de novo DSA production at 1, 3, 6, 9, and 12 months post-transplant. Secondary efficacy endpoints will be 1) graft survival and function as determined by serum creatinine/eGFR and urine protein at 1, 3, 6, 9, and 12 months 2) rates of acute cellular and antibody mediated rejection, at 1, 3, 6, 9, and 12 months. Primary Outcomes: To determine whether the addition of belimumab to the standard of care (SOC: alemtuzumab and steroid induction with mycophenolic acid and tacrolimus maintenance immunosuppression) is safe and effective in preventing de novo DSA production 1, 3, 6, 9, and 12 months. Secondary Outcomes: Secondary endpoints will be 1) graft survival and function as determined by serum creatinine/eGFR and urine protein at 1, 3, 6, 9, and 12 months 2) rates of acute cellular and antibody mediated rejection at 1, 3, 6, 9, and 12 months and 3) the nature, frequency, and severity of serious and non-serious adverse events ?Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.

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