A Safety Study of Tocilizumab to Improve Transplant Rates in Highly Sensitized Patients Awaiting Kidney Transplantation
Status:
Completed
Trial end date:
2015-05-01
Target enrollment:
Participant gender:
Summary
In this Phase I/II trial, 10 highly sensitized patients will be entered after informed
consent and will receive Intravenous Immunoglobulin (IVIG) at 2 gm/kg + Tocilizumab 8 mg/kg x
5 doses on days 15, 45, 75, 105, 119, 135, and 149. If robust reductions in anti-HLA antibody
are seen, patients will progress to kidney transplantation when an "acceptable" crossmatch is
achieved with a living donor (LD) or deceased donor (DD). Those receiving transplants will
also receive Tocilizumab infusion monthly X7 doses post-transplant. All subjects will have
intensive monitoring of Donor Specific Antibodies (DSA), viral PCRs, and routine
post-transplant labs. At 6 months post-transplant, those who have retained their transplanted
kidney will have a protocol biopsy.