Conditions: End Stage Renal Disease (ESRD)
Keywords: Donor-Specific Anti-HLA Antibodies Kidney Transplantation
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 10
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Tocilizumab intervention 2: Intravenous Immunoglobulin
Intervention descriptions: intervention 1: Tocilizumab 8mg/kg on Days 0, 15, 30, 45, 75, 105, 119, 135, 149, and 180 intervention 2: All HS who meet criteria for desensitization will receive IVIG 10% (2.0 g/kg \[maximum 140 g per dose\] on days 1 and 30).

Protocol document: