Belatacept in Kidney Transplantation of Moderately Sensitized Patients

PHASE4WithdrawnINTERVENTIONAL
0
Timeline

Start Date

September 24, 2014

Primary Completion Date

October 9, 2015

Study Completion Date

October 9, 2015

Conditions
End Stage Renal DiseaseAntibody Mediated Rejection
Interventions
DRUG

Belatacept

Belatacept will be added to the standard of care regimen and will be given at days 0,5, weeks 2, 4, 8 and 12 (10 mg/kg) and every 4 weeks (5 mg/kg) for one year.

DRUG

Tacrolimus withdrawal

Tacrolimus dosing will begin on Days 1 through 5 post transplant at up to 2 mg BID to achieve target trough levels of 9-11 ng/ml. The dose will be tapered through the end of week 2 to achieve a trough level of 4 ng/ml which will be maintained for six weeks. Tacrolimus will be withdrawn at the end of eight weeks post transplant.

PROCEDURE

Plasmapheresis/Intravenous Immunoglobulin G

Enrolled patients will start with standard of practice treatment including plasmapheresis and IVIG therapy twice after transplant, on days 2 and 4 and potentially once before transplant. Plasmapheresis and albumin exchange for one volume of blood will be performed in the infusion center at the University of Wisconsin Hospital and Clinics (UWHC). Each pheresis session will be completed by IVIG infusion. While plasmapheresis will help with the removal of circulating Donor Specific Antibodies (DSA), IVIG therapy will provide immunomodulatory characteristics that include sterilizing immunity from infections, inhibiting and scavenging activated complement fragments, modifying cell-mediated immune responses, inducing regulatory T cells and importantly, inhibiting deleterious antibody production.

DRUG

Thymoglobulin (ATG)

Thymoglobulin (ATG) Induction. Thymoglobulin will be administered to a total cumulative dose of 4.5-6 mg/kg via a peripheral or central vein, starting in the operating room.

DRUG

Myfortic

Patients will receive 720mg bid of Myfortic throughout the study, starting day 1 after surgery.

DRUG

Steroids

Patients will receive Dexamethasone IV on the day of surgery (Day 0) with tapered doses through Day 4 followed by prednisone tapered to 10mg/d by day 30.,

Trial Locations (1)

53792

University of Wiscsonsin Hospital and Clinics, Madison

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

University of Wisconsin, Madison

OTHER