Thymoglobulin in Calcineurin Inhibitor and Steroid Minimization Protocol

University Health Network, Toronto

Status and phase

Unknown

Phase 4

Conditions

Diabetes

Graft Rejection

Treatments

Drug: Thymoglobulin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00706680

07-0619-A

Details and patient eligibility

About

This study has been designed to test whether using Thymoglobulin with low dose Cyclosporine and early steroid dosage reduction will minimize both kidney rejection and the development of new onset diabetes mellitus after renal transplant.

Full description

All patients will receive methyl prednisone intravenously pre-operatively, as per institutional practice. Thymoglobulin will be initiated prior to completion of the anastomosis, or if not possible, within 24 hours of transplantation in all patients and a total dose of 6-7.5mg/kg will be given over 3-5 doses. Steroids will be initiated post-operatively at 1mg/kg/day for 2 days, then 0.5mg/kg/day for 2 days, then 0.25mg/kg/day for 2 days and then patients will be placed on 5mg daily for the remainder of the study. All patients will receive Mycophenolic acid at a dose of 2gm/day (Cellcept) or 1440mg/day (Myfortic) post-transplantation with dose adjustment as needed. Cyclosporine micro-emulsion will be initiated when renal function is established or no later than day 10 in a dose of 3mg/kg twice daily with adjustment to achieve a C2 target of 600-800 nanograms/ml.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

De Novo, single Kidney recipient
At least 1 HLA mismatch

Exclusion criteria

Recipient of multiple organs
prior transplant recipient
Subjects who have Diabetes prior to transplant, as indicated by pre-transplant OGTT
PRA >10%
Hepatitis B surface antigen positive
Hepatitis C antibody positive
HIV positive