Thymoglobulin in Calcineurin Inhibitor and Steroid Minimization Protocol

Phase 4

• Conditions: Diabetes; Graft Rejection
• Interventions: Drug: Thymoglobulin

• Registration Number: NCT00706680
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2008-02
• Study Start: 2008-02
• Study First Submitted: 2008-02-08
• Study First Submitted QC: 2008-06-25
• Last Update Submitted: 2008-06-25
• Study First Posted: 2008-06-27
• Last Update Posted: 2008-06-27
• Primary Completion: 2009-02
• Study Completion: 2009-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Thymoglobulin	All subjects meeting the entry criteria will be treated with the study immunosuppressive protocol.

Primary Outcome Measures

Name	Time	Method
Percentage of patients developing New Onset Diabetes post transplant, as identified by an oral glucose tolerance test	6 months post transplant.

Secondary Outcome Measures

Name	Time	Method
Incidence of acute rejection	6 months post transplant

Trial Locations

Locations (3)

University health Network; 🇨🇦 Toronto, Ontario, Canada

St Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

St Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada