Thymoglobulin in Calcineurin Inhibitor and Steroid Minimization Protocol

Diabetes Clinical Trial

Official title:

The Use of Thymoglobulin in a Calcineurin Inhibitor and Steroid Minimization Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00706680
• Other study ID #: 07-0619-A
• Status: Recruiting
• Phase: Phase 4
• First received: February 8, 2008
• Last updated: June 25, 2008
• Start date: February 2008
• Est. completion date: June 2009

Study information

• Verified date: February 2008
• Source: University Health Network, Toronto
• Contact: Edward Cole
• Phone: 416-340-4800
• Email: edward.cole[@]uhn.on.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes
• Graft Rejection

Intervention

Drug:
• Thymoglobulin
methyl prednisone intravenously pre-operatively, as per institutional practice. Thymoglobulin, initiated prior to completion of the anastomosis, or if not possible, within 24 hours of transplantation for a total dose of 6-7.5mg/kg given over 3-5 doses. Steroids 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. 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.

Locations

Country	Name	City	State
Canada	St Michael's Hospital	Toronto	Ontario
Canada	University health Network	Toronto	Ontario
Canada	St Paul's Hospital	Vancouver	British Columbia

Sponsors (4)

Lead Sponsor	Collaborator
University Health Network, Toronto	Genzyme, a Sanofi Company, St. Michael's Hospital, Toronto, St. Paul's Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients developing New Onset Diabetes post transplant, as identified by an oral glucose tolerance test		6 months post transplant.	Yes
Secondary	Incidence of acute rejection		6 months post transplant	Yes