Thymoglobulin in Calcineurin Inhibitor and Steroid Minimization Protocol

Sponsor

University Health Network, Toronto (Other)

Overall Status

Unknown status

CT.gov ID

NCT00706680

Collaborator

Genzyme, a Sanofi Company (Industry), Unity Health Toronto (Other), St. Paul's Hospital, Canada (Other)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Graft Rejection	Drug: Thymoglobulin	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Feb 1, 2008

Anticipated Primary Completion Date :

Feb 1, 2009

Anticipated Study Completion Date :

Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 All subjects meeting the entry criteria will be treated with the study immunosuppressive protocol.	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. Other Names: Thymo Polyclonal ATG Methyl Prednisone SoluMedrol Steroid Prednisone MMF Cell Cept Mycophenolate Mofetil Mycopnlolic Acid Myfortic Cyclosporine Neoral

Arm

Intervention/Treatment

Experimental: 1

All subjects meeting the entry criteria will be treated with the study immunosuppressive protocol.

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.

Other Names:

Thymo

Polyclonal ATG

Methyl Prednisone

SoluMedrol

Steroid

Prednisone

MMF

Cell Cept

Mycophenolate Mofetil

Mycopnlolic Acid

Myfortic

Cyclosporine

Neoral

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of acute rejection [6 months post transplant]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Paul's Hospital	Vancouver	British Columbia	Canada	V6Z 2E8
2	St Michael's Hospital	Toronto	Ontario	Canada	M5C 2T2
3	University health Network	Toronto	Ontario	Canada	M5G 2N2