Clinical trial NCT00706680: Thymoglobulin in Calcineurin Inhibitor and Steroid Minimization Protocol
Official title: The Use of Thymoglobulin in a Calcineurin Inhibitor and Steroid Minimization Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes
Graft Rejection
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
name: Unity Health Toronto
name: St. Paul's Hospital, Canada
First posted: 2008-06-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients developing New Onset Diabetes post transplant, as identified by an oral glucose tolerance test
timeFrame: 6 months post transplant.
Secondary outcomes:
measure: Incidence of acute rejection
timeFrame: 6 months post transplant
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St Paul's Hospital
state: British Columbia
city: Toronto
country: Canada
facility: St Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: University health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Edward Cole
role: STUDY_DIRECTOR
affiliation: St. Paul's Hospital
name: John Gill
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: Ramesh Prasad
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cole EH, Prasad GV, Cardella CJ, Kim JS, Tinckam KJ, Cattran DC, Schiff JR, Landsberg DN, Zaltzman JS, Gill JS. A pilot study of reduced dose cyclosporine and corticosteroids to reduce new onset diabetes mellitus and acute rejection in kidney transplant recipients. Transplant Res. 2013 Jan 12;2(1):1. doi: 10.1186/2047-1440-2-1.