Recruiting

Thymoglobulin with CNI & Steroids

Sponsor:

University Health Network, Toronto

Code:

NCT00706680

Conditions

Diabetes

Graft Rejection

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Thymoglobulin

Study Details

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.

Conditions

Diabetes

Graft Rejection

Study ID

NCT00706680

Start date

Feb, 2008

Status verified date

Feb, 2008

Completion date

Jun, 2009

Anticipated

Primary completion date

Feb, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 1

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

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Edward Cole

416-340-4800edward.cole@uhn.on.ca

Bricio Rodriguez

416-340-4800bricio.rodriguez@uhn.on.ca

Locations

University health Network

Recruiting

Toronto, Ontario, Canada, M5G 2N2

Contacts

Bricio Rodriguez

416-340-4800bricio.rodriguez@uhn.on.ca

Principal Investigator:

Edward Cole

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jun 27, 2008

Last verified

Feb, 2008

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2008-06-27.