Thymoglobulin in Calcineurin Inhibitor and Steroid Minimization Protocol

June 25, 2008 updated by: University Health Network, Toronto

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2E8
        • Not yet recruiting
        • St Paul's Hospital
        • Contact:
          • John Gill
          • Phone Number: 604-681-7191
        • Principal Investigator:
          • John Gill
        • Sub-Investigator:
          • David Landsberg
    • Ontario
      • Toronto, Ontario, Canada, M5G 2N2
        • Recruiting
        • University Health Network
        • Contact:
        • Sub-Investigator:
          • Carl Cardella
        • Principal Investigator:
          • Edward Cole
      • Toronto, Ontario, Canada, M5C 2T2
        • Not yet recruiting
        • St Michael's Hospital
        • Contact:
        • Principal Investigator:
          • Ramesh Prasad
        • Sub-Investigator:
          • Jeffrey Zaltzman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Prednisone
  • Myfortic
  • Cyclosporine
  • MMF
  • Neoral
  • Steroid
  • Mycophenolate Mofetil
  • Cell Cept
  • Thymo
  • Polyclonal ATG
  • Methyl Prednisone
  • SoluMedrol
  • Mycopnlolic Acid

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of acute rejection
Time Frame: 6 months post transplant
6 months post transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Genzyme, a Sanofi Company
Unity Health Toronto
St. Paul's Hospital, Canada

Investigators

  • Study Director: Edward Cole, University Health Network, Toronto
  • Principal Investigator: John Gill, St. Paul's Hospital
  • Principal Investigator: Ramesh Prasad, Unity Health Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Anticipated)

February 1, 2009

Study Completion (Anticipated)

June 1, 2009

Study Registration Dates

First Submitted

February 8, 2008

First Submitted That Met QC Criteria

June 25, 2008

First Posted (Estimate)

June 27, 2008

Study Record Updates

Last Update Posted (Estimate)

June 27, 2008

Last Update Submitted That Met QC Criteria

June 25, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-0619-A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes

Clinical Trials on Thymoglobulin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe