Thymoglobulin in Calcineurin Inhibitor and Steroid Minimization Protocol

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Genzyme, a Sanofi Company
St. Michael's Hospital, Toronto
St. Paul's Hospital, Canada
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00706680
First received: February 8, 2008
Last updated: June 25, 2008
Last verified: February 2008
  Purpose

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 Intervention Phase
Diabetes
Graft Rejection
Drug: Thymoglobulin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Use of Thymoglobulin in a Calcineurin Inhibitor and Steroid Minimization Protocol

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Percentage of patients developing New Onset Diabetes post transplant, as identified by an oral glucose tolerance test [ Time Frame: 6 months post transplant. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of acute rejection [ Time Frame: 6 months post transplant ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: February 2008
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706680

Contacts
Contact: Edward Cole 416-340-4800 ext 4669 edward.cole@uhn.on.ca
Contact: Bricio Rodriguez 416-340-4800 ext 5921 bricio.rodriguez@uhn.on.ca

Locations
Canada, British Columbia
St Paul's Hospital Not yet recruiting
Vancouver, British Columbia, Canada, V6Z 2E8
Contact: John Gill    604-681-7191      
Principal Investigator: John Gill         
Sub-Investigator: David Landsberg         
Canada, Ontario
University health Network Recruiting
Toronto, Ontario, Canada, M5G 2N2
Contact: Bricio Rodriguez    416-340-4800 ext 5921    bricio.rodriguez@uhn.on.ca   
Sub-Investigator: Carl Cardella         
Principal Investigator: Edward Cole         
St Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5C 2T2
Contact: Ramesh Prasad    (416) 867-3722    Ramesh.Prasad@utoronto.ca   
Principal Investigator: Ramesh Prasad         
Sub-Investigator: Jeffrey Zaltzman         
Sponsors and Collaborators
University Health Network, Toronto
Genzyme, a Sanofi Company
St. Michael's Hospital, 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 St. Michael's Hospital, Toronto
  More Information

No publications provided

Responsible Party: Dr. Edward Cole, University Health Network
ClinicalTrials.gov Identifier: NCT00706680     History of Changes
Other Study ID Numbers: 07-0619-A
Study First Received: February 8, 2008
Last Updated: June 25, 2008
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Mycophenolic Acid
Mycophenolate mofetil
Methylprednisolone Hemisuccinate
Prednisone
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Anti-Inflammatory Agents
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on July 20, 2014