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Thymoglobulin in Calcineurin Inhibitor and Steroid Minimization Protocol
This study is currently recruiting participants.
Verified by University Health Network, Toronto, February 2008
Sponsors and Collaborators: University Health Network, Toronto
Genzyme
St. Michael's Hospital, Toronto
St. Paul's Hospital, Canada
Information provided by: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00706680
  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 IV

MedlinePlus related topics: Diabetes
Drug Information available for: Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate Prednisone Cyclosporin Cyclosporine Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Mycophenolic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: The Use of Thymoglobulin in a Calcineurin Inhibitor and Steroid Minimization Protocol

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
1: Experimental
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.

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
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
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

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

Study placed in the following topic categories:
Prednisone
Cyclosporine
Methylprednisolone
Prednisolone
Mycophenolate mofetil
Mycophenolic Acid
Diabetes Mellitus
Methylprednisolone acetate
Prednisolone acetate
Cyclosporins
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Immunosuppressive Agents
Glucocorticoids
Hormones
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009