Thymoglobulin in Calcineurin Inhibitor and Steroid Minimization Protocol

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Diabetes; Graft Rejection	Drug: Thymoglobulin	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	30 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	The Use of Thymoglobulin in a Calcineurin Inhibitor and Steroid Minimization Protocol
Study Start Date :	February 2008
Estimated Primary Completion Date :	February 2009
Estimated Study Completion Date :	June 2009

Arms and Interventions

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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: Thymo; Polyclonal ATG; Methyl Prednisone; SoluMedrol; Steroid; Prednisone; MMF; Cell Cept; Mycophenolate Mofetil; Mycopnlolic Acid; Myfortic; Cyclosporine; Neoral

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Incidence of acute rejection [ Time Frame: 6 months post transplant ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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
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

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Dr. Edward Cole, University Health Network
ClinicalTrials.gov Identifier:	NCT00706680 History of Changes
Other Study ID Numbers:	07-0619-A
First Posted:	June 27, 2008
Last Update Posted:	June 27, 2008
Last Verified:	February 2008

Additional relevant MeSH terms:

Prednisone; Mycophenolic Acid; Cyclosporins; Cyclosporine; Thymoglobulin; Antilymphocyte Serum; Calcineurin Inhibitors; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal	Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Antifungal Agents; Anti-Infective Agents; Dermatologic Agents; Antirheumatic Agents; Antibiotics, Antineoplastic; Antibiotics, Antitubercular; Antitubercular Agents; Anti-Bacterial Agents