Status:
TERMINATED
Safety and Efficacy of Converting Maintenance Kidney and Liver Transplant Recipients With Abnormal Glucose Metabolism From Tacrolimus to Cyclosporine Micro-emulsion
Lead Sponsor:
Novartis
Conditions:
Tacrolimus-associated Abnormal Glucose Metabolism in Kidney and Liver Transplant Recipients
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
New onset diabetes mellitus (NODM) post- transplantation decreases patient and graft survival. Some immunosuppressive agents are associated with a higher incidence of NODM. This study evaluates the sa...
Eligibility Criteria
Inclusion
- Recipients of first or second cadaveric or living donor kidney transplantation or first cadaveric or living donor liver transplantation
- Receiving tacrolimus as a primary immunosuppressant
- Currently on any diabetic agent or meets the American Diabetes Association definition of diabetes mellitus
Exclusion
- History of treated diabetes mellitus prior to transplantation
- Less than 2 weeks post-transplantation for kidney and less than 8 weeks for liver
- Greater than 36 months post-transplantation
- Onset of diabetes is greater than 12 months prior to time of study entry
- Has unacceptable or unstable graft function
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00150085
Start Date
February 1 2004
End Date
October 1 2005
Last Update
February 18 2011
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