Not Signed In -
Tacrolimus |
FK 506; Prograf |
Clinical Trial: Safety and Efficacy of Converting Maintenance Kidney and Liver Transplant Recipients with Abnormal Glucose Metabolism from Tacrolimus to Cyclosporine Micro-Emulsion
This study is no longer recruiting patients.
|
Purpose
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 safety and efficacy of converting patients with NODM from tacrolimus to cyclosporine micro-emulsion as a primary immunosuppressant for kidney and liver recipients.
| Condition | Intervention | Phase |
|---|---|---|
| Tacrolimus-associated abnormal glucose metabolism in kidney and liver transplant recipients | Drug: cyclosporine micro-emulsion | Phase IV |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Prospective, Randomized, Open-Label, Twenty-Six Week Study of the Efficacy and Safety of Converting Kidney and Liver Transplant Recipients with Tacrolimus-Associated Abnormal Glucose Metabolism to Cyclosporine Micro-Emulsion with C2 Monitoring
Further Study Details:
Study start: February 2004
Eligibility
Ages Eligible for Study: 18 Years - 75 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Location Information
Study chairs or principal investigators
Novartis, Study Director, Novartis
More Information
Study ID Numbers: COLO400AUS06
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00150085
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00150085
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13
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