Evaluation of Cyclosporine Microemulsion and Tacrolimus on the Rate of New Onset Diabetes Mellitus in Kidney Transplantation Recipients
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|ClinicalTrials.gov Identifier: NCT00171496|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : November 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Kidney Transplant||Drug: Cyclosporine microemulsion Drug: Tacrolimus||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||693 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Six-month Open Label, Multicenter, Randomized Study to Evaluate the Incidence of New Onset Diabetes Mellitus and Glucose Metabolism in Patients Receiving Cyclosporine Microemulsion With C-2 Monitoring Versus Tacrolimus After de Novo Kidney Transplantation|
|Study Start Date :||October 2003|
|Actual Primary Completion Date :||March 2006|
|Actual Study Completion Date :||March 2006|
|Experimental: Cyclosporine microemulsion||Drug: Cyclosporine microemulsion|
|Active Comparator: Tacrolimus||Drug: Tacrolimus|
- Incidence of NODM or impaired fasting glucose (IFG) in de novo kidney transplant patients receiving cyclosporine microemulsion versus in patients receiving tacrolimus within the first 6 months post-transplantation.
- Incidence of biopsy-proven acute rejection (BPAR) or graft loss or death within the first 6 months post-transplantation.
- incidence of NODM or IFG within the first 3 mths post-transplantation in pts treated with cyclosporine microemulsion or tacrolimus
- percentage of pts with preexisting diabetes at transplantation who have a glycosylated hemoglobin level >7% at Mths 3 &6 post-transplantation
- Change over time of mean HbA1c at mths 3 &6 post-transplantation in pts w/ preexisting diabetes at transplantation
- percentage of pts who switched from oral hypoglycemic agents to insulin within 3 &6 mths post-transplantation
- incidence of impaired glucose tolerance (IGT) as assessed by an oral glucose tolerance test (OGTT) [ Time Frame: 6 months ]
- Blood pressure at Months 3& 6 post-transplantation
- incidence of BPAR or graft loss or death within the first 3 months post-transplantation, as well as the incidence of each individual event within 3 and 6 months post-transplantation.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171496