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| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | July 21, 2008 | ||||
| Start Date ICMJE | October 2004 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00171496 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluation of Cyclosporine Microemulsion and Tacrolimus on the Rate of New Onset Diabetes Mellitus in Kidney Transplantation Recipients | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | The purpose of this study is to evaluate the impact of tacrolimus and cyclosporine microemulsion on glucose metabolism in kidney transplant recipients and the efficacy and safety in preventing organ rejection |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Kidney Transplant | ||||
| Intervention ICMJE | Drug: Cyclosporine microemulsion; Tacrolimus | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 702 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria: - First or second transplant, cadaveric or living donor Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria applied |
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | |||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00171496 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | COLO400A2419 | ||||
| Study Sponsor ICMJE | Novartis | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Novartis | ||||
| Verification Date | July 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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