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Sponsored by: |
Novartis |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00171496 |
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
Condition | Intervention | Phase |
---|---|---|
Kidney Transplant |
Drug: Cyclosporine microemulsion; Tacrolimus |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 702 |
Study Start Date: | October 2004 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
- First or second transplant, cadaveric or living donor
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria applied
Study ID Numbers: | COLO400A2419 |
Study First Received: | September 12, 2005 |
Last Updated: | July 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00171496 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Kidney transplant, adults, new onset diabetes mellitus, immunosuppressants |
Cyclosporine Metabolic Diseases Clotrimazole Miconazole Tioconazole Diabetes Mellitus |
Endocrine System Diseases Tacrolimus Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Cyclosporins |
Anti-Infective Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antifungal Agents Physiological Effects of Drugs |
Enzyme Inhibitors Antirheumatic Agents Dermatologic Agents Immunosuppressive Agents Pharmacologic Actions |