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| Sponsors and Collaborators: |
University of Heidelberg Wyeth |
|---|---|
| Information provided by: | University of Heidelberg |
| ClinicalTrials.gov Identifier: | NCT00123331 |
Purpose
Clinical Problem: Renal insufficiency after heart transplantation caused by cyclosporine medication was addressed. Current therapeutic approaches include cyclosporine reduction or discontinuation. It is unclear whether discontinuation of low dose cyclosporine also has a beneficial effect, i.e. is there a threshold effect for cyclosporine nephrotoxicity?
Study Design: Heart transplant patients with a moderate degree of renal failure on low dose cyclosporine were randomized to either a) no change; or b) discontinuation of cyclosporine and initiation of rapamycin immunosuppression.
Read-Out: Renal function after 6 months; tolerability; and safety were assessed.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Transplantation Renal Failure |
Drug: Cyclosporine discontinuation Drug: Rapamycin medication |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Rapamycin Use in CNI-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation |
| Estimated Enrollment: | 40 |
| Study Start Date: | October 2003 |
| Estimated Study Completion Date: | April 2005 |
Clinical Problem: Renal insufficiency after heart transplantation caused by cyclosporine medication was addressed. Current therapeutic approaches include cyclosporine reduction or discontinuation. It is unclear whether discontinuation of low dose cyclosporine also has a beneficial effect, i.e. is there a threshold effect for cyclosporine nephrotoxicity?
Study Design: Heart transplant patients with a moderate degree of renal failure on low dose cyclosporine were randomized to either a) no change; or b) discontinuation of cyclosporine and initiation of rapamycin immunosuppression.
Read-Out: Renal function after 6 months; tolerability; and safety were assessed.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany | |
| Medizinische Universitätsklinik, Kardiologie | |
| Heidelberg, Germany, D-69115 | |
| Principal Investigator: | Thomas J Dengler, MD | University of Heidelberg |
More Information
| Study ID Numbers: | HD_cardio_352/2003_dengler |
| Study First Received: | July 18, 2005 |
| Last Updated: | August 1, 2005 |
| ClinicalTrials.gov Identifier: | NCT00123331 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Heart transplantation Renal failure Cyclosporine Rapamycin |
|
Sirolimus Renal Insufficiency Cyclosporine Urologic Diseases Clotrimazole |
Miconazole Tioconazole Kidney Diseases Cyclosporins Kidney Failure |
|
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Antibiotics, Antineoplastic |
Immunosuppressive Agents Pharmacologic Actions Anti-Bacterial Agents Antifungal Agents Therapeutic Uses Antirheumatic Agents Dermatologic Agents |
