Rapamycin Use in Calcineurin Inhibitor (CNI)-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Rapamycin Use in CNI-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation |
- Renal function after 6 months (serum creatinine, calculated creatinine clearance)
- Survival
- Rejection (clinical)
- Tolerability
- Blood pressure
| 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:
- Heart transplantation (> 6 months post-operation)
- Renal failure (serum creatinine stably > 1.7 mg/dl
- Cyclosporine trough blood level < 110 ng/ml
Exclusion Criteria:
- < 18 years of age
- Rapamycin intolerability
- Active infection
- Pregnancy, breast feeding
- Major elective surgery planned in study period
- Thrombopenia < 100,000/ml
Contacts and Locations| Germany | |
| Medizinische Universitätsklinik, Kardiologie | |
| Heidelberg, Germany, D-69115 | |
| Principal Investigator: | Thomas J Dengler, MD | University of Heidelberg |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00123331 History of Changes |
| Other Study ID Numbers: | HD_cardio_352/2003_dengler |
| Study First Received: | July 18, 2005 |
| Last Updated: | August 1, 2005 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University of Heidelberg:
|
Heart transplantation Renal failure Cyclosporine Rapamycin |
Additional relevant MeSH terms:
|
Renal Insufficiency Kidney Diseases Urologic Diseases Cyclosporins Cyclosporine Sirolimus Everolimus Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents Antibiotics, Antineoplastic Antineoplastic Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 19, 2013