Exchange of Azathioprine by Mycophenolatmofetile and Cyclosporine A Dose Reduction After Heart Transplantation
NCT00359814 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23
Last updated 2009-02-16
Summary
The purpose of this study is to improve or save renal function by optimizing the immunosuppressive regimen by reducing the Cyclosporine A dose and the exchange of Azathioprine by Mycophenolatmofetile, which is an effective immunosuppressive agent and will minimize the risk of acute rejection episodes.
Conditions
- Heart Transplantation
Interventions
- DRUG
-
Mycophenolatmofetile
Mycophenolatmofetile administration: was started with 250 mg/daily at day 1, the start dose was increased about 250 mg/daily every week till 2 g/daily
- DRUG
-
Cyclosporin A
Cyclosporin A reduction: Cyclosporin A trough level reduction started after week 8. The new target range was 50 to 90 ng/ml
Sponsors & Collaborators
- collaborator INDUSTRY
-
Hannover Medical School
lead OTHER
Principal Investigators
-
Christoph Bara, Dr. med. · Hannover Medical School, Department of Thoracic and Cardiovascular Surgery
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-11-30
- Primary Completion
- 2008-06-30
- Completion
- 2008-06-30
Countries
- Germany
Study Locations
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