Status:
COMPLETED
Exchange of Azathioprine by Mycophenolatmofetile and Cyclosporine A Dose Reduction After Heart Transplantation
Lead Sponsor:
Hannover Medical School
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Heart Transplantation
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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,...
Detailed Description
The decrease of quality of life in patients after heart transplantation in the long-term is determined by an increasing incidence of transplant vasculopathy and by immunosuppression-related side effec...
Eligibility Criteria
Inclusion
- Current immunosuppressive regimen: Cyclosporine A, Azathioprine and corticosteroids for at least 12 month
- Heart transplantation above 3 years dated back
- Serum creatinine \< 3,5 mg/dl (310 µmol/l) and BUN \< 150 mg/dl
- Cyclosporine A blood level between 50 and 250 ng/ml during the last 12 month
Exclusion
- Carcinoma within the last 3 years
- Acute rejection episodes during the last 6 month
- Infection requiring therapeutic intervention
- Hepatitis B, Hepatitis C or HIV infection
- WBC \< 3000/µl, haemoglobin \< 9g/dl, platelets \< 70.000/µl
- Florid gastrointestinal ulcer
- Haemodialysis within the last 4 weeks before study entry
- Pregnancy / lactation
- Administration of other immunosuppressive agents than prescribed
- Mycophenolatmofetile incompatibility
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00359814
Start Date
November 1 2004
End Date
June 1 2008
Last Update
February 16 2009
Active Locations (1)
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1
Hannover Medical School, Department of Thoracic and Cardiovascular Surgery
Hanover, Germany, 30625