Status:
COMPLETED
Withdrawal of Steroids, Cyclosporine A Dose Reduction and Switch to Mycophenolatmofetile 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 first to improve or save renal function and second to decrease cardiac risk factors by optimising the immunosuppressive regimen by withdrawing steroids and reducing the Cy...
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 and corticosteroids for at least six 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 :
40 Patients enrolled
Trial Details
Trial ID
NCT00359658
Start Date
November 1 2004
End Date
June 1 2008
Last Update
February 13 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hannover Medical School, Department of Thoracic and Cardiovascular Surgery
Hanover, Germany, 30625