Overview
Exchange of Azathioprine by Mycophenolatmofetile and Cyclosporine A Dose Reduction After Heart Transplantation
Status:
Completed
Completed
Trial end date:
2008-06-01
2008-06-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Hannover Medical SchoolCollaborator:
Hoffmann-La RocheTreatments:
Azathioprine
Cyclosporine
Cyclosporins
Criteria
Inclusion Criteria:- 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 Criteria:
- 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