Overview

Exchange of Azathioprine by Mycophenolatmofetile and Cyclosporine A Dose Reduction After Heart Transplantation

Status:
Completed
Trial end date:
2008-06-01
Target enrollment:
0
Participant gender:
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/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hannover Medical School
Collaborator:
Hoffmann-La Roche
Treatments:
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