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