Withdrawal of Steroids, Cyclosporine A Dose Reduction and Switch to Mycophenolatmofetile After Heart Transplantation

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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 Cyclosporine A dose. The concomitant administration of Mycophenolatmofetile, an effective immunosuppressive agent, 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: Cyclosporine; Cyclosporins; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• 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 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