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

Not Applicable

Completed

• Conditions: Heart Transplantation
• Interventions: Drug: Mycophenolatmofetile; Drug: Cyclosporin A

• Registration Number: NCT00359814
• Lead Sponsor: Hannover Medical School

Brief 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.

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 effects.Long-term administration of calcineurin inhibitors is associated with chronic nephrotoxicity.

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2006-08-01
• Study First Submitted QC: 2006-08-01
• Study First Posted: 2006-08-02
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-13
• Last Update Posted: 2009-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Mycophenolatmofetile	Azathioprine administration: was stopped at day 0; Mycophenolatmofetile administration: was started with 250 mg/daily at day 1, the start dose was increased about 250 mg/daily every week till 2 g/daily; Cyclosporin A reduction: Cyclosporin A trough level reduction started after week 8. The new target range was 50 to 90 ng/ml
1	Cyclosporin A	Azathioprine administration: was stopped at day 0; Mycophenolatmofetile administration: was started with 250 mg/daily at day 1, the start dose was increased about 250 mg/daily every week till 2 g/daily; Cyclosporin A reduction: Cyclosporin A trough level reduction started after week 8. The new target range was 50 to 90 ng/ml

Primary Outcome Measures

Name	Time	Method
Renal function evaluated by serum creatinine at month 12 and month 24	month 12 and month 24

Secondary Outcome Measures

Name	Time	Method
acute rejection episodes, gastrointestinal disorders and other adverse events at month 12 and month 24	month 12 and month 24
Cardiovascular risk factors at month 12 and month 24	month 12 and month 24
Quality of life assessed by the SF36, spiroergometry, concomitant medication at month 12 and month 24	month 12 and month 24

Trial Locations

Locations (1)

Hannover Medical School, Department of Thoracic and Cardiovascular Surgery; 🇩🇪 Hannover, Germany