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

NCT ID: NCT00359814

Last Updated: 2009-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2008-06-30

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.

Conditions

Heart Transplantation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

Mycophenolatmofetile

Intervention Type: DRUG

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

Intervention Type: DRUG

Cyclosporin A reduction: Cyclosporin A trough level reduction started after week 8. The new target range was 50 to 90 ng/ml

Interventions

Mycophenolatmofetile

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

Intervention Type: DRUG

Cyclosporin A

Cyclosporin A reduction: Cyclosporin A trough level reduction started after week 8. The new target range was 50 to 90 ng/ml

Intervention Type: DRUG

Other Intervention Names

MMF; CellCept; Sandimmun optoral

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

Hannover Medical School

OTHER

Sponsor Role: lead

Responsible Party

Clinic for Cardiothoracic, Transplantation and Vascular Surgery, HannoverMS

Principal Investigators

Christoph Bara, Dr. med.

Role: STUDY_DIRECTOR

Hannover Medical School, Department of Thoracic and Cardiovascular Surgery

Locations

Hannover Medical School, Department of Thoracic and Cardiovascular Surgery

Hanover, , Germany

Countries

Germany

Other Identifiers

KKS-95/2004

Identifier Type: -

Identifier Source: org_study_id