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

Conversion Study to Optimize Immunosuppressive Regimen by Exchange of Azathioprine by Mycophenolatmofetile and Cyclosporine A Dose Reduction for Patients After Heart Transplantation in Lon-Term

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.

Study Overview

• Status: Completed
• Conditions: Heart Transplantation
• Intervention / Treatment: Drug: Mycophenolatmofetile; Drug: Cyclosporin A

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hannover, Germany, 30625
    • Hannover Medical School, Department of Thoracic and Cardiovascular Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: 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; Other Names: CellCept; MMF; 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; Other Names: Sandimmun optoral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Renal function evaluated by serum creatinine at month 12 and month 24	month 12 and month 24

Secondary Outcome Measures

Outcome Measure	Time Frame
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
acute rejection episodes, gastrointestinal disorders and other adverse events at month 12 and month 24	month 12 and month 24

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Collaborators: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: November 1, 2004
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: August 1, 2006
• First Submitted That Met QC Criteria: August 1, 2006
• First Posted (Estimate): August 2, 2006

Study Record Updates

• Last Update Posted (Estimate): February 16, 2009
• Last Update Submitted That Met QC Criteria: February 13, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: Cyclosporine; renal insufficiency, chronic; long-term care
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Antifungal Agents; Calcineurin Inhibitors; Cyclosporine; Cyclosporins
• Other Study ID Numbers: KKS-95/2004