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

Heart Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00359814
• Other study ID #: KKS-95/2004
• Status: Completed
• Phase: N/A
• First received: August 1, 2006
• Last updated: February 13, 2009
• Start date: November 2004
• Est. completion date: June 2008

Study information

• Verified date: February 2009
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Transplantation

Intervention

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

Locations

Country	Name	City	State
Germany	Hannover Medical School, Department of Thoracic and Cardiovascular Surgery	Hannover

Sponsors (2)

Lead Sponsor	Collaborator
Hannover Medical School	Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal function evaluated by serum creatinine at month 12 and month 24		month 12 and month 24	No
Secondary	acute rejection episodes, gastrointestinal disorders and other adverse events at month 12 and month 24		month 12 and month 24	Yes
Secondary	Cardiovascular risk factors at month 12 and month 24		month 12 and month 24	No
Secondary	Quality of life assessed by the SF36, spiroergometry, concomitant medication at month 12 and month 24		month 12 and month 24	No