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

Heart Transplantation Clinical Trial

Official title:

Conversion Study to Optimize Immunosuppressive Regimen by Withdrawal of Steroids, Cyclosporine A Dose Reduction and a Switch to Mycophenolatmofetile for Patients After Heart Transplantation in the Long-Term.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00359658
• Other study ID #: KKS-94/2004
• Status: Completed
• Phase: N/A
• First received: August 1, 2006
• Last updated: February 12, 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 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.

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. Calcineurin inhibitors are associated with chronic nephrotoxicity, while long-term administration of steroids results in an increased incidence of cardiovascular risk factors (e.g. hypertension, lipometabolic disorders, steroid induced diabetes, adipositas)and therefore, carries the potential of graft disfunction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• 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 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

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:
• prednisolon
prednisolon withdrawal: reduction of maintenance dosage, 0,5 mg of the daily dose every week till withdrawal
• Mycophenolatmofetile
Mycophenolatmofetile administration: start doses 250 mg, increase of the daily dose about 250 mg every week till reaching 2 g/daily
• Cyclosporin A
Cyclosporin A reduction: 8 weeks after starting prednisolon withdrawal and Mycophenolatmofetile administration reduction of Cyclosporin A trough level till a range from 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	Cardiovascular risk factors 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	Quality of life assessed by the SF36, spiroergometry, concomitant medication at month 12 and month 24		month 12 and month 24	No