NCT00359814

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Hannover Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2004-11-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2006-08-02
• Last updated: 2009-02-16

Locations

1 site across 1 country: Germany