Status:
COMPLETED
Rapamycin Use in Calcineurin Inhibitor (CNI)-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation
Lead Sponsor:
Heidelberg University
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Heart Transplantation
Renal Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Clinical Problem: Renal insufficiency after heart transplantation caused by cyclosporine medication was addressed. Current therapeutic approaches include cyclosporine reduction or discontinuation. It ...
Detailed Description
Clinical Problem: Renal insufficiency after heart transplantation caused by cyclosporine medication was addressed. Current therapeutic approaches include cyclosporine reduction or discontinuation. It ...
Eligibility Criteria
Inclusion
- Heart transplantation (\> 6 months post-operation)
- Renal failure (serum creatinine stably \> 1.7 mg/dl
- Cyclosporine trough blood level \< 110 ng/ml
Exclusion
- \< 18 years of age
- Rapamycin intolerability
- Active infection
- Pregnancy, breast feeding
- Major elective surgery planned in study period
- Thrombopenia \< 100,000/ml
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00123331
Start Date
October 1 2003
End Date
April 1 2005
Last Update
August 2 2005
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medizinische Universitätsklinik, Kardiologie
Heidelberg, Germany, D-69115