Clinical Trials Directory

Trials / Completed

CompletedNCT00248313

Study Comparing Cyclosporin Dose Reduction With Cyclosporin Elimination in Kidney Transplant Recipients Taking Sirolimus

A Randomized, Open-label Study to Compare the Safety and Efficacy of Cyclosporin Dose Reduction With Cyclosporin Elimination in de Novo Renal Allograft Recipients Receiving Rapamune

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
470 (planned)
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

To assess equivalence in the rates of functional graft survival at 12 months after transplantation in patients receiving induction therapy with cyclosporin (CsA, Neoral) and Rapamune® followed by CsA dose reduction and concentration-controlled Rapamune® versus induction with CsA and Rapamune® followed by discontinuation of CsA and concentration-controlled Rapamune®.

Conditions

Interventions

TypeNameDescription
DRUGRapamune®

Timeline

Start date
2000-07-01
Completion
2007-10-01
First posted
2005-11-03
Last updated
2010-03-10

Source: ClinicalTrials.gov record NCT00248313. Inclusion in this directory is not an endorsement.