Status:

TERMINATED

Study Evaluating of Calcineurin Inhibitors Versus Sirolimus in Renal Allograft Recipient

Lead Sponsor:

Wyeth is now a wholly owned subsidiary of Pfizer

Conditions:

Kidney Transplantation

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

This study will evaluate whether conversion from cyclosporine, a calcineurin inhibitor (CI) to sirolimus (SRL) results in improved long-term renal function without a negative impact on safety or immun...

Detailed Description

This open-label, randomized, parallel-group, comparative, outpatient study will be conducted in multiple centers in Taiwan. The study will randomize approximately 120 patients. 80 patients will be ra...

Eligibility Criteria

Inclusion

  • Subjects must be at least 18 years of age.
  • Subjects who are 6 to 60 months after renal transplantation.
  • Subjects who have a stable graft function.

Exclusion

  • Subjects with active major infection, including HIV, decreased platelets, elevated lipids, or multiple organ transplants.

Key Trial Info

Start Date :

April 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2008

Estimated Enrollment :

31 Patients enrolled

Trial Details

Trial ID

NCT00452361

Start Date

April 1 2007

End Date

August 1 2008

Last Update

September 3 2012

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