Study Comparing Conversion From Calcineurin Inhibitors to Rapamune Versus Standard Therapy in Established Renal Allograft Recipients

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00273871
First received: January 5, 2006
Last updated: March 7, 2011
Last verified: May 2007

January 5, 2006
March 7, 2011
January 2002
Not Provided
Difference between treatment groups in renal function at 12 months.
Same as current
Complete list of historical versions of study NCT00273871 on ClinicalTrials.gov Archive Site
Incidence of acute rejection, patient and graft survival at 12 months, labs and physical examinations, quality of life etc.
Same as current
Not Provided
Not Provided
 
Study Comparing Conversion From Calcineurin Inhibitors to Rapamune Versus Standard Therapy in Established Renal Allograft Recipients
A Multi-centre, Randomized, Open-label, Study to Compare Conversion From Calcineurin Inhibitors to Rapamune Versus Standard Therapy in Established Renal Allograft Recipients on Maintenance Therapy With Mild to Moderate Renal Insufficiency.

The purpose of the study is to determine the effect of conversion from calcineurin inhibitor based therapy to Rapamune based therapy in patients with mild to moderate renal insufficiency.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Graft Rejection
  • Kidney Failure
  • Kidney Transplantation
Drug: Cyclosporin or tacrolimus
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
190
September 2006
Not Provided

Inclusion Criteria:

  • Age over 18
  • Treatment with a calcineurin inhibitor
  • Patients with mild to moderate renal insufficiency

Exclusion Criteria:

  • Patients with acute rejection
  • Patients who received a transplant more than 10 years ago
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00273871
0468H1-100535
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For United Kingdom and Ireland, ukmedinfo@wyeth.com
Wyeth is now a wholly owned subsidiary of Pfizer
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP