NCT00167947

Study Evaluating Sirolimus in Kidney Transplant Recipients.

A Randomized, Open Label Study to Evaluate the Effects of a Regimen With Sirolimus,Low Doses Cyclosporine and Steroids vs a Regimen With Sirolimus and Steroids, After an Induction Period With Basiliximab, Sirolimus,Cyclosporine and Steroids in de Novo Renal Transplant Patients.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Renal function at 12 months assessed by calculated creatinine clearance.

Conditions

• Kidney Failure
• Graft vs Host Disease

Interventions

Type	Name	Description
DRUG	Cyclosporine	Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "
DRUG	Steroids	Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "
DRUG	Rapamune (Sirolimus)	Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "

Timeline

• Start date: 2005-01-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2005-09-14
• Last updated: 2008-03-14

Locations

14 sites across 1 country: Italy