Study Comparing Sirolimus With Cyclosporine in a Calcineurin Inhibitor (CNI)-Free Regimen in Kidney Transplant Recipients

Kidney Transplant Clinical Trial

Official title:

A Randomized, Open-Label, Comparative Evaluation of the Safety and Efficacy of Sirolimus Versus Cyclosporine When Combined in a Regimen Containing Basiliximab, Mycophenolate Mofetil, and Corticosteroids in Primary De Novo Renal Allograft Recipients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00137345
• Other study ID #: 0468H1-318
• Secondary ID: B1741188
• Status: Terminated
• Phase: Phase 3
• First received: August 25, 2005
• Last updated: February 7, 2013
• Start date: June 2005
• Est. completion date: August 2006

Study information

• Verified date: September 2006
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if one drug is superior to another with regard to safety and the preservation of renal function after a kidney transplant.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 500
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

Inclusion Criteria:

• Dialysis patients who will be receiving their first kidney transplant

• Weight over 88 pounds (lbs.)

Exclusion Criteria:

• Very high cholesterol levels

• Obesity

• Organ donor over 65 years of age if living; over 60 years of age if cadaveric.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplant

Intervention

Drug:
• sirolimus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Canada,  Chile,  Cyprus,  France,  Germany,  Greece,  Hungary,  Italy,  Norway,  Portugal,  Singapore,  South Africa,  Spain,  Sweden,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To demonstrate the superiority of the sirolimus regimen versus cyclosporin A by intent to treat analysis of kidney function at 52 weeks, measured by mean glomerular filtration rate (GFR)
Primary	Non-inferiority of the composite of graft loss and death at 52 weeks
Secondary	Incidence and severity of rejection at 12, 24, 52, 104, 156, 208 weeks; GFR at 24, 104, 156, 208 weeks; progression of chronic allograft nephropathy or deterioration of transplanted kidney at 52 weeks
Secondary	quality of life at 24, 52 and 104 weeks