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

Wyeth

Status and phase: Terminated; Phase 3

Conditions: Kidney Transplant

Treatments: Drug: sirolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00137345

B1741188 (Other Identifier)

0468H1-318

Details and patient eligibility

About

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.

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)