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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00137345

Enrollment

500

Registered

2005-08-29

Start date

2005-06-30

Completion date

2006-08-31

Last updated

2013-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant

Keywords

Randomized controlled trial, Clinical Trial Phase III, Drug therapy, Immunosuppression, Treatment outcome, Kidney transplantation, Kidney function tests

Brief 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.

Interventions

DRUGsirolimus

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

13 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
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)	—
Non-inferiority of the composite of graft loss and death at 52 weeks	—

Secondary

Measure	Time frame
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	—
quality of life at 24, 52 and 104 weeks	—

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026