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

ClinicalTrials.gov ID: NCT00137345

Public ClinicalTrials.gov record NCT00137345. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 21, 2026, 3:08 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT00137345
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 3
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer; Industry
Enrollment: 500 participants

Conditions and interventions

Conditions

Kidney Transplant

Interventions

sirolimus Drug

Drug

Eligibility (public fields only)

Age range: 13 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 31, 2005
Primary completion: Jul 31, 2006
Completion: Jul 31, 2006
Last update posted: Feb 7, 2013

2005 – 2006

United States locations

U.S. sites: 23
U.S. states: 16
U.S. cities: 21

Facility	City	State	ZIP	Site status
Not listed	San Diego	California	92123	—
Not listed	San Francisco	California	94143	—
Not listed	Denver	Colorado	80262	—
Not listed	New Haven	Connecticut	06520	—
Not listed	Gainesville	Florida	32610	—
Not listed	Tampa	Florida	33606	—
Not listed	Atlanta	Georgia	30309	—
Not listed	Chicago	Illinois	60612-3824	—
Not listed	Portland	Maine	04102	—
Not listed	Springfield	Massachusetts	01199	—
Not listed	Detroit	Michigan	48202	—
Not listed	New York	New York	10029	—
Not listed	Charlotte	North Carolina	28203	—
Not listed	Durham	North Carolina	27710	—
Not listed	Cleveland	Ohio	44106	—
Not listed	Cleveland	Ohio	44195	—
Not listed	Toledo	Ohio	43614	—
Not listed	Philadelphia	Pennsylvania	19107	—
Not listed	Philadelphia	Pennsylvania	19129	—
Not listed	Providence	Rhode Island	—	—
Not listed	Charleston	South Carolina	29425	—
Not listed	Dallas	Texas	75246	—
Not listed	Houston	Texas	77225	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 59 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00137345, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Feb 7, 2013 · Synced Sep 21, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00137345 live on ClinicalTrials.gov.

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