Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients - Tabular View

Tracking Information

First Received Date ^ICMJE

June 5, 2002

Last Updated Date

January 17, 2008

Start Date ^ICMJE

January 2002

Estimated Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Efficacy: To determine the effect of conversion from CI- to SRL-based therapy on renal function 52 weeks after randomization. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00038948 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

equivalence 52 weeks after randomization between treatment groups in the composite endpoint of the incidence of the first occurrence of biopsy-confirmed acute rejection, graft loss, or death. [ Time Frame: 104, 156, 208 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients

Official Title ^ICMJE

A Randomized, Open-Label, Comparative Evaluation of Conversion From Calcineurin Inhibitors to Sirolimus Versus Continued Use of Calcineurin Inhibitors in Renal Allograft Recipients

Brief Summary

The purpose of this study is to determine the effect of conversion from calcineurin inhibitor to sirolimus based therapy on renal function.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Renal Allograft Recipients

Intervention ^ICMJE

Drug: Sirolimus

Study Arms / Comparison Groups

Active Comparator: Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression
Active Comparator: Continued calcineurin inhibitor therapy

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

830

Estimated Completion Date

April 2008

Estimated Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age greater than or equal to 13 years.
Receiving CsA or tacrolimus from the time of transplantation or within 2 weeks thereafter
Patients with a functioning allograft and a Nankivell GFR greater than or equal to 20 mL/min, within 2 weeks before randomization

Exclusion Criteria:

Biopsy-confirmed acute rejection within 12 weeks before randomization, that was determined to require antirejection treatment
Patients in whom kidney-pancreas or other multiple organ transplants have been performed

Gender

Both

Ages

13 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00038948

Responsible Party

Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth

Study ID Numbers ^ICMJE

0468H1-316

Study Sponsor ^ICMJE

Wyeth

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor, MD

Wyeth

Information Provided By

Wyeth

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP