Study Evaluating Two Different Sirolimus-based Immunosuppressive Regimens in Elderly Kidney Transplant Recipients

January 26, 2012 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

Open, Pilot, Comparative Study to Evaluate the Efficacy and Safety of Two Immunosuppressor Regimens, Anti Il-2, Sirolimus Mycophenolate, Mophetyl and Steroids Versus Sirolimus, Cyclosporine, and Withdrawal of Cyclosporine Since the Third Month and Steroids in Elderly Population

The purpose of this study is to test two different sirolimus-based immunosuppressive regimens for elderly kidney transplant recipients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: Sirolimus

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

End stage renal disease
Kidney transplantation
Both donor and recipient older than 60 years

Exclusion Criteria:

Prior or concurrent transplant of any organ other than the kidney
Current clinically significant infections

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Renal function at 3 and 12 months; measured by Cockroft-Gault formula or serum creatinine

Secondary Outcome Measures

Outcome Measure
Incidence of acute rejections at 3 and 12 months
Patient and graft survival at 3 and 12 months
Incidence and duration of episodes of acute tubular necrosis
Time to recover renal function (creatinine< 2 mg/dl)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

November 11, 2005

First Submitted That Met QC Criteria

November 14, 2005

First Posted (Estimate)

November 16, 2005

Study Record Updates

Last Update Posted (Estimate)

January 31, 2012

Last Update Submitted That Met QC Criteria

January 26, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

0468-100970

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.