NCT00254709

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2002

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 16, 2005

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

First QC Date

November 11, 2005

Last Update Submit

January 26, 2012

Conditions

Kidney FailureGraft RejectionAged

Keywords

kidney transplantelderly

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

  • 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)

Interventions

SirolimusDRUG

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2005

First Posted

November 16, 2005

Study Start

October 1, 2002

Study Completion

September 1, 2005

Last Updated

January 31, 2012

Record last verified: 2012-01