NCT00273871

Brief Summary

The purpose of the study is to determine the effect of conversion from calcineurin inhibitor based therapy to Rapamune based therapy in patients with mild to moderate renal insufficiency.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
190

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2002

Longer than P75 for phase_3

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

January 1, 2002

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

March 8, 2011

Status Verified

May 1, 2007

First QC Date

January 5, 2006

Last Update Submit

March 7, 2011

Conditions

Graft RejectionKidney FailureKidney Transplantation

Keywords

kidney transplant

Outcome Measures

Primary Outcomes (1)

  • Difference between treatment groups in renal function at 12 months.

Secondary Outcomes (1)

  • Incidence of acute rejection, patient and graft survival at 12 months, labs and physical examinations, quality of life etc.

Interventions

Cyclosporin or tacrolimusDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18
  • Treatment with a calcineurin inhibitor
  • Patients with mild to moderate renal insufficiency

You may not qualify if:

  • Patients with acute rejection
  • Patients who received a transplant more than 10 years ago

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Renal Insufficiency

Interventions

CyclosporineTacrolimus

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsMacrolidesLactonesOrganic Chemicals

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

  • Trial Manager

    For United Kingdom and Ireland, ukmedinfo@wyeth.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 5, 2006

First Posted

January 9, 2006

Study Start

January 1, 2002

Study Completion

September 1, 2006

Last Updated

March 8, 2011

Record last verified: 2007-05