NCT00282217

Brief Summary

The aim of this study is to test whether withdrawal of calcineurin inhibitors, followed by treatment with sirolimus, may improve renal function in renal transplant recipients with chronic allograft nephropathy.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

13 active sites

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

First Submitted

Initial submission to the registry

January 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 25, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
Last Updated

March 22, 2007

Status Verified

March 1, 2007

First QC Date

January 24, 2006

Last Update Submit

March 21, 2007

Conditions

Kidney FailureKidney Diseases

Keywords

Kidney FailureKidney TransplantGraft RejectionKidney Transplantation

Outcome Measures

Primary Outcomes (1)

  • Renal function at 12 months; Comparison between slopes of glomerular filtration rate (GFR) of one year before versus one year after start on sirolimus

Secondary Outcomes (3)

  • Histological parameters at 12 months

  • Cumulative incidence of biopsy-confirmed acute rejection at 12 months

  • Effect at 12 months on proteinuria, blood pressure, hyperlipidemia, and proteinuria

Interventions

SirolimusDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Renal transplantation
  • Biopsy-confirmed chronic rejection
  • Treatment with mofetil mycophenolate among cyclosporine or tacrolimus

You may not qualify if:

  • Transplant of any organ other than the kidney
  • Current important infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

A Coruña, 15006, Spain

Location

Unknown Facility

Albacete, 2006, Spain

Location

Unknown Facility

Barcelona, 8035, Spain

Location

Unknown Facility

Cadiz, 11009, Spain

Location

Unknown Facility

Granada, 18014, Spain

Location

Unknown Facility

L'Hospitalet de Llobregat, 8701, Spain

Location

Unknown Facility

Madrid, 28034, Spain

Location

Unknown Facility

Madrid, 28035, Spain

Location

Unknown Facility

Madrid, 28040, Spain

Location

Unknown Facility

Málaga, 29010, Spain

Location

Unknown Facility

Oviedo, 33006, Spain

Location

Unknown Facility

Seville, 41013, Spain

Location

Unknown Facility

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Renal InsufficiencyKidney Diseases

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

Urologic 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

  • Trial Manager

    For Spain, infomed@wyeth.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 24, 2006

First Posted

January 25, 2006

Study Start

August 1, 2006

Last Updated

March 22, 2007

Record last verified: 2007-03

Locations

ES(13)