Study Evaluating Sirolimus in the Treatment of Kidney Transplant

NCT ID: NCT00282217

Last Updated: 2007-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Failure Kidney Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Sirolimus

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Transplant of any organ other than the kidney
* Current important infection
* Acute rejection within 12 weeks prior to inclusion
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Spain, [email protected]

Locations

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A Coruña, , Spain

Site Status

Albacete, , Spain

Site Status

Barcelona, , Spain

Site Status

Cadiz, , Spain

Site Status

Granada, , Spain

Site Status

L'Hospitalet de Llobregat, , Spain

Site Status

Madrid, , Spain

Site Status

Madrid, , Spain

Site Status

Madrid, , Spain

Site Status

Málaga, , Spain

Site Status

Oviedo, , Spain

Site Status

Seville, , Spain

Site Status

Zaragoza, , Spain

Site Status

Countries

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Spain

Other Identifiers

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101467

Identifier Type: -

Identifier Source: org_study_id

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