Freedom Study: Myfortic in Kidney Transplant Patients

NCT ID: NCT00101738

Last Updated: 2011-01-31

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

PHASE3

Total Enrollment

342 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2005-05-31

Brief Summary

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The primary objective of the study is to evaluate that 3 immunosuppressant regimens will have comparable kidney function results in kidney transplant patients.

Detailed Description

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Conditions

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Kidney Transplantation

Keywords

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MPA Kidney Transplantation Acute rejection Kidney function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Myfortic

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males and females aged 18 to 75 years.
* Recipients of first, heart-beating cadaveric, living unrelated or living related non-HLA identical donor kidney transplant, treated with Simulect® and Neoral® as primary immunosuppression.

Exclusion Criteria

* Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any other organ.
* Kidneys from non-heart beating donors or HLA identical living related donors.
* ABO incompatibility against the donor.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis

Principal Investigators

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Novartis

Role: STUDY_DIRECTOR

Novartis

Locations

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UCSF Kidney Transplant Service

San Francisco, California, United States

Site Status

Livelink, Inc.

Tampa, Florida, United States

Site Status

Loyola Medical Center

Maywood, Illinois, United States

Site Status

Indiana U. Medical Center

Indianapolis, Indiana, United States

Site Status

University of Michigan Health System

Ann Arbor, Michigan, United States

Site Status

University Hospitals of Cleveland, Division of Nephrology

Cleveland, Ohio, United States

Site Status

Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

Legacy Research & Technology Ctr.

Portland, Oregon, United States

Site Status

U. of Wisconsin Hospital Clinics

Madison, Wisconsin, United States

Site Status

Crai Norte

San Martín, Buenos Aires, Argentina

Site Status

Hospital Cordoba

Córdoba, Córdoba Province, Argentina

Site Status

Unidad de Transplante Velez Sarsfield

Córdoba, Córdoba Province, Argentina

Site Status

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Site Status

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Site Status

The Queen Elizabeth Hospital

Woodville, South Australia, Australia

Site Status

Monash Medical Centre

Clayton, Victoria, Australia

Site Status

Royal Melbourne Hospital

Parkville, Victoria, Australia

Site Status

Hospital das Clinicas - UNICAMP

Campinas, São Paulo, Brazil

Site Status

Hipertensao Hospital do Rim e Hipertensao

São Paulo, São Paulo, Brazil

Site Status

Foothills Medical Center

Calgary, Alberta, Canada

Site Status

University of Alberta Hospital

Edmonton, Alberta, Canada

Site Status

Queen II Health and Science Center

Halifax, Nova Scotia, Canada

Site Status

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

University Health Network, The Toronto Hospital

Toronto, Ontario, Canada

Site Status

McGill University Health Centre

Montreal, Quebec, Canada

Site Status

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Site Status

Staedt. Krankenhaus Koeln-Merheim

Cologne, , Germany

Site Status

Klinikum der Johann Wolfgang Geothe-Universitaet

Frankfurt am Main, , Germany

Site Status

Ospedale Consorziale e policlinico-Universita degli Studi

Bari, BA, Italy

Site Status

Hospital Kuala Lumpur

Kuala Lumpur, , Malaysia

Site Status

Auckland Hospital

Auckland, Grafton, New Zealand

Site Status

Singapore General Hospital

Singapore, , Singapore

Site Status

Hospital Clinico San Carlos

Madrid, Madrid, Spain

Site Status

Hospital Central de Asturias

Oviedo, Oviedo, Spain

Site Status

Hospital de Bellvitge

L'Hospitalet de Llobregat, , Spain

Site Status

Chang-Gung Memorial Hospital-Linko

Taoyuan District, Lin-Ko, Taiwan

Site Status

Taipei Veterans General Hospital

Taipei, ROC, Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Queen Elizabeth Medical Centre

Edgbaston, Birmingham, United Kingdom

Site Status

University Hospital of Wales

Heathpark, Cardiff, United Kingdom

Site Status

Walsgrave Hospital NHS Trust

Walsgrave on Sowe, Coventry, United Kingdom

Site Status

Freeman Hospital

High Heaton, Newcastle Upon Tyne, United Kingdom

Site Status

Guy's Hospital

London, , United Kingdom

Site Status

Nottingham City Hospital

Nottingham, , United Kingdom

Site Status

Countries

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United States Argentina Australia Brazil Canada Germany Italy Malaysia New Zealand Singapore Spain Taiwan United Kingdom

Other Identifiers

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CERL080A2404

Identifier Type: -

Identifier Source: org_study_id