Freedom Study: Myfortic in Kidney Transplant Patients

January 28, 2011 updated by: Novartis Pharmaceuticals

Study to Investigate the Clinical Outcomes of Different Regimens of Myfortic® in De Novo Kidney Tx Pts Using Simulect® and Neoral® With or Without Steroids

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

342

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina, 5000
        • Hospital Cordoba
      • Cordoba, Argentina, X5016JDA
        • Unidad de Transplante Velez Sarsfield
    • Buenos Aires
      • San Martin, Buenos Aires, Argentina, 1650
        • Crai Norte
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Woodville, South Australia, Australia, 5011
        • The Queen Elizabeth Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • Parkville, Victoria, Australia, 3052
        • Royal Melbourne Hospital
  • Brazil
    • SP
      • Campinas, SP, Brazil, 13083-970
        • Hospital das Clinicas - UNICAMP
      • Sao Paulo, SP, Brazil, 04023 900
        • Hipertensao Hospital do Rim e Hipertensao
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Center
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y6
        • Queen II Health and Science Center
    • Ontario
      • Toronto, Ontario, Canada, M5C 2T2
        • St. Michael's Hospital
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network, The Toronto Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • McGill University Health Centre
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Royal University Hospital
  • Germany
      • Frankfurt am Main, Germany, 60596
        • Klinikum der Johann Wolfgang Geothe-Universitaet
      • Koeln, Germany, 51109
        • Staedt. Krankenhaus Koeln-Merheim
  • Italy
    • BA
      • Bari, BA, Italy, 70124
        • Ospedale Consorziale e policlinico-Universita degli Studi
  • Malaysia
      • Kuala Lumpur, Malaysia, 50586
        • Hospital Kuala Lumpur
  • New Zealand
    • Grafton
      • Auckland, Grafton, New Zealand
        • Auckland Hospital
  • Singapore
      • Singapore, Singapore, 169608
        • Singapore General Hospital
  • Spain
      • L'hospitalet de Llobregat, Spain, 08907
        • Hospital De Bellvitge
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Oviedo, Spain, 33006
        • Hospital Central de Asturias
  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
    • Lin-Ko
      • Tao-Yuan, Lin-Ko, Taiwan, 333
        • Chang-Gung Memorial Hospital-Linko
    • ROC
      • Taipei, ROC, Taiwan
        • Taipei Veterans General Hospital
  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Guy's Hospital
      • Nottingham, United Kingdom, NG5 1BP
        • Nottingham City Hospital
    • Birmingham
      • Edgbaston, Birmingham, United Kingdom, B15 2TH
        • Queen Elizabeth Medical Centre
    • Cardiff
      • Heath Park, Cardiff, United Kingdom, CF14 4XW
        • University Hospital of Wales
    • Coventry
      • Walsgrave, Coventry, United Kingdom, CV2 2DX
        • Walsgrave Hospital NHS Trust
    • Newcastle Upon Tyne
      • High Heaton, Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • Freeman Hospital
  • United States
    • California
      • San Francisco, California, United States, 94143-0780
        • UCSF Kidney Transplant Service
    • Florida
      • Tampa, Florida, United States, 33606
        • Livelink, Inc.
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana U. Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland, Division of Nephrology
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center
    • Oregon
      • Portland, Oregon, United States, 97232
        • Legacy Research & Technology Ctr.
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-7375
        • U. of Wisconsin Hospital Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Calculated glomerular filtration rate after 12 months treatment

Secondary Outcome Measures

Outcome Measure
Incidence of AEs and SAEs after 3 and 12 months.
Blood pressure, lipids and glucose profiles after 3 and 12 months.
Incidence of death, graft loss, biopsy-proven acute rejection after 3 and 12 months.
Patient and graft survival after 12 months.
Percentage of patients free of steroids at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

May 1, 2005

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

January 12, 2005

First Submitted That Met QC Criteria

January 12, 2005

First Posted (Estimate)

January 13, 2005

Study Record Updates

Last Update Posted (Estimate)

January 31, 2011

Last Update Submitted That Met QC Criteria

January 28, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CERL080A2404

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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