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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
342

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Calculated glomerular filtration rate after 12 months treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2005

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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