Freedom Study: Myfortic in Kidney Transplant Patients
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
1 other identifier
interventional
342
13 countries
44
Brief Summary
The primary objective of the study is to evaluate that 3 immunosuppressant regimens will have comparable kidney function results in kidney transplant patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2003
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
January 12, 2005
CompletedFirst Posted
Study publicly available on registry
January 13, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedJanuary 31, 2011
January 1, 2011
2.2 years
January 12, 2005
January 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Calculated glomerular filtration rate after 12 months treatment
Secondary Outcomes (5)
Incidence of death, graft loss, biopsy-proven acute rejection after 3 and 12 months.
Patient and graft survival after 12 months.
Incidence of AEs and SAEs after 3 and 12 months.
Blood pressure, lipids and glucose profiles after 3 and 12 months.
Percentage of patients free of steroids at 12 months
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
UCSF Kidney Transplant Service
San Francisco, California, 94143-0780, United States
Livelink, Inc.
Tampa, Florida, 33606, United States
Loyola Medical Center
Maywood, Illinois, 60153, United States
Indiana U. Medical Center
Indianapolis, Indiana, 46202, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
University Hospitals of Cleveland, Division of Nephrology
Cleveland, Ohio, 44106, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Legacy Research & Technology Ctr.
Portland, Oregon, 97232, United States
U. of Wisconsin Hospital Clinics
Madison, Wisconsin, 53792-7375, United States
Crai Norte
San Martín, Buenos Aires, 1650, Argentina
Hospital Cordoba
Córdoba, Córdoba Province, 5000, Argentina
Unidad de Transplante Velez Sarsfield
Córdoba, Córdoba Province, X5016JDA, Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
The Queen Elizabeth Hospital
Woodville, South Australia, 5011, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3052, Australia
Hospital das Clinicas - UNICAMP
Campinas, São Paulo, 13083-970, Brazil
Hipertensao Hospital do Rim e Hipertensao
São Paulo, São Paulo, 04023 900, Brazil
Foothills Medical Center
Calgary, Alberta, T2N 2T9, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
Queen II Health and Science Center
Halifax, Nova Scotia, B3H 2Y6, Canada
St. Michael's Hospital
Toronto, Ontario, M5C 2T2, Canada
University Health Network, The Toronto Hospital
Toronto, Ontario, M5G 2C4, Canada
McGill University Health Centre
Montreal, Quebec, H3A 1A1, Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
Staedt. Krankenhaus Koeln-Merheim
Cologne, 51109, Germany
Klinikum der Johann Wolfgang Geothe-Universitaet
Frankfurt am Main, 60596, Germany
Ospedale Consorziale e policlinico-Universita degli Studi
Bari, BA, 70124, Italy
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
Auckland Hospital
Auckland, Grafton, New Zealand
Singapore General Hospital
Singapore, 169608, Singapore
Hospital Clinico San Carlos
Madrid, Madrid, 28040, Spain
Hospital Central de Asturias
Oviedo, Oviedo, 33006, Spain
Hospital de Bellvitge
L'Hospitalet de Llobregat, 08907, Spain
Chang-Gung Memorial Hospital-Linko
Taoyuan District, Lin-Ko, 333, Taiwan
Taipei Veterans General Hospital
Taipei, ROC, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Queen Elizabeth Medical Centre
Edgbaston, Birmingham, B15 2TH, United Kingdom
University Hospital of Wales
Heathpark, Cardiff, CF14 4XW, United Kingdom
Walsgrave Hospital NHS Trust
Walsgrave on Sowe, Coventry, CV2 2DX, United Kingdom
Freeman Hospital
High Heaton, Newcastle Upon Tyne, NE7 7DN, United Kingdom
Guy's Hospital
London, SE1 9RT, United Kingdom
Nottingham City Hospital
Nottingham, NG5 1BP, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis
Novartis
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 12, 2005
First Posted
January 13, 2005
Study Start
March 1, 2003
Primary Completion
May 1, 2005
Study Completion
May 1, 2005
Last Updated
January 31, 2011
Record last verified: 2011-01