Freedom Study: Myfortic in Kidney Transplant Patients
- Conditions
- Kidney Transplantation
- Registration Number
- NCT00101738
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 342
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Calculated glomerular filtration rate after 12 months treatment
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (44)
Queen Elizabeth Medical Centre
🇬🇧Edgbaston, Birmingham, United Kingdom
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Walsgrave Hospital NHS Trust
🇬🇧Walsgrave, Coventry, United Kingdom
Hipertensao Hospital do Rim e Hipertensao
🇧🇷Sao Paulo, SP, Brazil
U. of Wisconsin Hospital Clinics
🇺🇸Madison, Wisconsin, United States
Unidad de Transplante Velez Sarsfield
🇦🇷Cordoba, Argentina
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Hospital Kuala Lumpur
🇲🇾Kuala Lumpur, Malaysia
Chang-Gung Memorial Hospital-Linko
🇨🇳Tao-Yuan, Lin-Ko, Taiwan
McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
Auckland Hospital
🇳🇿Auckland, Grafton, New Zealand
Klinikum der Johann Wolfgang Geothe-Universitaet
🇩🇪Frankfurt am Main, Germany
Royal University Hospital
🇨🇦Saskatoon, Saskatchewan, Canada
Staedt. Krankenhaus Koeln-Merheim
🇩🇪Koeln, Germany
Taipei Veterans General Hospital
🇨🇳Taipei, ROC, Taiwan
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Ospedale Consorziale e policlinico-Universita degli Studi
🇮🇹Bari, BA, Italy
University Hospital of Wales
🇬🇧Heath Park, Cardiff, United Kingdom
Hospital Central de Asturias
🇪🇸Oviedo, Spain
Nottingham City Hospital
🇬🇧Nottingham, United Kingdom
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Hospital de Bellvitge
🇪🇸L'hospitalet de Llobregat, Spain
Foothills Medical Center
🇨🇦Calgary, Alberta, Canada
The Queen Elizabeth Hospital
🇦🇺Woodville, South Australia, Australia
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Crai Norte
🇦🇷San Martin, Buenos Aires, Argentina
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Hospital Cordoba
🇦🇷Cordoba, Argentina
Hospital das Clinicas - UNICAMP
🇧🇷Campinas, SP, Brazil
Queen II Health and Science Center
🇨🇦Halifax, Nova Scotia, Canada
Singapore General Hospital
🇸🇬Singapore, Singapore
Freeman Hospital
🇬🇧High Heaton, Newcastle Upon Tyne, United Kingdom
UCSF Kidney Transplant Service
🇺🇸San Francisco, California, United States
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Livelink, Inc.
🇺🇸Tampa, Florida, United States
Loyola Medical Center
🇺🇸Maywood, Illinois, United States
Indiana U. Medical Center
🇺🇸Indianapolis, Indiana, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
University Hospitals of Cleveland, Division of Nephrology
🇺🇸Cleveland, Ohio, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Legacy Research & Technology Ctr.
🇺🇸Portland, Oregon, United States
University Health Network, The Toronto Hospital
🇨🇦Toronto, Ontario, Canada
Guy's Hospital
🇬🇧London, United Kingdom