Freedom Study: Myfortic in Kidney Transplant Patients

Completed · Phase 3

Conditions studied: Kidney Transplantation

In brief

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

Key facts

Study ID

NCT00101738

Run by

Novartis Pharmaceuticals

People needed

342

Starts

2003-03-01

Expected to finish

2005-05-01

Last updated by the study team

2011-01-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• UCSF Kidney Transplant Service — San Francisco, California, United States
• 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
• Legacy Research & Technology Ctr. — Portland, Oregon, United States
• U. of Wisconsin Hospital Clinics — Madison, Wisconsin, United States
• Crai Norte — San Martín, Buenos Aires, Argentina
• Hospital Cordoba — Córdoba, Córdoba Province, Argentina
• Unidad de Transplante Velez Sarsfield — Córdoba, Córdoba Province, Argentina
• Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
• The Queen Elizabeth Hospital — Woodville, South Australia, Australia
• Monash Medical Centre — Clayton, Victoria, Australia
• Royal Melbourne Hospital — Parkville, Victoria, Australia
• Hospital das Clinicas - UNICAMP — Campinas, São Paulo, Brazil
• Hipertensao Hospital do Rim e Hipertensao — São Paulo, São Paulo, Brazil
• Foothills Medical Center — Calgary, Alberta, Canada
• University of Alberta Hospital — Edmonton, Alberta, Canada
• Queen II Health and Science Center — Halifax, Nova Scotia, Canada
• St. Michael's Hospital — Toronto, Ontario, Canada
• University Health Network, The Toronto Hospital — Toronto, Ontario, Canada
• McGill University Health Centre — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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