Clinical trial NCT00101738: Freedom Study: Myfortic in Kidney Transplant Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Transplantation
Keywords: MPA
Kidney Transplantation
Acute rejection
Kidney function
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-01-13
Enrollment: 342
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Calculated glomerular filtration rate after 12 months treatment
Secondary outcomes:
measure: Incidence of death, graft loss, biopsy-proven acute rejection after 3 and 12 months.
measure: Patient and graft survival after 12 months.
measure: Incidence of AEs and SAEs after 3 and 12 months.
measure: Blood pressure, lipids and glucose profiles after 3 and 12 months.
measure: Percentage of patients free of steroids at 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Kidney Transplant Service
state: California
city: Tampa
country: United States
facility: Livelink, Inc.
state: Florida
city: Maywood
country: United States
facility: Loyola Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana U. Medical Center
state: Indiana
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Cleveland
country: United States
facility: University Hospitals of Cleveland, Division of Nephrology
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Portland
country: United States
facility: Legacy Research & Technology Ctr.
state: Oregon
city: Madison
country: United States
facility: U. of Wisconsin Hospital Clinics
state: Wisconsin
city: San Martin
country: Argentina
facility: Crai Norte
state: Buenos Aires
city: Cordoba
country: Argentina
facility: Hospital Cordoba
city: Cordoba
country: Argentina
facility: Unidad de Transplante Velez Sarsfield
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Woodville
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Campinas
country: Brazil
facility: Hospital das Clinicas - UNICAMP
state: SP
city: Sao Paulo
country: Brazil
facility: Hipertensao Hospital do Rim e Hipertensao
state: SP
city: Calgary
country: Canada
facility: Foothills Medical Center
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Halifax
country: Canada
facility: Queen II Health and Science Center
state: Nova Scotia
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network, The Toronto Hospital
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Frankfurt am Main
country: Germany
facility: Klinikum der Johann Wolfgang Geothe-Universitaet
city: Koeln
country: Germany
facility: Staedt. Krankenhaus Koeln-Merheim
city: Bari
country: Italy
facility: Ospedale Consorziale e policlinico-Universita degli Studi
state: BA
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Auckland
country: New Zealand
facility: Auckland Hospital
state: Grafton
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: L'hospitalet de Llobregat
country: Spain
facility: Hospital de Bellvitge
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
city: Tao-Yuan
country: Taiwan
facility: Chang-Gung Memorial Hospital-Linko
state: Lin-Ko
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
state: ROC
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Edgbaston
country: United Kingdom
facility: Queen Elizabeth Medical Centre
state: Birmingham
city: Heath Park
country: United Kingdom
facility: University Hospital of Wales
state: Cardiff
city: Walsgrave
country: United Kingdom
facility: Walsgrave Hospital NHS Trust
state: Coventry
city: High Heaton
country: United Kingdom
facility: Freeman Hospital
state: Newcastle Upon Tyne
city: London
country: United Kingdom
facility: Guy's Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References: