Freedom Study: Myfortic in Kidney Transplant Patients

Kidney Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00101738
• Other study ID #: CERL080A2404
• Status: Completed
• Phase: Phase 3
• First received: January 12, 2005
• Last updated: January 28, 2011
• Start date: March 2003
• Est. completion date: May 2005

Study information

• Verified date: January 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 342
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Myfortic

Locations

Country	Name	City	State
Argentina	Hospital Cordoba	Cordoba
Argentina	Unidad de Transplante Velez Sarsfield	Cordoba
Argentina	Crai Norte	San Martin	Buenos Aires
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Monash Medical Centre	Clayton	Victoria
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	The Queen Elizabeth Hospital	Woodville	South Australia
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Brazil	Hospital das Clinicas - UNICAMP	Campinas	SP
Brazil	Hipertensao Hospital do Rim e Hipertensao	Sao Paulo	SP
Canada	Foothills Medical Center	Calgary	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Queen II Health and Science Center	Halifax	Nova Scotia
Canada	McGill University Health Centre	Montreal	Quebec
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	University Health Network, The Toronto Hospital	Toronto	Ontario
Germany	Klinikum der Johann Wolfgang Geothe-Universitaet	Frankfurt am Main
Germany	Staedt. Krankenhaus Koeln-Merheim	Koeln
Italy	Ospedale Consorziale e policlinico-Universita degli Studi	Bari	BA
Malaysia	Hospital Kuala Lumpur	Kuala Lumpur
New Zealand	Auckland Hospital	Auckland	Grafton
Singapore	Singapore General Hospital	Singapore
Spain	Hospital de Bellvitge	L'hospitalet de Llobregat
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Central de Asturias	Oviedo
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei	ROC
Taiwan	Chang-Gung Memorial Hospital-Linko	Tao-Yuan	Lin-Ko
United Kingdom	Queen Elizabeth Medical Centre	Edgbaston	Birmingham
United Kingdom	University Hospital of Wales	Heath Park	Cardiff
United Kingdom	Freeman Hospital	High Heaton	Newcastle Upon Tyne
United Kingdom	Guy's Hospital	London
United Kingdom	Nottingham City Hospital	Nottingham
United Kingdom	Walsgrave Hospital NHS Trust	Walsgrave	Coventry
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	Indiana U. Medical Center	Indianapolis	Indiana
United States	U. of Wisconsin Hospital Clinics	Madison	Wisconsin
United States	Loyola Medical Center	Maywood	Illinois
United States	Legacy Research & Technology Ctr.	Portland	Oregon
United States	UCSF Kidney Transplant Service	San Francisco	California
United States	Livelink, Inc.	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  Germany,  Italy,  Malaysia,  New Zealand,  Singapore,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calculated glomerular filtration rate after 12 months treatment
Secondary	Incidence of death, graft loss, biopsy-proven acute rejection after 3 and 12 months.
Secondary	Patient and graft survival after 12 months.
Secondary	Incidence of AEs and SAEs after 3 and 12 months.
Secondary	Blood pressure, lipids and glucose profiles after 3 and 12 months.
Secondary	Percentage of patients free of steroids at 12 months