Freedom Study: Myfortic in Kidney Transplant Patients

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

Conditions

Kidney Transplantation

Study Type

Interventional

Study Design

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• Calculated glomerular filtration rate after 12 months treatment

Secondary Outcome Measures:

• 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

Study Start

January 2002

Eligibility & Criteria

• Ages Eligible for Study: 18 Years – 75 Years
• Genders Eligible for Study: Both

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.

Total Enrolment

330

Contact Details

Novartis Pharaceuticals

• 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