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Freedom Study: Myfortic in Kidney Transplant Patients

This study has been completed.
Information provided by:
Novartis Identifier:
First received: January 12, 2005
Last updated: January 28, 2011
Last verified: January 2011
The primary objective of the study is to evaluate that 3 immunosuppressant regimens will have comparable kidney function results in kidney transplant patients.

Condition Intervention Phase
Kidney Transplantation Drug: Myfortic Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Novartis:

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

Enrollment: 342
Study Start Date: March 2003
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00101738

  Show 44 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Novartis
  More Information

Responsible Party: Novartis Pharmaceuticals, Novartis Identifier: NCT00101738     History of Changes
Other Study ID Numbers: CERL080A2404
Study First Received: January 12, 2005
Last Updated: January 28, 2011

Keywords provided by Novartis:
Kidney Transplantation
Acute rejection
Kidney function

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents processed this record on September 21, 2017