Freedom Study: Myfortic in Kidney Transplant Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00101738
Recruitment Status : Completed
First Posted : January 13, 2005
Last Update Posted : January 31, 2011
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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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: Myfortic Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 342 participants
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
Study Start Date : March 2003
Actual Primary Completion Date : May 2005
Actual Study Completion Date : May 2005

Primary Outcome Measures :
  1. Calculated glomerular filtration rate after 12 months treatment

Secondary Outcome Measures :
  1. Incidence of death, graft loss, biopsy-proven acute rejection after 3 and 12 months.
  2. Patient and graft survival after 12 months.
  3. Incidence of AEs and SAEs after 3 and 12 months.
  4. Blood pressure, lipids and glucose profiles after 3 and 12 months.
  5. Percentage of patients free of steroids at 12 months

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00101738

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Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Novartis

Responsible Party: Novartis Pharmaceuticals, Novartis Identifier: NCT00101738     History of Changes
Other Study ID Numbers: CERL080A2404
First Posted: January 13, 2005    Key Record Dates
Last Update Posted: January 31, 2011
Last Verified: January 2011

Keywords provided by Novartis:
Kidney Transplantation
Acute rejection
Kidney function

Additional relevant MeSH terms:
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action