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Freedom Study: Myfortic in Kidney Transplant Patients

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00101738
First received: January 12, 2005
Last updated: January 28, 2011
Last verified: January 2011
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00101738

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

No publications provided

Responsible Party: Novartis Pharmaceuticals, Novartis
ClinicalTrials.gov Identifier: NCT00101738     History of Changes
Other Study ID Numbers: CERL080A2404
Study First Received: January 12, 2005
Last Updated: January 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
MPA
Kidney Transplantation
Acute rejection
Kidney function

Additional relevant MeSH terms:
Mycophenolic Acid
Mycophenolate mofetil
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013