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Mycophenolate Mofetil (MMF): A Long-Term Data Evaluation

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00203671
First received: September 12, 2005
Last updated: July 12, 2010
Last verified: May 2007
History of Changes
  Purpose

The purposes of this study are:

  • To review past clinical use of mycophenolate mofetil (MMF) in kidney transplant patients;
  • To discover why doses were modified and how those modifications affected the survival and health of the transplanted kidney; and
  • To determine whether, therefore, the side effects of MMF that result in dose alterations are related to outcome.

Condition
Kidney Diseases

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Mycophenolate Mofetil (MMF): A Long-Term Data Evaluation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Enrollment: 651
Study Start Date: April 2006
Study Completion Date: May 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Data from existing medical records of 651 UCLA patients who received a kidney transplant, between the dates of January 1, 1995 - December 31st, 2003 All data was reviewed and analyzed as part of this study.

Criteria

Inclusion Criteria:

  • Renal transplant recipients of either a cadaveric or living donor kidney.
  • 18 years of age or older.

Exclusion Criteria:

  • Multiple organ transplant recipients.
  • Prior kidney transplant recipients.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00203671

Sponsors and Collaborators
University of California, Los Angeles
Novartis Pharmaceuticals
Investigators
Principal Investigator: Alan H Wilkinson, MD University of California, Los Angeles
Study Chair: Ralph Barbeito, Ph.D. Novartis Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00203671     History of Changes
Other Study ID Numbers: 04-05-018-01
Study First Received: September 12, 2005
Last Updated: July 12, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
renal
transplant
kidney
rejection
 MMF
Mycophenolate Mofetil
outcomes
Kidney Transplantation

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

ClinicalTrials.gov processed this record on June 18, 2013