NCT00203671

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
651

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

July 13, 2010

Status Verified

May 1, 2007

First QC Date

September 12, 2005

Last Update Submit

July 12, 2010

Conditions

Kidney Diseases

Keywords

renaltransplantkidneyrejectionMMFMycophenolate MofetiloutcomesKidney Transplantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Multiple organ transplant recipients.
  • Prior kidney transplant recipients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney DiseasesRejection, Psychology

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSocial BehaviorBehavior

Study Officials

  • Alan H Wilkinson, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

  • Ralph Barbeito, Ph.D.

    Novartis Pharmaceuticals

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

April 1, 2006

Study Completion

May 1, 2007

Last Updated

July 13, 2010

Record last verified: 2007-05