Observational Registry Study of Renal Transplant Patients

Withdrawn before enrolling

Conditions studied: Kidney Transplant

In brief

The MORE Observational Study follows real-world renal transplant patients with the data resolution of a monitored, prospective clinical trial for 5 years. In addition to capturing detailed clinical data, the study describes recent important changes in surveillance testing and drug therapy and relates these changes to short and long-term outcomes. Also, the study measures patient compliance over time and details the rationale for modifications of MPA dosing in maintenance and regimen changes after episodes of AR. The MORE study will provide information on era changes in transplant practices and their impact on clinical outcome, new insights on optimizing regimens for discrete patient subsets and new perspectives on the optimal use of MPA therapy.

Key facts

Study ID

NCT01284257

Run by

Novartis Pharmaceuticals

People needed

0

Starts

2007-06-01

Expected to finish

2010-05-01

Last updated by the study team

2017-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older.
• The de novo recipient of a cadaveric or living donor kidney transplant, within two weeks of transplantation.
• Receiving mycophenolic acid (MPA) therapy of either myfortic® or CellCept®.
• Able to provide informed consent.
• Able to self-administer the ITAS compliance instrument (6 questions).

You may not qualify if…

• The recipient of multiple organ grafts or prior non-kidney graft.
• Enrolled or plans to enroll in an investigational clinical trial.
• Not likely to have up to 5 year follow-up data available for this study.

Where it is running

• San Francisco investigational site — San Francisco, California, United States
• Denver Investigational site — Denver, Colorado, United States
• Springfield investigational site — Springfield, Massachusetts, United States
• Detroit investigational site — Detroit, Michigan, United States
• New York investigational site — New York, New York, United States
• PHILADELPHIA investigational site — Philadelphia, Pennsylvania, United States
• BURLINGTON investigational site — Burlington, Vermont, United States
• Seattle investigational site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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