Observational Registry Study of Renal Transplant Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Kidney Transplant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Enteric coated mycophenolate sodium (EC-MPS) arm

Patients to whom EC-MPS is prescribed by their practitioner.

No interventions assigned to this group

MMF arm

Patients to whom MMF is prescribed by their practitioner.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No