MORE registry
A Phase IV, Non-interventional, Multi-center, Open-label, Prospective, Observational Study of the Safety, Effectiveness, Tolerability and Compliance of Immunosuppressive Regimens Using Mycophenolic Acid to Treat de Novo Renal Transplant Patients in Routine Clinical Practice
Sponsor study identifier
observational
0
1 country
8
Study Start
June 2007
Actual (reported)Primary Completion
May 2010
Actual (reported)Study Completion
May 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2010
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2007
Actual (reported)May 2010
Actual (reported)May 2010
Actual (reported)January 25, 2011
Actual (reported)January 26, 2011
Actual (reported)Dosage of EC-MPS or MMF over time
Dosage interruptions, discontinuations and switches between EC-MPS and MMF
60 months
Incidence of Gastro-Intestinal (GI) Adverse Events (AEs) in relationship with prior GI history and GI co-medications
60 months
The incidence of selected Adverse Events
60 months
Combined outcome measure of biopsy-proven acute rejection (BPAR) episodes, graft loss and death
60 months
Center Practices
60 months
Patients to whom EC-MPS is prescribed by their practitioner.
Patients to whom MMF is prescribed by their practitioner.
This study will enroll approximately 1,200 de novo (newly transplanted within 2 weeks) renal transplant patients from approximately 30-60 transplant centers across the United States. Patients should be consented prior to the first dose of MPA, +/- 14 days from the date of the transplant and be enrolled as soon as feasible after transplantation but not later than 2 weeks post-transplantation. Enrollment targets will be capped globally at 800 patients being treated with myfortic® and 400 patients being treated with CellCept®.
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
0 participants (actual enrollment reported by the registry).
First Submitted
January 25, 2011
First Posted
January 26, 2011
Study Start
June 2007
Actual (reported)Contact the study team to confirm eligibility.
Seattle investigational site
Seattle, Washington, United States
Primary Completion
May 2010
Actual (reported)Study Completion
May 2010
Actual (reported)Last Updated
February 27, 2017
Record last verified: 2017-02
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Source: ClinicalTrials.gov.
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