Observational Registry Study of Renal Transplant Patients
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
1 other identifier
observational
N/A
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2007
Typical duration for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 25, 2011
CompletedFirst Posted
Study publicly available on registry
January 26, 2011
CompletedFebruary 27, 2017
February 1, 2017
2.9 years
January 25, 2011
February 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dosage of EC-MPS or MMF over time
Dosage interruptions, discontinuations and switches between EC-MPS and MMF
60 months
Secondary Outcomes (4)
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
Study Arms (2)
Enteric coated mycophenolate sodium (EC-MPS) arm
Patients to whom EC-MPS is prescribed by their practitioner.
MMF arm
Patients to whom MMF is prescribed by their practitioner.
Eligibility Criteria
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®.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
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
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2011
First Posted
January 26, 2011
Study Start
June 1, 2007
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
February 27, 2017
Record last verified: 2017-02