Observational Registry Study of Renal Transplant Patients (MORE registry)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||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|
- Dosage of EC-MPS or MMF over time [ Time Frame: 60 months ] [ Designated as safety issue: No ]Dosage interruptions, discontinuations and switches between EC-MPS and MMF
- Incidence of Gastro-Intestinal (GI) Adverse Events (AEs) in relationship with prior GI history and GI co-medications [ Time Frame: 60 months ] [ Designated as safety issue: No ]
- The incidence of selected Adverse Events [ Time Frame: 60 months ] [ Designated as safety issue: No ]e.g., viral infections, hematological events, glaucoma, malignancy, diabetes mellitus, cardiovascular events, bone-loss related events, GI events, hepatitis) and associated Serious Adverse Events (SAEs).
- Combined outcome measure of biopsy-proven acute rejection (BPAR) episodes, graft loss and death [ Time Frame: 60 months ] [ Designated as safety issue: No ]
- Center Practices [ Time Frame: 60 months ] [ Designated as safety issue: No ]The center practice will be described as observed. This includes the number of transplants performed per year per center, patient follow up frequency, performance of protocol biopsies, use of induction therapies and MPA monitoring.
|Study Start Date:||June 2007|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Enteric coated mycophenolate sodium (EC-MPS) arm
Patients to whom EC-MPS is prescribed by their practitioner.
Patients to whom MMF is prescribed by their practitioner.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284257
|United States, California|
|San Francisco investigational site|
|San Francisco, California, United States|
|United States, Colorado|
|Denver Investigational site|
|Denver, Colorado, United States|
|United States, Massachusetts|
|Springfield investigational site|
|Springfield, Massachusetts, United States|
|United States, Michigan|
|Detroit investigational site|
|Detroit, Michigan, United States|
|United States, New York|
|New York investigational site|
|New York, New York, United States|
|United States, Pennsylvania|
|PHILADELPHIA investigational site|
|Philadelphia, Pennsylvania, United States|
|United States, Vermont|
|BURLINGTON investigational site|
|Burlington, Vermont, United States|
|United States, Washington|
|Seattle investigational site|
|Seattle, Washington, United States|