Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Dosage of EC-MPS or MMF over time | Dosage interruptions, discontinuations and switches between EC-MPS and MMF | 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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®.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco investigational site | San Francisco | California | United States | |||
| Denver Investigational site |
Not provided
Not provided
Not provided
Not provided
| 60 months |
| Combined outcome measure of biopsy-proven acute rejection (BPAR) episodes, graft loss and death | 60 months |
| Center Practices | 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. | 60 months |
| 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 |