An observational study in Kidney Transplant, sponsored by Novartis Pharmaceuticals. Withdrawn at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-27.
Sponsored by Novartis Pharmaceuticals · Observational
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.
Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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®.
Exclusion Criteria:
Patients to whom EC-MPS is prescribed by their practitioner.
Patients to whom MMF is prescribed by their practitioner.
Dosage of EC-MPS or MMF over time
Dosage interruptions, discontinuations and switches between EC-MPS and MMF
Time frame: 60 months
Incidence of Gastro-Intestinal (GI) Adverse Events (AEs) in relationship with prior GI history and GI co-medications
Time frame: 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).
Time frame: 60 months
Combined outcome measure of biopsy-proven acute rejection (BPAR) episodes, graft loss and death
Time frame: 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.
Time frame: 60 months
This study is withdrawn, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals