The purpose of this observational study was to assess the safety and efficacy of generic mycophenolate mofetil in de novo renal transplant patients in Jordan where no visits or intervention(s) additional to the daily practice were performed.
A single center, observational, open-label, longitudinal, prospective study combined with retrospective data collection for 12 de novo renal transplant patients. Ten patients were prospectively followed for 12 months after receiving MyOra® (mycophenolate mofetil) and two patients were previously on MyOra® (mycophenolate mofetil), thus their data was retrospectively collected from their hospital records and all relevant workup tests results. Outcomes include occurrence of AEs and proportion of patients with normal graft function.
Study Type
OBSERVATIONAL
Enrollment
12
Film Coated Tablet, each tablet contains 500mg Mycophenolate Mofetil
Prince Hamza Hospital
Amman, Jordan
Incidence, severity and relationship of adverse events (AEs) to the Study medication
Rate of AEs, SAEs and laboratory tests abnormalities will be calculated
Time frame: 12 months
Proportion of patients with normal graft function
Graft status was estimated through the evaluation of kidney function in all patients enrolled in the study
Time frame: 12 months
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