Generic Mycophenolate Mofetil Safety Study for Prophylaxis in de Novo Renal Transplant Patients in Jordan
Generic Mycophenolate Mofetil Safety Study for Prophylaxis in de Novo Renal Transplant Patients in Jordan
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.
Inclusion Criteria:

 -  Patient received de novo renal transplant

 -  Patient treated with MyOra® according to the attending physician's judgment (either
 post-transplant or induction)

 -  Patient provided written informed consent

 Exclusion Criteria:

 -  Hypersensitivity to mycophenolate mofetil, mycophenolic acid (MPA) or any of the
 constituents of MyOra®