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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms

  • Acute Transplant Rejection in Patients Receiving Allogeneic Renal Transplant

NCT number NCT03517982
Study type Observational
Source Hikma Pharmaceuticals LLC
Contact
Status Completed
Phase
Start date October 2014
Completion date September 2016