NCT03517982

Generic Mycophenolate Mofetil Safety Study for Prophylaxis in de Novo Renal Transplant Patients in Jordan

MyOra® (Mycophenolate Mofetil) Post-Authorization Safety Study for Prophylaxis in de Novo Renal Transplant Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 12 (actual)
• Sponsor: Hikma Pharmaceuticals LLC · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

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.

Detailed 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.

Conditions

• Acute Transplant Rejection in Patients Receiving Allogeneic Renal Transplant

Interventions

Type	Name	Description
DRUG	Mycophenolate Mofetil	Film Coated Tablet, each tablet contains 500mg Mycophenolate Mofetil

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2018-05-08
• Last updated: 2018-05-08

Locations

1 site across 1 country: Jordan