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

Completed

• Conditions: Acute Transplant Rejection in Patients Receiving Allogeneic Renal Transplant

• Registration Number: NCT03517982
• Lead Sponsor: Hikma Pharmaceuticals LLC

Brief 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.

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2018-04
• Study First Submitted: 2018-04-25
• Study First Submitted QC: 2018-04-25
• Last Update Submitted: 2018-04-25
• Study First Posted: 2018-05-08
• Last Update Posted: 2018-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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®

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence, severity and relationship of adverse events (AEs) to the Study medication	12 months	Rate of AEs, SAEs and laboratory tests abnormalities will be calculated

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with normal graft function	12 months	Graft status was estimated through the evaluation of kidney function in all patients enrolled in the study

Trial Locations

Locations (1)

Prince Hamza Hospital; 🇯🇴 Amman, Jordan