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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03517982

Acronym

MyOra-PASS

Enrollment

Registered

2018-05-08

Start date

2014-10-31

Completion date

2016-09-30

Last updated

2018-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Transplant Rejection in Patients Receiving Allogeneic Renal Transplant

Keywords

MyOra, Mycophenolate Mofetil, End stage renal disease, De novo Renal transplant, Post authorization safety study, Immunosuppressant, Cohort study

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.

Interventions

DRUGMycophenolate Mofetil

Film Coated Tablet, each tablet contains 500mg Mycophenolate Mofetil

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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®

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Jordan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026