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Completed

NCT Number: NCT03517982

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.

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Key information

Conditions

Acute Transplant Rejection in Patients Receiving Allogeneic Renal Transplant Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince Hamza Hospital

Amman, Jordan

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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®

Treatment and study plan

Mycophenolate mofetil

Drug

Film Coated Tablet, each tablet contains 500mg Mycophenolate Mofetil

Other names: MyOra®

Primary outcomes

  1. Incidence, severity and relationship of adverse events (AEs) to the Study medication

    Time frame: 12 months

    Rate of AEs, SAEs and laboratory tests abnormalities will be calculated

Secondary outcomes

  1. Proportion of patients with normal graft function

    Time frame: 12 months

    Graft status was estimated through the evaluation of kidney function in all patients enrolled in the study

Sponsors and collaborators

Lead sponsor

Hikma Pharmaceuticals LLC

Industry

Registry information

Official study title

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

Acronym: MyOra-PASS

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 8, 2018
Registry last updated
May 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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