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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-09-30

Brief Summary

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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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Detailed Description

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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

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Acute Transplant Rejection in Patients Receiving Allogeneic Renal Transplant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Mycophenolate Mofetil

Film Coated Tablet, each tablet contains 500mg Mycophenolate Mofetil

Intervention Type DRUG

Other Intervention Names

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MyOra®

Eligibility Criteria

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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