Generic Mycophenolate Mofetil Safety Study for Prophylaxis in de Novo Renal Transplant Patients in Jordan (MyOra-PASS)

Hikma

Status: Completed

Conditions: Acute Transplant Rejection in Patients Receiving Allogeneic Renal Transplant

Treatments: Drug: Mycophenolate Mofetil

Study type: Observational

Funder types: Industry

Identifiers

NCT03517982

MYR-JOR-2013-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Volunteers: No Healthy Volunteers

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®