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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03517982
• Date of registration: 25/04/2018
• Prospective Registration: No
• Primary sponsor: Hikma Pharmaceuticals LLC
• Public title: Generic Mycophenolate Mofetil Safety Study for Prophylaxis in de Novo Renal Transplant Patients in Jordan MyOra-PASS
• Scientific title: MyOra® (Mycophenolate Mofetil) Post-Authorization Safety Study for Prophylaxis in de Novo Renal Transplant Patients
• Date of first enrolment: October 2014
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03517982
• Study type: Observational

Countries of recruitment

Jordan

Key inclusion & exclusion criteria

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®



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Acute Transplant Rejection in Patients Receiving Allogeneic Renal Transplant

Intervention(s)

Drug: Mycophenolate Mofetil

Primary Outcome(s)

Incidence, severity and relationship of adverse events (AEs) to the Study medication [Time Frame: 12 months]

Secondary Outcome(s)

Proportion of patients with normal graft function [Time Frame: 12 months]

Secondary ID(s)

MYR-JOR-2013-04

Source(s) of Monetary Support

Please refer to primary and secondary sponsors