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

Acute Transplant Rejection in Patients Receiving Allogeneic Renal Transplant Clinical Trial

— MyOra-PASS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03517982
• Other study ID #: MYR-JOR-2013-04
• Status: Completed
• Start date: October 2014
• Est. completion date: September 2016

Study information

• Verified date: April 2018
• Source: Hikma Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Gender: All
• Age group: N/A and older

Eligibility

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®

Related Conditions & MeSH terms

• Acute Transplant Rejection in Patients Receiving Allogeneic Renal Transplant

Intervention

Drug:
• Mycophenolate Mofetil
Film Coated Tablet, each tablet contains 500mg Mycophenolate Mofetil

Locations

Country	Name	City	State
Jordan	Prince Hamza Hospital	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Hikma Pharmaceuticals LLC

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence, severity and relationship of adverse events (AEs) to the Study medication	Rate of AEs, SAEs and laboratory tests abnormalities will be calculated	12 months
Secondary	Proportion of patients with normal graft function	Graft status was estimated through the evaluation of kidney function in all patients enrolled in the study	12 months