NCT03517982

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 8, 2018

Completed
Last Updated

May 8, 2018

Status Verified

April 1, 2018

Enrollment Period

1.9 years

First QC Date

April 25, 2018

Last Update Submit

April 25, 2018

Conditions

Acute Transplant Rejection in Patients Receiving Allogeneic Renal Transplant

Keywords

MyOraMycophenolate MofetilEnd stage renal diseaseDe novo Renal transplantPost authorization safety studyImmunosuppressantCohort study

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Proportion of patients with normal graft function

    12 months

Interventions

Mycophenolate MofetilDRUG

Film Coated Tablet, each tablet contains 500mg Mycophenolate Mofetil

Also known as: MyOra®

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients were enrolled from a single public hospital in Jordan

You may qualify if:

  • 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

You may not qualify if:

  • Hypersensitivity to mycophenolate mofetil, mycophenolic acid (MPA) or any of the constituents of MyOra®

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince Hamza Hospital

Amman, Jordan

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Mycophenolic Acid

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipids

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2018

First Posted

May 8, 2018

Study Start

October 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

May 8, 2018

Record last verified: 2018-04

Locations

JO(1)