Acute Transplant Rejection in Patients Receiving Allogeneic Renal TransplantMyOra-PASSNCT03517982
Generic Mycophenolate Mofetil Safety Study for Prophylaxis in de Novo Renal Transplant Patients in Jordan
An observational study of Acute Transplant Rejection in Patients Receiving Allogeneic Renal Transplant, run by Hikma Pharmaceuticals LLC at 1 site in Jordan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Transplant Rejection in Patients Receiving Allogeneic Renal Transplant
- What is being tested?
- Mycophenolate Mofetil
- Type of treatment
- Pill or oral medicine
- How many people
- 12 participants
- Where
- 1 siteJordan
- Study dates
- Oct 2014to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients were enrolled from a single public hospital in Jordan
Who may be able to join
- 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
Who cannot join
- Hypersensitivity to mycophenolate mofetil, mycophenolic acid (MPA) or any of the constituents of MyOra®
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MyOra® (Mycophenolate Mofetil) Post-Authorization Safety Study for Prophylaxis in de Novo Renal Transplant Patients
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.
Read the detailed 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.
- Being tested
- Mycophenolate Mofetil
- Keywords
- MyOra, Mycophenolate Mofetil, End stage renal disease, De novo Renal transplant, Post authorization safety study, Immunosuppressant, Cohort study
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called MyOra®
Film Coated Tablet, each tablet contains 500mg Mycophenolate Mofetil
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity and relationship of adverse events (AEs) to the Study medication
Rate of AEs, SAEs and laboratory tests abnormalities will be calculated
Measured: 12 months
Secondary outcomes (1)
Proportion of patients with normal graft function
Graft status was estimated through the evaluation of kidney function in all patients enrolled in the study
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study startOct 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Transplant Rejection in Patients Receiving Allogeneic Renal TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hikma Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517982
- Sponsor's protocol ID
- MYR-JOR-2013-04
- Acronym
- MyOra-PASS
- Status last verified
- Apr 2018
- First submitted
- 25 Apr 2018
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyOra® (Mycophenolate Mofetil) Post-Authorization Safety Study for Prophylaxis in de Novo Renal Transplant Patients
- ClinicalTrials.gov ID
- NCT03517982
- Acronym / sponsor ID
- MyOra-PASS / MYR-JOR-2013-04
- Keywords
- MyOra, Mycophenolate Mofetil, End stage renal disease, De novo Renal transplant, Post authorization safety study, Immunosuppressant, Cohort study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hikma Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2014 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 8 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients were enrolled from a single public hospital in Jordan
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Hypersensitivity to mycophenolate mofetil, mycophenolic acid (MPA) or any of the constituents of MyOra®
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mycophenolate MofetilAlso: MyOra®Film Coated Tablet, each tablet contains 500mg Mycophenolate Mofetil | Drug | – |
Primary outcome
Incidence, severity and relationship of adverse events (AEs) to the Study medication
Time frame: 12 months
Rate of AEs, SAEs and laboratory tests abnormalities will be calculated
1 secondary outcome
Proportion of patients with normal graft function
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Transplant Rejection in Patients Receiving Allogeneic Renal Transplant, run by Hikma Pharmaceuticals LLC at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, severity and relationship of adverse events (AEs) to the Study medication (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.