Kidney TransplantationPhase 4My-Rept_KT_P4NCT01842269
Evaluate the Efficacy and Safety of My-Rept® Tablet vs. My-Rept® Capsule in Combination With Tacrolimus in Kidney Transplant Patients
A Phase 4 study testing Mycophenolate Mofetil 500mg and Mycophenolate Mofetil 250mg in people with Kidney Transplantation, run by Chong Kun Dang Pharmaceutical at 11 sites in South Korea.
Trial summary
Efficacy and Safety of My-Rept® Tablet(Mycophenolate Mofetil 500mg/Tab.) versus My-Rept® Capsule(Mycophenolate Mofetil 250mg/Cap.) in Combination with Tacrolimus in Kidney Transplant Patients Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Mycophenolate Mofetil 500mg and Mycophenolate Mofetil 250mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 11 sitesSouth Korea
- Study dates
- Jan 2013to Apr 2015
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20 years or older.
- Patient who receive primary or secondary kidney transplantation from living or brain-dead donor .
- Patient who receive age 20 years or older donor.
- Willing and able to provide written informed consent.
Who cannot join
- Cold Ischemia Time > 30 hours.
- Patient who receive HLA-identical donor.
- Patient with dual kidney transplantation recipient or have history of other organ transplantation in past or current.
- Patient who receive extra-renal solid organ or bone marrow stem cell transplantation.
- Patient who receive kidney transplantation from non-heart beating cadaveric donor(organ donor after cardiac death
- Patient who receive kidney transplantation from ABO blood type mismatching donor or lymphocyte cross matching (LCM) positive donor.
Show all 19Show fewer
- Patient with cancer within 5 years, except cured skin cancer patient(Squamous cell or basal cell carcinoma)
- Positive in serology test(HIV, HBsAg, HCV) in recipients and/or donor.
- Patient with Severe gastrointestinal disease in screening period by investigator's decision.
- Patient with systemic severe infection requiring treatment (able to transplantation after completely disappear or is controlled infection)
- Liver cirrhosis, clinically significant portal hypertension or other moderate to severe liver disease.
- Defined by the following laboratory parameters before screening period
- One of liver function test(AST, ALT, ALP, Total Bilirubin)results increased more than 3 times upper limit of normal range
- WBC <2,500/mm3, Platelet <75,000/mm3
- Acute (within 4 weeks) or chronic(need to treatments) allergic/hypersensitivity reaction in the history of Investigational drugs (ex, mycophenolate acid or tacrolimus, etc.) or additives.
- Administration of other Investigational drugs and/or immunosuppressants within 28days before screening period (except allowed immunosuppressants in protocol)
- Women in pregnant or breast-feeding or don't using adequate contraception.
- Patient has conversation impairment because alcohol or drugs addiction history within 6months or mental illness, etc.
- In investigator's judgment
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
South Korea11 sites
Maryknoll Medical Center
Busan
Kyungpook National University Hospital
Daegu
Yeungnam University Medical Center
Daegu
Wonkwang University School of Medical & Hospital
Iksan
Chunbuk National University Hospital
Jeonju
Bundang CHA Medical Center
Seongnam
Gangnam Severance Hospital
Seoul
Kandong Sacred Heart Hospital
Seoul
Severance Hospital
Seoul
Ajou University Hospital
Suwan
Ulsan University Hospital
Ulsan
About this study
Official title: Open Label, Randomized, Multi-center, Phase 4 Trial to Evaluate the Efficacy and Safety of My-Rept® Tablet(Mycophenolate Mofetil 500mg/Tab.) Versus My-Rept® Capsule(Mycophenolate Mofetil 250mg/Cap.) in Combination With Tacrolimus for 26 Weeks in Kidney Transplant Patients
Efficacy and Safety of My-Rept® Tablet(Mycophenolate Mofetil 500mg/Tab.) versus My-Rept® Capsule(Mycophenolate Mofetil 250mg/Cap.) in Combination with Tacrolimus in Kidney Transplant Patients
- Conditions
- Kidney Transplantation
- Being tested
- Mycophenolate Mofetil 500mg, Mycophenolate Mofetil 250mg
- Keywords
- Mycophenolate Mofetil, MMF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycophenolate Mofetil 500mgDrug
Also called My-Rept® Tablet
Mycophenolate Mofetil 250mgDrug
Also called My-Rept® Capsule
| Study group | Role | What they receive |
|---|---|---|
| My-Rept® Tablet | Experimental | My-Rept® Tablet, Mycophenolate Mofetil 500mg, orally Receives: Drug: Mycophenolate Mofetil 500mg |
| My-Rept® Capsule | Active comparator | My-Rept® Capsule, Mycophenolate Mofetil 250mg, orally Receives: Drug: Mycophenolate Mofetil 250mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of efficacy failure
efficacy failure=acute rejection by kidney biopsy,graft loss, death
Measured: up to 26 weeks
Secondary outcomes (4)
Rate of acute rejection by kidney biopsy
Measured: up to 26 weeks
Survival with no graft loss
Measured: up to 26 weeks
eGFR(using by MDRD method)
Measured: up to 26 weeks
Number of Participants with Adverse Events
- Rate of adverse events
- Evaluated safety parameters included: Physical examination, laboratory test, etc.
Measured: up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yu Seun Kim, Ph. D, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842269
- Sponsor's protocol ID
- 223KTP12003
- Acronym
- My-Rept_KT_P4
- Status last verified
- Aug 2015
- First submitted
- 25 Apr 2013
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Randomized, Multi-center, Phase 4 Trial to Evaluate the Efficacy and Safety of My-Rept® Tablet(Mycophenolate Mofetil 500mg/Tab.) Versus My-Rept® Capsule(Mycophenolate Mofetil 250mg/Cap.) in Combination With Tacrolimus for 26 Weeks in Kidney Transplant Patients
- ClinicalTrials.gov ID
- NCT01842269
- Acronym / sponsor ID
- My-Rept_KT_P4 / 223KTP12003
- Conditions
- Kidney Transplantation
- Keywords
- Mycophenolate Mofetil, MMF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 29 Apr 2013 (estimated)
- 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.
Efficacy and Safety of My-Rept® Tablet(Mycophenolate Mofetil 500mg/Tab.) versus My-Rept® Capsule(Mycophenolate Mofetil 250mg/Cap.) in Combination with Tacrolimus in Kidney Transplant Patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| My-Rept® Tablet | Experimental | Drug: Mycophenolate Mofetil 500mgMy-Rept® Tablet, Mycophenolate Mofetil 500mg, orally |
| My-Rept® Capsule | Active comparator | Drug: Mycophenolate Mofetil 250mgMy-Rept® Capsule, Mycophenolate Mofetil 250mg, orally |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 20 years or older.
- Patient who receive primary or secondary kidney transplantation from living or brain-dead donor .
- Patient who receive age 20 years or older donor.
- Willing and able to provide written informed consent.
Key exclusion criteria (19 listed)
- Cold Ischemia Time > 30 hours.
- Patient who receive HLA-identical donor.
- Patient with dual kidney transplantation recipient or have history of other organ transplantation in past or current.
- Patient who receive extra-renal solid organ or bone marrow stem cell transplantation.
- Patient who receive kidney transplantation from non-heart beating cadaveric donor(organ donor after cardiac death
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 Mofetil 500mgAlso: My-Rept® Tablet | Drug | My-Rept® Tablet |
| Mycophenolate Mofetil 250mgAlso: My-Rept® Capsule | Drug | My-Rept® Capsule |
Primary outcome
Rate of efficacy failure
Time frame: up to 26 weeks
efficacy failure=acute rejection by kidney biopsy,graft loss, death
4 secondary outcomes
Rate of acute rejection by kidney biopsy
Time frame: up to 26 weeks
Survival with no graft loss
Time frame: up to 26 weeks
eGFR(using by MDRD method)
Time frame: up to 26 weeks
Number of Participants with Adverse Events
Time frame: up to 26 weeks
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 19 Aug 2015.
Related trials for Kidney Transplantation
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Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
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Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
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Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
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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.
Yu Seun Kim, Ph. D principal investigator
Severance Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mycophenolate Mofetil 500mg and Mycophenolate Mofetil 250mg in people with Kidney Transplantation, run by Chong Kun Dang Pharmaceutical at 11 sites in South Korea.
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 4 inclusion and 19 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 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Rate of efficacy failure (time frame: up to 26 weeks). 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 19 Aug 2015.