MYREPTIC-N® or MY-REPT® in Stable Patients After Kidney Transplant Recipients
NCT ID: NCT06044493
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
158 participants
INTERVENTIONAL
2023-11-15
2025-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Myreptic-N Tablet
Mycophenolate sodium
Myreptic-N Tablet
Up to 720mg BID(total 1440mg daily), PO - Check the blood concentration of Mycophenolate at each visit
Myrept Tablet/Capsule
Mycophenolate mofetil
Mycophenolate mofetil Tablet/Capsule
Up to 1g BID(total 2g daily), PO - Check the blood concentration of Mycophenolate at each visit
Interventions
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Myreptic-N Tablet
Up to 720mg BID(total 1440mg daily), PO - Check the blood concentration of Mycophenolate at each visit
Mycophenolate mofetil Tablet/Capsule
Up to 1g BID(total 2g daily), PO - Check the blood concentration of Mycophenolate at each visit
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients who at least 1 year after kidney transplant
3. serum creatinine ≤2.3 mg/dL
4. Patients on immunosuppressive maintenance therapy using combination of Calcineurin Inhibitor and Mycophenolate Mofetil after kidney transplantation
Exclusion Criteria
2. Patients who had discontinued corticosteroid within 4 weeks
3. At the time of Screening
* Treatment with active liver disease or Liver function test(T-bilirubin, AST, ALT)is over 3 times than upper normal limit
* WBC\< 2,500/mm\^3, or platelet \< 75,000/mm\^3, or ANC \< 1,300/ mm\^3
4. In investigator's judgement
19 Years
ALL
No
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Jongwon Ha, MD, PhD
Role: STUDY_CHAIR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, Seoul, South Korea
Countries
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Central Contacts
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Facility Contacts
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Jongwon Ha, MD, PhD
Role: primary
Jung A Lee
Role: backup
Other Identifiers
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B130_01KT2203
Identifier Type: -
Identifier Source: org_study_id