Study to Compare the Efficacy and Safety After Conversion to RaparoBell® or My-Rept® in Kidney Transplant Patients
NCT ID: NCT05193565
Last Updated: 2022-02-01
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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UNKNOWN
PHASE4
206 participants
INTERVENTIONAL
2021-11-19
2024-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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RaparoBell Tablet
RaparoBell Tablet
Sirolimus
Orally, once-daily in the morning - Check the blood concentration of Sirolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 3\~8ng/mL
Mycophenolate Mofetil Tablet/Capsule
Myrept Tablet/Capsule
Mycophenolate mofetil
Up to 1g BID(total 2g daily), PO
Interventions
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Sirolimus
Orally, once-daily in the morning - Check the blood concentration of Sirolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 3\~8ng/mL
Mycophenolate mofetil
Up to 1g BID(total 2g daily), PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Over 20 years old
3. Patients on immunosuppressive maintenance therapy using combination of Calcineurin Inhibitor and Mycophenolic acid after kidney transplantation
Exclusion Criteria
2. 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
* Protein/Creatinine ratio≥1.0(mg/mg)
3. Patents who had a record of taking mTOR inhibitor before 3 months
4. In investigator's judgement
20 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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Chul Woo Yang, Ph.D
Role: STUDY_CHAIR
The Catholic University of Korea
Locations
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The Catholic University of Korea, Seoul, St.Mary's Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Other Identifiers
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B110_02KT2103
Identifier Type: -
Identifier Source: org_study_id
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