Efficacy and Safety of Sirolimus Plus CNI Compared With MMF Plus CNI in ABO-i Kidney Transplant Recipients.
NCT ID: NCT04700709
Last Updated: 2021-01-08
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
158 participants
INTERVENTIONAL
2021-01-31
2025-01-31
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
ABO-i De novo Living Kidney transplant recipients will be randomized after Kidney transplant.
Sirolimus Tab.
Orally, once-daily in the morning - The first dose is administered within maximum 6mg/day according to the investigator's judgement, check the blood concentration of Sirolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3\~8ng/ml.
Mycophenolate Mofetil Tablet/Capsule
ABO-i De novo Living Kidney transplant recipients will be randomized after Kidney transplant.
Mycophenolate Mofetil Cap./Tab.
Up to 1g BID(total 2g daily), PO
Interventions
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Sirolimus Tab.
Orally, once-daily in the morning - The first dose is administered within maximum 6mg/day according to the investigator's judgement, check the blood concentration of Sirolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3\~8ng/ml.
Mycophenolate Mofetil Cap./Tab.
Up to 1g BID(total 2g daily), PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Patients who plan to be transplanted ABO incompatible living donor kidney or not past 35 days after kidney transplantation
2. More than the age of 19 years old
3. Agreement with written informed consent
\[Time of Randomization\]
1. Patients who have transplanted Kidney within 4 weeks(25 days to 35 days)
2. Patients who take CNI plus MMF after kidney transplantation
Exclusion Criteria
1. Patients who have transplanted non-kidney organs or have plan to be transplanted non-kidney organs
2. PRA \> 50% before desenitization or positive results of DSA
3. Receive a kidney from a related donor who showed HLA identical
4. Positive in serology test(HIV, HBsAg, HCV) in recipients and/or donor
5. Allergic/hypersensitivity reaction in the history of Investigational drugs or additives
6. Women who are pregnant or breast feeding or not agree to the proper use of contraception during the trial
7. Patient has conversation impairment because of mental illness within 6months
8. Participated in other trial within 4 weeks
9. In investigator's judgement
\[Time of Randomization\]
1. Patients with acute rejection who have been clinically treated after kidney transplantation
2. At the time of Randomization
* 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
3. Patients who had plasmapheresis within 1 week
4. Patents who had a record of taking mTOR inhibitor before
5. 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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Kyu Ha Huh, M.D, Ph.D
Role: STUDY_CHAIR
Severance Hospital
Locations
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Severance Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Other Identifiers
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B110_01KT2002
Identifier Type: -
Identifier Source: org_study_id
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