Status:
UNKNOWN
Efficacy and Safety of Sirolimus Plus CNI Compared With MMF Plus CNI in ABO-i Kidney Transplant Recipients.
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Kidney Transplantation
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of RaparoBell® Tablet Plus Calcineurin Inhibitors Compared with Mycophenolate Mofetil Plus Calcineurin Inhibitors in ABO incompatible D...
Detailed Description
This study is Multi-center, Open-label, Randomized Controlled Phase 4 Study to Evaluate the Efficacy and Safety of RaparoBell® Tablet Plus Calcineurin Inhibitors Compared with Mycophenolate Mofetil Pl...
Eligibility Criteria
Inclusion
- \[Time of Screening\]
- Patients who plan to be transplanted ABO incompatible living donor kidney or not past 35 days after kidney transplantation
- More than the age of 19 years old
- Agreement with written informed consent
- \[Time of Randomization\]
- Patients who have transplanted Kidney within 4 weeks(25 days to 35 days)
- Patients who take CNI plus MMF after kidney transplantation
Exclusion
- \[Time of Screening\]
- Patients who have transplanted non-kidney organs or have plan to be transplanted non-kidney organs
- PRA \> 50% before desenitization or positive results of DSA
- Receive a kidney from a related donor who showed HLA identical
- Positive in serology test(HIV, HBsAg, HCV) in recipients and/or donor
- Allergic/hypersensitivity reaction in the history of Investigational drugs or additives
- Women who are pregnant or breast feeding or not agree to the proper use of contraception during the trial
- Patient has conversation impairment because of mental illness within 6months
- Participated in other trial within 4 weeks
- In investigator's judgement
- \[Time of Randomization\]
- Patients with acute rejection who have been clinically treated after kidney transplantation
- 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
- Patients who had plasmapheresis within 1 week
- Patents who had a record of taking mTOR inhibitor before
- In investigator's judgement
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT04700709
Start Date
January 1 2021
End Date
January 1 2025
Last Update
January 8 2021
Active Locations (1)
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1
Severance Hospital
Seoul, South Korea