Kidney Transplantation
Conditions
Keywords
Kidney Transplantation, ABO incompatible, Sirolimus
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 De Novo Living Kidney Transplant Recipients.
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 Plus Calcineurin Inhibitors in ABO incompatible De Novo Living Kidney Transplant Recipients.
Interventions
DRUGSirolimus 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.
DRUGMycophenolate Mofetil Cap./Tab.
Up to 1g BID(total 2g daily), PO
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\[Time of Screening\] 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
\[Time of Screening\] 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of composite efficacy failure | Until 48 weeks after taking medicine | Composite efficacy failure include biopsy-confired acute rejection, graft loss, death, or follow-up failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of biopsy-confirmed acute rejection | Until 24weeks and 48weeks after taking medicine | Banff Criteria |
| The pathological results and time of occurrence and method of treatment, result of the treatment of acute rejection confirmed by biopsy | Until 24weeks and 48weeks after taking medicine | Banff Criteria |
| Incidence of composite efficacy failure | Until 24 weeks after taking medicine | Composite efficacy failure include biopsy-confired acute rejection, graft loss, death, or follow-up failure |
| Function of Kidney | Until 24weeks and 48weeks after taking medicine | eGFR using MDRD(Modification of Diet in Renal Disease) method |
| Incidence of CMV, BKV infection | Until 24weeks and 48weeks after taking medicine | Incidence of CMV, BKV infection |
| Survival rate | Until 24weeks and 48weeks after taking medicine | transplanted organ and patients |
Countries
South Korea
Contacts
Primary ContactKyu Ha Huh, M.D, Ph.D
Backup ContactJung A Lee
Outcome results
None listed