Clinical trial NCT04700709: Efficacy and Safety of Sirolimus Plus CNI Compared With MMF Plus CNI in ABO-i Kidney Transplant Recipients.
Official title: 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. [ART Study]
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Kidney Transplantation
Keywords: Kidney Transplantation
ABO incompatible
Sirolimus
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2021-01-08
Enrollment: 158
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of composite efficacy failure
timeFrame: Until 48 weeks after taking medicine
Secondary outcomes:
measure: Incidence of composite efficacy failure
timeFrame: Until 24 weeks after taking medicine
measure: Incidence of biopsy-confirmed acute rejection
timeFrame: Until 24weeks and 48weeks after taking medicine
measure: The pathological results and time of occurrence and method of treatment, result of the treatment of acute rejection confirmed by biopsy
timeFrame: Until 24weeks and 48weeks after taking medicine
measure: Survival rate
timeFrame: Until 24weeks and 48weeks after taking medicine
measure: Function of Kidney
timeFrame: Until 24weeks and 48weeks after taking medicine
measure: Incidence of CMV, BKV infection
timeFrame: Until 24weeks and 48weeks after taking medicine
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Kyu Ha Huh, M.D, Ph.D
role: STUDY_CHAIR
References: