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Efficacy and Safety of Sirolimus Plus CNI Compared With MMF Plus CNI in ABO-i Kidney Transplant Recipients.

Sponsor
Chong Kun Dang Pharmaceutical (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04700709
Collaborator
(none)
158
Enrollment
1
Location
2
Arms
48
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sirolimus Tab.
  • Drug: Mycophenolate Mofetil Cap./Tab.
 Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
158 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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]
Anticipated Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: RaparoBell® Tablet

ABO-i De novo Living Kidney transplant recipients will be randomized after Kidney transplant.

Drug: 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.
Other Names:
  • RaparoBell® Tab.

    		•
    Active Comparator: Mycophenolate Mofetil Tablet/Capsule

    ABO-i De novo Living Kidney transplant recipients will be randomized after Kidney transplant.

    Drug: Mycophenolate Mofetil Cap./Tab.
    Up to 1g BID(total 2g daily), PO
    Other Names:
  • Myrept® Cap./Tab.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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

    2. Incidence of biopsy-confirmed acute rejection [Until 24weeks and 48weeks after taking medicine]

      Banff Criteria

    3. 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

    4. Survival rate [Until 24weeks and 48weeks after taking medicine]

      transplanted organ and patients

    5. Function of Kidney [Until 24weeks and 48weeks after taking medicine]

      eGFR using MDRD(Modification of Diet in Renal Disease) method

    6. Incidence of CMV, BKV infection [Until 24weeks and 48weeks after taking medicine]

      Incidence of CMV, BKV infection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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/mm3, or platelet < 75,000/mm3, or ANC < 1,300/mm^3

    1. Patients who had plasmapheresis within 1 week

    2. Patents who had a record of taking mTOR inhibitor before

    3. In investigator's judgement

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Severance Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Chong Kun Dang Pharmaceutical

    Investigators

    • Study Chair: Kyu Ha Huh, M.D, Ph.D, Severance Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chong Kun Dang Pharmaceutical
    ClinicalTrials.gov Identifier:
    NCT04700709
    Other Study ID Numbers:
    • B110_01KT2002
    First Posted:
    Jan 8, 2021
    Last Update Posted:
    Jan 8, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Chong Kun Dang Pharmaceutical
    Kidney Transplantation
    ABO incompatible
    Sirolimus
    Additional relevant MeSH terms:
    Mycophenolic Acid
    Sirolimus

    Study Results

    No Results Posted as of Jan 8, 2021