NCT04700709

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
158

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2021

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

January 8, 2021

Status Verified

January 1, 2021

Enrollment Period

3.9 years

First QC Date

January 6, 2021

Last Update Submit

January 6, 2021

Conditions

Kidney Transplantation

Keywords

Kidney TransplantationABO incompatibleSirolimus

Outcome Measures

Primary Outcomes (1)

  • Incidence of composite efficacy failure

    Composite efficacy failure include biopsy-confired acute rejection, graft loss, death, or follow-up failure

    Until 48 weeks after taking medicine

Secondary Outcomes (6)

  • Incidence of composite efficacy failure

    Until 24 weeks after taking medicine

  • Incidence of biopsy-confirmed acute rejection

    Until 24weeks and 48weeks after taking medicine

  • 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

  • Survival rate

    Until 24weeks and 48weeks after taking medicine

  • Function of Kidney

    Until 24weeks and 48weeks after taking medicine

  • +1 more secondary outcomes

Study Arms (2)

RaparoBell® Tablet

EXPERIMENTAL

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

Drug: Sirolimus Tab.

Mycophenolate Mofetil Tablet/Capsule

ACTIVE COMPARATOR

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

Drug: Mycophenolate Mofetil Cap./Tab.

Interventions

Sirolimus Tab.DRUG

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.

Also known as: RaparoBell® Tab.
RaparoBell® Tablet
Mycophenolate Mofetil Cap./Tab.DRUG

Up to 1g BID(total 2g daily), PO

Also known as: Myrept® Cap./Tab.
Mycophenolate Mofetil Tablet/Capsule

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \[Time of Screening\]
  • 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

You may not qualify if:

  • \[Time of Screening\]
  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Sirolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Kyu Ha Huh, M.D, Ph.D

    Severance Hospital

    STUDY CHAIR

Central Study Contacts

Kyu Ha Huh, M.D, Ph.D

CONTACT

+82-2-2228-2138KHHUH@yuhs.ac

Jung A Lee

CONTACT

+82-2-2194-0403junaa82@ckdpharm.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2021

First Posted

January 8, 2021

Study Start

January 1, 2021

Primary Completion

December 1, 2024

Study Completion

January 1, 2025

Last Updated

January 8, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)