Study to Compare the Efficacy and Safety After Conversion to RaparoBell® or My-Rept® in Kidney Transplant Patients

NCT05193565 | Active Not Recruiting Phase 4

• 1 other identifier: B110_02KT2103
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and Safety after conversion to RaparoBell® or Myrept® in patients who in renal transplant patients undergoing maintenance therapy with Mycophenolic acid.

Conditions

Kidney Transplantation

Keywords

Kidney Transplantation; Sirolimus

Outcome Measures

Primary Outcomes (1)

• Incidence of composite efficacy failure

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

  Until 24 weeks

Secondary Outcomes (6)

• Incidence of biopsy-confirmed acute rejection(TCMR, AMR)

  Until 24 weeks

• Pathologic Results, Occurrence, Treatment Methods, and Results of Acute Rejection Confirmed by Biopsy

  Until 24 weeks

• Survival rate of transplanted organ

  Until 24 weeks

• Survival rate of Patients

  Until 24 weeks

• Serum-Cr, eGFR

  Until 24 weeks

Study Arms (2)

RaparoBell Tablet

EXPERIMENTAL

RaparoBell Tablet

Drug: Sirolimus

Mycophenolate Mofetil Tablet/Capsule

ACTIVE COMPARATOR

Myrept Tablet/Capsule

Drug: Mycophenolate mofetil

Interventions

Sirolimus DRUG

Orally, once-daily in the morning - Check the blood concentration of Sirolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 3\~8ng/mL

Also known as: RaparoBell® Tab.

RaparoBell Tablet

Mycophenolate mofetil DRUG

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

Also known as: Myrept® Cap./Tab.

Mycophenolate Mofetil Tablet/Capsule

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who at least 1 year and less than 10 years after kidney transplantation
• Over 20 years old
• Patients on immunosuppressive maintenance therapy using combination of Calcineurin Inhibitor and Mycophenolic acid after kidney transplantation

You may not qualify if:

• Patients who have transplanted organs other than kidney
• At the time of Screening
• 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
• Protein/Creatinine ratio≥1.0(mg/mg)
• Patents who had a record of taking mTOR inhibitor before 3 months
• In investigator's judgement

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, South Korea

Seoul, South Korea

Location

MeSH Terms

Interventions

Sirolimus; Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids

Study Officials

• Jae Berm Park, Ph.D

  Samsung Medical Center, Sungkyunkwan University School of Medicine

  STUDY CHAIR

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 3, 2022
• First Posted: January 18, 2022
• Study Start: November 19, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-01

Locations

KR (1)