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

Phase 4

• Conditions: Kidney Transplantation
• Interventions: Drug: Mycophenolate mofetil; Drug: Sirolimus

• Registration Number: NCT05193565
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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.

Detailed Description

This study is a multi-center, Randomized, Open-label and phase IV clinical trial that evaluates the efficacy and safety after conversion to RaparoBell® or Myrept® administration for 24 weeks in renal transplant patients undergoing maintenance therapy with Mycophenolic acid.

Study Timeline

• Study Start: 2021-11-19
• Status Verified: 2021-12
• Study First Submitted: 2022-01-03
• Study First Submitted QC: 2022-01-03
• Last Update Submitted: 2022-01-16
• Study First Posted: 2022-01-18
• Last Update Posted: 2022-02-01
• Primary Completion: 2024-01
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

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

Exclusion Criteria

1. Patients who have transplanted organs other than kidney

2. 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)

3. Patents who had a record of taking mTOR inhibitor before 3 months

4. In investigator's judgement

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mycophenolate Mofetil Tablet/Capsule	Mycophenolate mofetil	Myrept Tablet/Capsule
RaparoBell Tablet	Sirolimus	RaparoBell Tablet

Primary Outcome Measures

Name	Time	Method
Incidence of composite efficacy failure	Until 24 weeks	Composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure

Secondary Outcome Measures

Name	Time	Method
Survival rate of Patients	Until 24 weeks	Kaplan-Meier
Incidence of BKV, CMV infection	Until 24 weeks	The frequency and Incidence
Pathologic Results, Occurrence, Treatment Methods, and Results of Acute Rejection Confirmed by Biopsy	Until 24 weeks	By Banff classification categories
Incidence of biopsy-confirmed acute rejection(TCMR, AMR)	Until 24 weeks	The frequency and Incidence
Survival rate of transplanted organ	Until 24 weeks	Kaplan-Meier
Serum-Cr, eGFR	Until 24 weeks	eGFR using MDRD

Trial Locations

Locations (1)

The Catholic University of Korea, Seoul, St.Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of