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

Chong Kun Dang

Status and phase: Enrolling; Phase 4

Conditions: Kidney Transplantation

Treatments: Drug: Sirolimus; Drug: Mycophenolate mofetil

Study type: Interventional

Funder types: Industry

Identifiers

NCT05193565

B110_02KT2103

Details and patient eligibility

About

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.

Full 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.

Enrollment: 206 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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206 participants in 2 patient groups

RaparoBell Tablet

Experimental group

Description:

RaparoBell Tablet

Treatment:

Drug: Sirolimus

Mycophenolate Mofetil Tablet/Capsule

Active Comparator group

Description:

Myrept Tablet/Capsule

Treatment:

Drug: Mycophenolate mofetil