MYREPTIC-N® or MY-REPT® in Stable Patients After Kidney Transplant Recipients

NCT06044493 | Completed Phase 4

• 1 other identifier: B130_01KT2203
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to Evaluate the Efficacy and Safety of MYREPTIC-N® or MY-REPT® in Stable Patients after Kidney Transplant Recipients

Conditions

Kidney Transplant

Keywords

Kidney transplant; Mycophenolic acid

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 (7)

• Change in survey evaluation score [Gastrointestinal symptom rating scale(GSRS), EuroQol-5D(EQ-5D)]

  Changes in scores from the baseline at week 24

• Intra patient variability of mycophenolic acid

  Until 24 weeks

• Intra patient variability of calcineurin inhibitor

  Until 24 weeks

• Incidence of Virus infection

  Until 24 weeks

• Incidence of biopsy-confirmed acute rejection

  Until 24 weeks

Study Arms (2)

Myreptic-N Tablet

EXPERIMENTAL

Mycophenolate sodium

Drug: Myreptic-N Tablet

Myrept Tablet/Capsule

ACTIVE COMPARATOR

Mycophenolate mofetil

Drug: Mycophenolate mofetil Tablet/Capsule

Interventions

Myreptic-N Tablet DRUG

Up to 720mg BID(total 1440mg daily), PO - Check the blood concentration of Mycophenolate at each visit

Also known as: Myreptic-N®

Myreptic-N Tablet

Mycophenolate mofetil Tablet/Capsule DRUG

Up to 1g BID(total 2g daily), PO - Check the blood concentration of Mycophenolate at each visit

Also known as: Myrept® Cap./Tab.

Myrept Tablet/Capsule

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 19 years old
• Patients who at least 1 year after kidney transplant
• serum creatinine ≤2.3 mg/dL
• Patients on immunosuppressive maintenance therapy using combination of Calcineurin Inhibitor and Mycophenolate Mofetil after kidney transplantation

You may not qualify if:

• Patients who had received treatment Acute rejection within 4 weeks
• Patients who had discontinued corticosteroid within 4 weeks
• 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
• In investigator's judgement

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Interventions

Mycophenolic Acid; Capsules

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Jongwon Ha, MD, PhD

  Seoul National University Hospital

  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: August 24, 2023
• First Posted: September 21, 2023
• Study Start: November 14, 2023
• Primary Completion: October 29, 2025
• Study Completion: October 29, 2025
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

KR (1)