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

Phase 4RecruitingNCT06044493

Chong Kun Dang Pharmaceutical158 enrolled

Overview

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

This study is a multi-center, Randomized, Open-label and phase IV clinical trial that evaluates the efficacy and safety of MYREPTIC-N® or MY-REPT® administration for 24 weeks in renal transplant patients combined Calcineurin inhibitor.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

158

Conditions

Kidney Transplant

Interventions

Myreptic-N TabletDRUG

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

Mycophenolate mofetil Tablet/CapsuleDRUG

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

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Over 19 years old 2. Patients who at least 1 year after kidney transplant 3. serum creatinine ≤2.3 mg/dL 4. Patients on immunosuppressive maintenance therapy using combination of Calcineurin Inhibitor and Mycophenolate Mofetil after kidney transplantation Exclusion Criteria: 1. Patients who had received treatment Acute rejection within 4 weeks 2. Patients who had discontinued corticosteroid within 4 weeks 3. 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 4. In investigator's judgement

Locations (1)

Seoul National University Hospital

Seoul, Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Incidence of composite efficacy failure

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

Time frame: Until 24 weeks

Secondary Outcomes

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

The GSRS consists of 15 questions, with a total score of 15 to 105, indicating that the higher the total score, the more severe the gastrointestinal symptoms. The EQ-5D evaluates quality of life and consists of 5 questions. Each question is evaluated in the range of 1 to 5. The score is calculated according to EQ-5D index. Calculated score is lower that means poor health.

Time frame: Changes in scores from the baseline at week 24

Intra patient variability of mycophenolic acid

Measurement of blood levels of mycophenolic acid

Time frame: Until 24 weeks

Intra patient variability of calcineurin inhibitor

Measurement of blood levels of calcineurin inhibitor

Time frame: Until 24 weeks

Incidence of Virus infection

Frequency of incidence (BK Virus, CMV)

Time frame: Until 24 weeks

Incidence of biopsy-confirmed acute rejection

Frequency of incidence

Time frame: Until 24 weeks

Incidence of Graft loss

Frequency of incidence

Time frame: Until 24 weeks

Central Contacts

Jogwon Ha, MD, PhD

CONTACT

82-2-2072-2991 jwhamd@snu.ac.kr

Jung A Lee

CONTACT

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

Data from ClinicalTrials.gov

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