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

Kidney Transplant Clinical Trial

— MyMy  

Official title:

A Multicenter, Randomization, Open-label Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of MYREPTIC-N® or MY-REPT® in Stable Patients After Kidney Transplant Recipients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06044493
• Other study ID #: B130_01KT2203
• Status: Recruiting
• Phase: Phase 4
• Start date: November 15, 2023
• Est. completion date: November 2025

Study information

• Verified date: September 2023
• Source: Chong Kun Dang Pharmaceutical
• Contact: Jogwon Ha, MD, PhD
• Phone: 82-2-2072-2991
• Email: jwhamd[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: November 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant

Intervention

Drug:
• Myreptic-N Tablet
Up to 720mg BID(total 1440mg daily), PO - Check the blood concentration of Mycophenolate at each visit
• Mycophenolate mofetil Tablet/Capsule
Up to 1g BID(total 2g daily), PO - Check the blood concentration of Mycophenolate at each visit

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of composite efficacy failure	Composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure	Until 24 weeks
Secondary	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.	Changes in scores from the baseline at week 24
Secondary	Intra patient variability of mycophenolic acid	Measurement of blood levels of mycophenolic acid	Until 24 weeks
Secondary	Intra patient variability of calcineurin inhibitor	Measurement of blood levels of calcineurin inhibitor	Until 24 weeks
Secondary	Incidence of Virus infection	Frequency of incidence (BK Virus, CMV)	Until 24 weeks
Secondary	Incidence of biopsy-confirmed acute rejection	Frequency of incidence	Until 24 weeks
Secondary	Incidence of Graft loss	Frequency of incidence	Until 24 weeks
Secondary	Incidence of Death	Frequency of incidence	Until 24 weeks