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

C

Chong Kun Dang

Status and phase

Not yet enrolling
Phase 4

Conditions

Kidney Transplant

Treatments

Drug: Myreptic-N Tablet
Drug: Mycophenolate mofetil Tablet/Capsule

Study type

Interventional

Funder types

Industry

Identifiers

NCT06044493
B130_01KT2203

Details and patient eligibility

About

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

Full 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.

Enrollment

158 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

158 participants in 2 patient groups

Myreptic-N Tablet
Experimental group
Description:
Mycophenolate sodium
Treatment:
Drug: Myreptic-N Tablet
Myrept Tablet/Capsule
Active Comparator group
Description:
Mycophenolate mofetil
Treatment:
Drug: Mycophenolate mofetil Tablet/Capsule

Trial contacts and locations

0

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Central trial contact

Jung A Lee; Jogwon Ha, MD, PhD

Data sourced from clinicaltrials.gov

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