Evaluating MYREPTIC-N® or MY-REPT® in Kidney Transplant Patients
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
This study is testing if the medications MYREPTIC-N® or MY-REPT® can help stable kidney transplant patients keep their kidneys healthy while they continue their usual treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 158 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Chong Kun Dang Pharmaceutical Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06044493 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a multi-center, randomized, open-label phase IV study aimed at assessing the efficacy and safety of MYREPTIC-N® or MY-REPT® in stable kidney transplant patients. Participants will receive treatment for 24 weeks while on a regimen that includes a calcineurin inhibitor. The study focuses on patients who are at least one year post-transplant and are currently on immunosuppressive therapy. The goal is to determine how well these medications work in maintaining kidney function and overall patient health.
Who should consider this trial
Good fit: Ideal candidates are adults over 19 years old who are at least one year post-kidney transplant and currently on a specific immunosuppressive regimen.
Not a fit: Patients who have experienced acute rejection recently or have significant liver dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of kidney transplant patients by optimizing immunosuppressive therapy.
How similar studies have performed: Other studies have shown promising results with similar immunosuppressive therapies, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Jogwon Ha, MD, PhD
- Email: jwhamd@snu.ac.kr
- Phone: 82-2-2072-2991
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.