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Kidney transplant drug switch under study

NCT ID NCT05193565

Disease control Sponsor: Chong Kun Dang Pharmaceutical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether switching kidney transplant patients from their current maintenance drugs to either RaparoBell® or Myrept® is safe and effective. About 206 adults who had a kidney transplant 1-10 years ago are taking part. The goal is to see if the new drugs prevent rejection and graft loss as well as the standard therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sirolimus (RaparoBell®) and Mycophenolate mofetil (Myrept®)
What this could lead to
If successful, this could show that switching to these drugs is a safe and effective option for long-term kidney transplant maintenance.
What could go wrong
This is a mid-stage trial with 206 participants, so results may not apply to all patients. Risks include rejection, graft loss, or side effects from the new drugs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 206 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2021

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients who at least 1 year and less than 10 years after kidney transplantation 2. Over 20 years old 3. Patients on immunosuppressive maintenance therapy using combination of Calcineurin Inhibitor and Mycophenolic acid after kidney transplantation Exclusion Criteria: 1. Patients who have transplanted organs other than kidney 2. 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 * Protein/Creatinine ratio≥1.0(mg/mg) 3. Patents who had a record of taking mTOR inhibitor before 3 months 4. In investigator's judgement

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Kidney transplantation

Contacts and locations

Locations

  • Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, South Korea

    Seoul, South Korea

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