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New tacrolimus tablet tested in kidney transplant patients

NCT ID NCT04102943

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how a tacrolimus tablet (TacroBell) works in people who received a kidney transplant. The goal was to measure drug levels in the blood and see how well patients tolerated it. 128 adults who were getting a kidney from a deceased or living donor took part. The results help doctors understand if this tablet is a good option for preventing organ rejection.

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

128 people

The number who actually took part.

Started

Nov 2017

Finished

Sep 2020

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

19 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: * Over 19 years old(male or female) * Patients who are planning to receive a kidney from a deceased or a living non-related/related donor * Agreement with written informed consent Exclusion Criteria: * Previously received organs other than kidneys or who are planed to be transplanted simultaneously * Diagnosed with cancer in the last five years \[Patients, however, who have recovered from skin cancer (squamous cell/basal cell carcinoma) or thyroid cancer can be enrolled.\] * Patients or donors who have positive HIV test result * Inadequate for registration under the judgment of the investigator due to severe gastrointestinal disorders * Severe systemic infection requiring treatment * Prior to the kidney transplantation * Treatment with active liver disease or Liver function test(T-bilirubin, Aspartate transaminase(AST), Alanine transaminase(ALT))is over 3 times than upper normal limit * White Blood Cell(WBC) \<2.5 x10\^3/μL, or platelet \<75 x10\^3/μL * Pregnant women or nursing mothers * Fertile women who not practice contraception with appropriate methods * Participated in other trial within 4 weeks * In investigator's judgment

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Conditions

The condition(s) this trial relates to.

end stage renal failure

As listed by the trial registrant

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

Kidney transplant

Contacts and locations

Locations

  • Seoul National University Hospital

    Seoul, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.