UnknownNot Applicable

Tacrolimus Exposure in Kidney Transplantation

South Korea12,000 participantsStarted 2022-02-01

Plain-language summary

Using CDW data from 5 tertiary hospitals in Korea, this study identify the optimal range of trough level that can prevent adverse outcome in the early periods after transplantation.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Renal transplant recipients between January 1, 2005 through December 31, 2014 in one of the five participating centers * Patients receiving oral tacrolimus as one of the main immunosuppressant at the start of the defined cohort time (i.e. at post-transplant 2 months for the analysis of 1-year outcomes and at post-transplant 12 months for the analysis of 6-year outcomes) Exclusion Criteria: * Graft failure occurring within the first 2 month of transplantation * Mortality of any cause occurring within the first 2 month of transplantation * Patients moving centers during the study period * Patients who have received other organ transplantation(s) besides renal transplantation in the defined period

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

relationship between time varying periodic mean of tacrolimus trough and a composite 1-year allograft outcomes

Timeframe: 1 year after transplantation

Trial details

NCT IDNCT06348446

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-07-30

Contact for this trial

Sangil Min

01071739341 surgeonmsi@gmail.com

View on ClinicalTrials.gov More Kidney Transplant Rejection trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.