Understanding tacrolimus levels in kidney transplant patients
Tacrolimus Exposure and Outcomes in Kidney Transplant Patients: A Retrospective Multicenter Study of Clinical Data Warehouse (CDW) in South Korea
This study looks at kidney transplant patients to see what levels of the medication tacrolimus can help prevent rejection and improve the chances of a successful transplant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12000 (estimated) |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 4 sites (Seoul and 3 other locations) |
| Trial ID | NCT06348446 on ClinicalTrials.gov |
What this trial studies
This observational study analyzes data from five tertiary hospitals in Korea to determine the optimal trough levels of tacrolimus, an immunosuppressant, that can help prevent adverse outcomes in kidney transplant recipients. By focusing on patients who received renal transplants between 2005 and 2014, the study aims to correlate tacrolimus levels with the incidence of acute rejection and graft survival. The research utilizes electronic health records to track patient outcomes over one and six years post-transplantation.
Who should consider this trial
Good fit: Ideal candidates for this study are renal transplant recipients who received tacrolimus as part of their immunosuppressive regimen within the specified time frame.
Not a fit: Patients who experienced graft failure or mortality within the first two months post-transplantation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of tacrolimus therapy, enhancing graft survival and reducing the risk of rejection in kidney transplant patients.
How similar studies have performed: Other studies have shown success in optimizing immunosuppressant levels in transplant patients, indicating that this approach is both relevant and potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul and 3 other locations
- Asan medical center, Seoul, Korea — Seoul, Korea, Republic of (Recruiting)
- Samsung medical center, Seoul, Korea — Seoul, Korea, Republic of (Recruiting)
- Seoul St. Mary's hospital, Seoul, Korea — Seoul, Korea, Republic of (Recruiting)
- Severance hospital, Seoul, Korea — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Sangil Min
- Email: surgeonmsi@gmail.com
- Phone: 01071739341
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.