Study on Precision Dosing Strategies of Anti-infective Agents in the Very Early Stage of Kidney T… (NCT07765615) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study on Precision Dosing Strategies of Anti-infective Agents in the Very Early Stage of Kidney Transplantation
40 participantsStarted 2026-08-25
Plain-language summary
This study addresses the clinical problem that reliance on serum creatinine, eGFR or empirical dosing fails to accurately adjust anti-infective doses given rapid renal function shifts within the very early 0-5 days post kidney transplantation. We will systematically analyze dynamic trajectories of renal biomarkers (serum creatinine, cystatin C, urine output and other renal function indices), quantify their quantitative associations with the exposure, clearance and pharmacodynamic target attainment of anti-infectives. Combined with clinical profiles, medication data, TDM results and perioperative factors, a population PK/PD model will be built for patients in the very early post-transplant stage. We will further validate the value of dynamic renal markers for individualized anti-infective dosing. This research provides evidence for shifting from static renal function-based empirical dosing to precision dosing guided by real-time renal changes and drug exposure, supporting optimized anti-infective dosage, enhanced efficacy and medication safety in early kidney transplant recipients.
Who can participate
Age range
18 Years
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
. Aged \>= 18 years old;
. Patients receiving kidney transplantation within 0-5 days postoperatively;
. Clinically planned administration of anti-infective agents for perioperative prophylaxis, empirical therapy or confirmed infection treatment, with an anticipated treatment duration of no less than 5 days;
. Written informed consent obtained from the subject or legal surrogate;
. Indwelling urinary catheter retained for at least 48 hours postoperatively to facilitate early urine sample collection;
. Patients anticipated to be free of dialysis requirement with urine output or early graft functional recovery at enrollment.
Exclusion criteria
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
1
In vivo exposure of anti-infective agents
Timeframe: Before and after each anti-infective administration within 0-5 days after kidney transplantation
. Previous kidney transplantation or combined multi-organ transplantation
. Patients requiring continuous renal replacement therapy in the early postoperative period
. Severe hepatic dysfunction, defined as Child-Pugh class C, or ALT/AST \> 5 times the upper limit of normal accompanied by markedly elevated bilirubin
. Early postoperative use of ECMO, plasmapheresis or other extracorporeal therapies that substantially alter drug clearance
. Pregnancy or lactation
. Subjects judged inappropriate for enrollment by investigators, including those with unfeasible sampling, extremely short expected survival, severe missing clinical data, etc.