Study on Precision Dosing Strategies of Anti-infective Agents in the Very Early Stage of Kidney Transplantation

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07765615

Enrollment

Registered

2026-08-14

Start date

2026-08-25

Completion date

2027-08-31

Last updated

2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transplant Recipient (Kidney)

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Aged \>= 18 years old; 2. Patients receiving kidney transplantation within 0-5 days postoperatively; 3. 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; 4. Written informed consent obtained from the subject or legal surrogate; 5. Indwelling urinary catheter retained for at least 48 hours postoperatively to facilitate early urine sample collection; 6. Patients anticipated to be free of dialysis requirement with urine output or early graft functional recovery at enrollment.

Exclusion criteria

1. Previous kidney transplantation or combined multi-organ transplantation 2. Patients requiring continuous renal replacement therapy in the early postoperative period 3. Severe hepatic dysfunction, defined as Child-Pugh class C, or ALT/AST \> 5 times the upper limit of normal accompanied by markedly elevated bilirubin 4. Early postoperative use of ECMO, plasmapheresis or other extracorporeal therapies that substantially alter drug clearance 5. Pregnancy or lactation 6. Subjects judged inappropriate for enrollment by investigators, including those with unfeasible sampling, extremely short expected survival, severe missing clinical data, etc.

Design outcomes

Primary

Measure	Time frame
In vivo exposure of anti-infective agents	Before and after each anti-infective administration within 0-5 days after kidney transplantation

Secondary

Measure	Time frame
Conventional renal function markers (Scr, eGFR)	Daily monitoring within 0-5 days post-transplantation

Outcome results