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

NCT07765615 | Not Yet Recruiting DMC

• 1 other identifier: 2026195k
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Transplant Recipient (Kidney)

Outcome Measures

Primary Outcomes (1)

• In vivo exposure of anti-infective agents

  Before and after each anti-infective administration within 0-5 days after kidney transplantation

Secondary Outcomes (1)

• Conventional renal function markers (Scr, eGFR)

  Daily monitoring within 0-5 days post-transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

40

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongnan Hospital: lead
• Fudan University: collaborator

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): August 25, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: August 14, 2026

Record last verified: 2026-08