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Not yet recruitingNCT07765615Updated Aug 14, 2026

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

An observational study in Transplant Recipient (Kidney), sponsored by Zhongnan Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by Zhongnan Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Transplant Recipient (Kidney)
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

40

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Target follow-up
1 Week
Patient registry
Yes
05

What researchers measure

Primary outcomes

  1. In vivo exposure of anti-infective agents

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

Secondary outcomes

  1. Conventional renal function markers (Scr, eGFR)

    Time frame: Daily monitoring within 0-5 days post-transplantation

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07765615
Lead sponsor
Zhongnan Hospital
Collaborators
Fudan University
Responsible party
Sponsor
First posted
Aug 14, 2026
Start date
Aug 25, 2026 (estimated)
Primary completion
Jan 31, 2027 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Aug 14, 2026

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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