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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.

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Conditions studied

  • Transplant Recipient (Kidney)
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In context

Lead sponsor

Zhongnan Hospital is the lead sponsor of 106 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Study population

40

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 class C, or /AST > 5 times the accompanied by markedly elevated
  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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

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Study design

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

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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