- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07765615
Study on Precision Dosing Strategies of Anti-infective Agents in the Very Early Stage of Kidney Transplantation
11. august 2026 opdateret af: Zhongnan Hospital
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Anslået)
40
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
40
Beskrivelse
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:
- 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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
In vivo exposure of anti-infective agents
Tidsramme: Before and after each anti-infective administration within 0-5 days after kidney transplantation
|
Before and after each anti-infective administration within 0-5 days after kidney transplantation
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Conventional renal function markers (Scr, eGFR)
Tidsramme: Daily monitoring within 0-5 days post-transplantation
|
Daily monitoring within 0-5 days post-transplantation
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
25. august 2026
Primær færdiggørelse (Anslået)
31. januar 2027
Studieafslutning (Anslået)
31. august 2027
Datoer for studieregistrering
Først indsendt
11. august 2026
Først indsendt, der opfyldte QC-kriterier
11. august 2026
Først opslået (Faktiske)
14. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2026195k
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
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