Immune Monitoring-Guided Individualized Tacrolimus Therapy in Renal Transplant Recipients: An Observational Study and PK/PD Modeling
6. september 2026 opdateret af: Zhongnan Hospital
This study aims to resolve the clinical limitation that therapeutic drug monitoring (TDM) alone cannot accurately reflect the net immune status after kidney transplantation.
Within 12 months post-transplantation, we will systematically characterize dynamic trajectories of biomarkers including TTV DNA load, lymphocyte subsets and cytokines, and quantify their correlations with BK virus infection (over-immunosuppression) and acute rejection (insufficient immunosuppression).
By integrating tacrolimus pharmacokinetics (PK), pharmacogenomics and immune monitoring indicators, a population pharmacokinetic-pharmacodynamic (PopPK/PD) model will be established to provide evidence supporting the paradigm shift from concentration-based dosing to immune effect-guided precision dosing.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Anslået)
50
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
Patients receiving primary allogeneic kidney transplantation
Beskrivelse
Inclusion Criteria:
- Aged 18-65 years, no gender restriction.
- Patients receiving primary allogeneic kidney transplantation.
- Maintenance immunosuppressive regimen based on tacrolimus after transplantation, with complete records of tacrolimus dosage, administration time and therapeutic drug monitoring data available.
- Expected follow-up duration of at least 12 months at this center, and ability to complete scheduled blood and urine sample collection.
- Subjects who fully understand the study protocol with good compliance, and provide written informed consent.
Exclusion Criteria:
- Combined multi-organ transplantation (e.g., combined liver-kidney transplantation).
- ABO-incompatible transplantation or patients with high preformed donor-specific antibody (DSA) titers requiring special induction regimens due to high immunological risk.
- Patients with active HIV, HCV or HBV infection, or preoperative severe active infection requiring systematic anti-infective therapy.
- Patients with delayed graft function or graft loss within 1 week after surgery.
- Patients with severe hepatic or renal dysfunction.
- Participants enrolled in other interventional clinical trials.
- Pregnant or breastfeeding women.
- Other conditions judged inappropriate for study participation by investigators.
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 |
|---|---|
|
Tacrolimus trough blood concentration
Tidsramme: Routine follow-up time points within 12 months after kidney transplantation (1 week, 2 weeks, 1 month, monthly from 2 to 12 months post-operation)
|
Routine follow-up time points within 12 months after kidney transplantation (1 week, 2 weeks, 1 month, monthly from 2 to 12 months post-operation)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Immune monitoring biomarkers (TTV DNA load, lymphocyte subsets, cytokines)
Tidsramme: Collected simultaneously with tacrolimus sampling at all follow-up visits within 12 months post-transplantation
|
Collected simultaneously with tacrolimus sampling at all follow-up visits within 12 months post-transplantation
|
|
BK virus infection, acute cellular rejection
Tidsramme: Recorded and confirmed on the day of event occurrence during 12-month full follow-up
|
Recorded and confirmed on the day of event occurrence during 12-month full follow-up
|
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)
1. september 2026
Primær færdiggørelse (Anslået)
31. december 2027
Studieafslutning (Anslået)
31. december 2028
Datoer for studieregistrering
Først indsendt
6. september 2026
Først indsendt, der opfyldte QC-kriterier
6. september 2026
Først opslået (Faktiske)
11. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2026018k
- 82574502 (Andet bevillings-/finansieringsnummer: National Natural Science Foundation of China)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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