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Clinical Trials in China / NCT05326399
Recruiting Observational

Renal Biopsies in Post-liver Transplantation Patients With Renal Impairment

NCT05326399 · tracked via the Priya Life Science China tracker
Sponsor
RenJi Hospital
Phase
Observational
Started
2022-06-01
Last updated
2025-11-28

Condition(s) studied

Liver TransplantationRenal Insufficiency, Chronic

Investigational drug(s) / intervention(s)

renal biospy

renal biospy: Standard percutaneous biopsy has been performed in all participants. Modification of treatment will be jointly decided by hepatologists and nephrologists based on the pathological results. All participants will be followed up for 96 weeks.

Study summary

Investigators will conduct this single-center, prospective cohort study to explore the prevalence and risk factors of renal function progression in post-liver transplantation patients with renal impairment after renal biospy and to understand the the pathology of kidney disease in post-liver transplantation patients with renal impairment.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * age 18-75 years * patients received liver transplantation * new onset of proteinuria(defined as 24-hour proteinuria\>1g/24h, or Urinary albumin creatinine ratio(UACR)\>300mg/g on at least two occasions), and/or renal impairment: eGFR \<60 mL/min/1.73 m² at least two occasions, and/or serum creatinine increase ≥50% from baseline * have received renal biopsy in the past 3 months * Signed informed consent form(ICF) Exclusion Criteria: * patients received renal transplantation * hepatic failure * severe bleeding risk or platelet \<70\*109/L * chronic kidney insufficiency with eGFR\<30ml/min·1.73m2,or kidney atrophy, or solitary kidney, or medullary sponge kidney, or polycystic kidney, or obstructive nephropathy * uncontrolled mental disease or unable to cooperate during operation * Pregnancy or lactation * not suitable for this study judged by investigaters

Primary outcome measure(s)

  • Progression of renal function — 96 weeks
    Describe the cumulative incidence of renal function progression in post-liver transplantation patients with renal impairment after renal biopsy. Renal function progression is defined as a composite of end-starge renal disease(ESRD) or \>100% increase of serum creatinine(Scr) or \>50% per year decline of estimated glomerular filtration rate (eGFR)

Trial sites (2)

FacilityCityRegionStatus
Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine Shanghai China Not Yet Recruiting
Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine Shanghai China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05326399 on ClinicalTrials.gov ↗ ← All trials in China