Health TrialsbyHealthPanel

Renal Biopsies in Post-liver Transplantation Patients With Renal Impairment

ConditionsLiver TransplantationRenal Insufficiency, Chronic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorRenJi Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

patients received liver transplantation with renal function and received renal biopsy

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • renal biospy

    Behavioral

    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.

Treatment groups

369 Participants
are divided into 1 treatment group
Group A: renal biopsy1 intervention

Trial outcomes

Primary outcomes

1

Progression of renal function

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)

Time frame
96 weeks

Secondary outcomes

1

Risk factors of renal function deterioration in post-liver transplantation with renal impairment after renal biopsy

Investigate the risk factors of renal function deterioration in post-liver transplantation patients with renal impairment after renal biospy. Renal function deterioration is defined as a composite of ESRD or \>100% increase of Scr or \>50% per year decline of eGFR.

Time frame
96 weeks
2

Pathology of kidney disease

Describe the pathology of kidney disease in post-liver transplantation patients with renal impairment.

Time frame
96 weeks
3

Patient survival in post-liver transplantation patients with renal impairment after renal biopsy

Describe the patient survival rate in post-liver transplantation patients with renal impairment after renal biopsy.

Time frame
96 weeks
4

Kidney survival in post-liver transplantation patients with renal impairment after renal biopsy

Describe the kidney survival rate in post-liver transplantation patients with renal impairment.

Time frame
96 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RenJi Hospital

Lead sponsor

Source ClinicalTrials.gov
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