Liver Transplantation, Renal Insufficiency, Chronic
Conditions
Keywords
Liver transplantation, renal biopsy, chronic kidney disease
Brief 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.
Detailed description
This is a single-center, prospective, cohort study. This study will include approximate 369 post-liver transplantation patients with renal impairment and have received renal biopsy. Demographic characteristics, medical history, etiology of liver failure, concomitant medications, baseline laboratory parameters, etc., will be recorded. All participants will receive standard treatment by hepatologists and nephrologists based on the pathological results. All participants will be followed up for 96 weeks. Renal function, concomitant medications, and other laboratory parameters, etc., will be obtained.
Interventions
BEHAVIORALrenal 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.
Sponsors
RenJi Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathology of kidney disease | 96 weeks | Describe the pathology of kidney disease in post-liver transplantation patients with renal impairment. |
| Patient survival in post-liver transplantation patients with renal impairment after renal biopsy | 96 weeks | Describe the patient survival rate in post-liver transplantation patients with renal impairment after renal biopsy. |
| Risk factors of renal function deterioration in post-liver transplantation with renal impairment after renal biopsy | 96 weeks | 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. |
| Remission of renal disease in post-liver transplantation patients with renal impairment after renal bisopy. | 96 weeks | To describe the remission rate of renal disease in post-liver transplantation patients with renal impairment after renal biopsy. Remission is defined as 24-hour proteinuria decrease to \<0.3g/24h or \<50%of baseline, with stable kidney function(eGFR decrease less than 15%) |
| Effect of acute liver failure before liver trasplatation on renal impairment | 96 weeks | Investigate the effect of acute liver failure before liver trasplatation on renal impairment with subgroup analysis. |
| Kidney survival in post-liver transplantation patients with renal impairment after renal biopsy | 96 weeks | Describe the kidney survival rate in post-liver transplantation patients with renal impairment. |
Countries
China
Contacts
Primary ContactShan Mou, Dr
Backup ContactHaijiao Jin, Dr
Outcome results
None listed