Exploring kidney health in patients after liver transplantation
Renal Biopsies in Post-liver Transplantation Patients With Renal Impairment: a Single-center, Prospective Cohort Study
RenJi Hospital · NCT05326399
This study looks at how kidney health changes over time in people who have had a liver transplant and are experiencing kidney problems, to see what factors might affect their condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 369 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | RenJi Hospital (other) |
| Locations | 2 sites (Shanghai and 1 other locations) |
| Trial ID | NCT05326399 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the prevalence and risk factors associated with the progression of renal function in patients who have undergone liver transplantation and are experiencing renal impairment. Approximately 369 participants will be enrolled, all of whom will have received a renal biopsy within the past three months. The study will collect data on demographic characteristics, medical history, and laboratory parameters, with participants followed for 96 weeks to monitor renal function and treatment outcomes. Standard care will be provided based on the pathological results of the biopsies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 who have received a liver transplant and have new onset proteinuria.
Not a fit: Patients with severe chronic kidney insufficiency or those who have received a renal transplant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of kidney disease in post-liver transplant patients and improve management strategies.
How similar studies have performed: While similar studies have explored renal function in transplant patients, this specific approach focusing on renal biopsies in post-liver transplant patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shanghai and 1 other locations
- 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)
Study contacts
- Study coordinator: Shan Mou, Dr
- Email: shan_mou@126.com
- Phone: 13918221242
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Liver Transplantation, Renal Insufficiency, Chronic, Liver transplantation, renal biopsy, chronic kidney disease