Liver TransplantationNCT05326399
Renal Biopsies in Post-liver Transplantation Patients With Renal Impairment
An observational study of Liver Transplantation and Renal Insufficiency, Chronic, run by RenJi Hospital at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Transplantation, Renal Insufficiency, Chronic
- What is being tested?
- renal biospy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 369 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jun 2022to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients received liver transplantation with renal function and received renal biopsy
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200127
Shan Mou, Dr, 13918221242, shan_mou@126.com
Haijiao Jin, Dr, 13917735313, jinhaijiao1108@126.com
- Recruiting
Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200127
Haijiao Jin, Dr, +8613917735313, jinhaijiao1108@126.com
Shan Mou
About this study
Official title: Renal Biopsies in Post-liver Transplantation Patients With Renal Impairment: a Single-center, Prospective Cohort Study
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.
Read the 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.
- Being tested
- renal biospy
- Keywords
- Liver transplantation, renal biopsy, chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal biospyBehavioural
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 group | Role | What they receive |
|---|---|---|
| renal biopsy | Standard percutaneous biopsy has been performed in all participants. Light microscope, fluorescence microscope and electron microscope were used for assessment of kidney issue Receives: Behavioral: renal biospy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 96 weeks
Secondary outcomes (6)
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.
Measured: 96 weeks
Pathology of kidney disease
Describe the pathology of kidney disease in post-liver transplantation patients with renal impairment.
Measured: 96 weeks
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.
Measured: 96 weeks
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.
Measured: 96 weeks
Remission of renal disease in post-liver transplantation patients with renal impairment after renal bisopy.
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%)
Measured: 96 weeks
Effect of acute liver failure before liver trasplatation on renal impairment
Investigate the effect of acute liver failure before liver trasplatation on renal impairment with subgroup analysis.
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start1 Jun 2022
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 369 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shan Mou, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326399
- Sponsor's protocol ID
- Renji20220326
- Status last verified
- Nov 2025
- First submitted
- 26 Mar 2022
- Last updated
- 28 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ojo AO, Held PJ, Port FK, Wolfe RA, Leichtman AB, Young EW, Arndorfer J, Christensen L, Merion RM. Chronic renal failure after transplantation of a nonrenal organ. N Engl J Med. 2003 Sep 4;349(10):931-40. doi: 10.1056/NEJMoa021744.
PubMed 12954741Neau-Cransac M, Morel D, Bernard PH, Merville P, Revel P, Potaux L, Saric J. Renal failure after liver transplantation: outcome after calcineurin inhibitor withdrawal. Clin Transplant. 2002 Oct;16(5):368-73. doi: 10.1034/j.1399-0012.2002.02028.x.
PubMed 12225434Welker MW, Weiler N, Bechstein WO, Herrmann E, Betz C, Schoffauer M, Zeuzem S, Sarrazin C, Amann K, Jung O. Key role of renal biopsy in management of progressive chronic kidney disease in liver graft recipients. J Nephrol. 2019 Feb;32(1):129-137. doi: 10.1007/s40620-018-0506-2. Epub 2018 Jun 26.
PubMed 29946864Chan GS, Lam MF, Kwan L, Fung SH, Chan SC, Chan KW. Clinicopathological study of renal biopsies after liver transplantation. Hong Kong Med J. 2013 Feb;19(1):27-32.
PubMed 23378351Lee JH, Cho YH, Ryu SJ, Kim SS, Lee YH, Jang IA, Choi BS, Choi JY, Kim DG, Choi YJ, Yang CW, Chung BH. Clinical usefulness of kidney biopsy in liver transplant recipients with renal impairment. Kidney Res Clin Pract. 2013 Dec;32(4):153-7. doi: 10.1016/j.krcp.2013.08.002. Epub 2013 Oct 24.
PubMed 26877934Kim JY, Akalin E, Dikman S, Gagliardi R, Schiano T, Bromberg J, Murphy B, de Boccardo G. The variable pathology of kidney disease after liver transplantation. Transplantation. 2010 Jan 27;89(2):215-21. doi: 10.1097/TP.0b013e3181c353e5.
PubMed 20098285O'Riordan A, Dutt N, Cairns H, Rela M, O'Grady JG, Heaton N, Hendry BM. Renal biopsy in liver transplant recipients. Nephrol Dial Transplant. 2009 Jul;24(7):2276-82. doi: 10.1093/ndt/gfp112. Epub 2009 Mar 16.
PubMed 19293134Bennett WM. Insights into chronic cyclosporine nephrotoxicity. Int J Clin Pharmacol Ther. 1996 Nov;34(11):515-9.
PubMed 8937936Pillebout E, Nochy D, Hill G, Conti F, Antoine C, Calmus Y, Glotz D. Renal histopathological lesions after orthotopic liver transplantation (OLT). Am J Transplant. 2005 May;5(5):1120-9. doi: 10.1111/j.1600-6143.2005.00852.x.
PubMed 15816895Fujinaga K, Usui M, Yamamoto N, Ishikawa E, Nakatani A, Kishiwada M, Mizuno S, Sakurai H, Tabata M, Isaji S. Hypertension and hepatitis C virus infection are strong risk factors for developing late renal dysfunction after living donor liver transplantation: significance of renal biopsy. Transplant Proc. 2014 Apr;46(3):804-10. doi: 10.1016/j.transproceed.2013.11.103.
PubMed 24767353Pichler RH, Huskey J, Kowalewska J, Moiz A, Perkins J, Davis CL, Leca N. Kidney Biopsies May Help Predict Renal Function After Liver Transplantation. Transplantation. 2016 Oct;100(10):2122-8. doi: 10.1097/TP.0000000000001334.
PubMed 27479161
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Biopsies in Post-liver Transplantation Patients With Renal Impairment: a Single-center, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05326399
- Acronym / sponsor ID
- Renji20220326
- Keywords
- Liver transplantation, renal biopsy, chronic kidney disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 369 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| renal biopsy | – | Behavioral: renal biospyStandard percutaneous biopsy has been performed in all participants. Light microscope, fluorescence microscope and electron microscope were used for assessment of kidney issue |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients received liver transplantation with renal function and received renal biopsy
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| renal biospyStandard 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. | Behavioural | renal biopsy |
Primary outcome
Progression of renal function
Time frame: 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)
6 secondary outcomes
Risk factors of renal function deterioration in post-liver transplantation with renal impairment after renal biopsy
Time frame: 96 weeks
Pathology of kidney disease
Time frame: 96 weeks
Patient survival in post-liver transplantation patients with renal impairment after renal biopsy
Time frame: 96 weeks
Kidney survival in post-liver transplantation patients with renal impairment after renal biopsy
Time frame: 96 weeks
Remission of renal disease in post-liver transplantation patients with renal impairment after renal bisopy.
Time frame: 96 weeks
Effect of acute liver failure before liver trasplatation on renal impairment
Time frame: 96 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Background: PubMed 12954741Ojo AO, Held PJ, Port FK, Wolfe RA, Leichtman AB, Young EW, Arndorfer J, Christensen L, Merion RM. Chronic renal failure after transplantation of a nonrenal organ. N Engl J Med. 2003 Sep 4;349(10):931-40. doi: 10.1056/NEJMoa021744.
- Background: PubMed 12225434Neau-Cransac M, Morel D, Bernard PH, Merville P, Revel P, Potaux L, Saric J. Renal failure after liver transplantation: outcome after calcineurin inhibitor withdrawal. Clin Transplant. 2002 Oct;16(5):368-73. doi: 10.1034/j.1399-0012.2002.02028.x.
- Background: PubMed 29946864Welker MW, Weiler N, Bechstein WO, Herrmann E, Betz C, Schoffauer M, Zeuzem S, Sarrazin C, Amann K, Jung O. Key role of renal biopsy in management of progressive chronic kidney disease in liver graft recipients. J Nephrol. 2019 Feb;32(1):129-137. doi: 10.1007/s40620-018-0506-2. Epub 2018 Jun 26.
- Background: PubMed 23378351Chan GS, Lam MF, Kwan L, Fung SH, Chan SC, Chan KW. Clinicopathological study of renal biopsies after liver transplantation. Hong Kong Med J. 2013 Feb;19(1):27-32.
- Background: PubMed 26877934Lee JH, Cho YH, Ryu SJ, Kim SS, Lee YH, Jang IA, Choi BS, Choi JY, Kim DG, Choi YJ, Yang CW, Chung BH. Clinical usefulness of kidney biopsy in liver transplant recipients with renal impairment. Kidney Res Clin Pract. 2013 Dec;32(4):153-7. doi: 10.1016/j.krcp.2013.08.002. Epub 2013 Oct 24.
- Background: PubMed 20098285Kim JY, Akalin E, Dikman S, Gagliardi R, Schiano T, Bromberg J, Murphy B, de Boccardo G. The variable pathology of kidney disease after liver transplantation. Transplantation. 2010 Jan 27;89(2):215-21. doi: 10.1097/TP.0b013e3181c353e5.
- Background: PubMed 19293134O'Riordan A, Dutt N, Cairns H, Rela M, O'Grady JG, Heaton N, Hendry BM. Renal biopsy in liver transplant recipients. Nephrol Dial Transplant. 2009 Jul;24(7):2276-82. doi: 10.1093/ndt/gfp112. Epub 2009 Mar 16.
- Background: PubMed 8937936Bennett WM. Insights into chronic cyclosporine nephrotoxicity. Int J Clin Pharmacol Ther. 1996 Nov;34(11):515-9.
- Background: PubMed 15816895Pillebout E, Nochy D, Hill G, Conti F, Antoine C, Calmus Y, Glotz D. Renal histopathological lesions after orthotopic liver transplantation (OLT). Am J Transplant. 2005 May;5(5):1120-9. doi: 10.1111/j.1600-6143.2005.00852.x.
- Background: PubMed 24767353Fujinaga K, Usui M, Yamamoto N, Ishikawa E, Nakatani A, Kishiwada M, Mizuno S, Sakurai H, Tabata M, Isaji S. Hypertension and hepatitis C virus infection are strong risk factors for developing late renal dysfunction after living donor liver transplantation: significance of renal biopsy. Transplant Proc. 2014 Apr;46(3):804-10. doi: 10.1016/j.transproceed.2013.11.103.
- Background: PubMed 27479161Pichler RH, Huskey J, Kowalewska J, Moiz A, Perkins J, Davis CL, Leca N. Kidney Biopsies May Help Predict Renal Function After Liver Transplantation. Transplantation. 2016 Oct;100(10):2122-8. doi: 10.1097/TP.0000000000001334.
- Individual participant dataSharing planned: No
Related trials for Liver Transplantation
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingPhase 2
Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
Liver Transplant
RecruitingObservational study
Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation and Renal Insufficiency, Chronic, run by RenJi Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shan Mou, Dr (13918221242, shan_mou@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of renal function (time frame: 96 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05326399, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.