Non-alcoholic Fatty Liver Disease, Renal Function ImpairmentNCT07730905
Analysis of Renal Impairment Characteristics and High-Risk Factors in Chronic Hepatitis B Patients on Long-Term Oral Nucleos(t)Ide Analogues
An observational study of Non-alcoholic Fatty Liver Disease, Renal Function Impairment, run by Foshan Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
This is a single-center retrospective observational study. A total of 300 patients with non-alcoholic fatty liver disease treated in our hospital will be included. We collect clinical data, laboratory indicators and imaging results, and analyze the correlation between long-term nucleoside antiviral drugs and renal… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease, Renal Function Impairment
- What is being tested?
- Long-term oral nucleos(t)ide analogs antiviral therapy
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: This is a single-center retrospective cohort study. A total of 300 patients diagnosed with chronic hepatitis B who received continuous NAS antiviral treatment for at least 12 months in Foshan Hospital of Traditional Chinese Medicine will be enrolled, including 150 patients with renal function injury and 150 patients with normal renal function. The age range is 18 to 75 years old, both males and females are included. All patients have complete medical records of liver function, renal function, urinary biomarkers and HBV-DNA results.
Who may be able to join
- Meet the diagnostic criteria for chronic hepatitis B specified in the 2019 Chinese Society of Infectious Diseases guidelines.
- Patients received continuous NAS antiviral treatment for at least 12 months.
- Patients voluntarily participated in the study and signed informed consent.
- Complete records of liver function, renal function, urinary indicators and HBV-DNA data are available.
Who cannot join
- Combined with chronic nephritis, nephrotic syndrome and other primary kidney diseases.
- Co-infection with hepatitis C virus, hepatitis E virus and other hepatitis viruses.
- Duration of antiviral treatment less than 12 months.
- Patients with drug resistance during anti-HBV treatment who switched or combined other antiviral agents.
- Autoimmune hepatitis, alcoholic liver disease, schistosomal liver disease and other liver diseases.
- Malignant tumor, severe cardiovascular and other systemic serious diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
Foshan Hospital of Traditional Chinese Medicine
Foshan, Guangdong, 528000
About this study
Official title: Analysis of Renal Impairment Characteristics and High-Risk Factors in Patients With Chronic Hepatitis B Receiving Long-Term Oral Nucleos(t)Ide Analogues
This is a single-center retrospective observational study. A total of 300 patients with non-alcoholic fatty liver disease treated in our hospital will be included. We collect clinical data, laboratory indicators and imaging results, and analyze the correlation between long-term nucleoside antiviral drugs and renal function changes in patients. The study does not use any new intervention measures, and only conducts statistical analysis on existing medical record data.
- Being tested
- Long-term oral nucleos(t)ide analogs antiviral therapy
- Keywords
- Chronic hepatitis B, antiviral therapy, nucleoside analogs
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-term oral nucleos(t)ide analogs antiviral therapyDrug
Oral nucleos(t)ide analog antiviral drugs, including tenofovir alafenamide, tenofovir disoproxil fumarate, entecavir, used for long-term treatment of chronic hepatitis B virus infection. This is a retrospective observational study analyzing renal safety after long-term antiviral treatment.
| Study group | Role | What they receive |
|---|---|---|
| Long-term antiviral group | Patients with non-alcoholic fatty liver disease who received continuous long-term oral nucleoside antiviral therapy. Receives: Drug: Long-term oral nucleos(t)ide analogs antiviral therapy | |
| Non-long-term antiviral group | Patients with non-alcoholic fatty liver disease without long-term continuous antiviral treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum creatinine level
Serum creatinine levels will be obtained from medical records and compared among patients with chronic hepatitis B in the NA-untreated, entecavir-treated, and tenofovir disoproxil fumarate-treated groups. Serum creatinine will be reported in μmol/L.
Measured: At baseline (the index assessment).
Estimated glomerular filtration rate
Estimated glomerular filtration rate will be determined from serum creatinine using the prespecified equation and compared among patients with chronic hepatitis B in the NA-untreated, entecavir-treated, and tenofovir disoproxil fumarate-treated groups. Values will be reported in mL/min/1.73 m².
Measured: At baseline (the index assessment).
Blood urea nitrogen level
Blood urea nitrogen levels will be obtained from medical records and compared among patients with chronic hepatitis B in the NA-untreated, entecavir-treated, and tenofovir disoproxil fumarate-treated groups. Blood urea nitrogen will be reported in mmol/L.
Measured: At baseline (the index assessment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start4 Sep 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-alcoholic Fatty Liver Disease, Renal Function ImpairmentStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foshan Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lan haiyan, Foshan Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730905
- Sponsor's protocol ID
- FSTCM-KY2024311
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lim J, Choi WM, Shim JH, Lee D, Kim KM, Lim YS, Lee HC, Choi J. Efficacy and safety of tenofovir alafenamide versus tenofovir disoproxil fumarate in treatment-naive chronic hepatitis B. Liver Int. 2022 Jul;42(7):1517-1527. doi: 10.1111/liv.15261. Epub 2022 Apr 3.
PubMed 35343041
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Renal Impairment Characteristics and High-Risk Factors in Patients With Chronic Hepatitis B Receiving Long-Term Oral Nucleos(t)Ide Analogues
- ClinicalTrials.gov ID
- NCT07730905
- Acronym / sponsor ID
- FSTCM-KY2024311
- Keywords
- Chronic hepatitis B, antiviral therapy, nucleoside analogs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Foshan Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 28 Jul 2026 (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.
This is a single-center retrospective observational study. A total of 300 patients with non-alcoholic fatty liver disease treated in our hospital will be included. We collect clinical data, laboratory indicators and imaging results, and analyze the correlation between long-term nucleoside antiviral drugs and renal function changes in patients. The study does not use any new intervention measures, and only conducts statistical analysis on existing medical record data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long-term antiviral group | – | Drug: Long-term oral nucleos(t)ide analogs antiviral therapyPatients with non-alcoholic fatty liver disease who received continuous long-term oral nucleoside antiviral therapy. |
| Non-long-term antiviral group | – | –Patients with non-alcoholic fatty liver disease without long-term continuous antiviral treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a single-center retrospective cohort study. A total of 300 patients diagnosed with chronic hepatitis B who received continuous NAS antiviral treatment for at least 12 months in Foshan Hospital of Traditional Chinese Medicine will be enrolled, including 150 patients with renal function injury and 150 patients with normal renal function. The age range is 18 to 75 years old, both males and females are included. All patients have complete medical records of liver function, renal function, urinary biomarkers and HBV-DNA results.
Key inclusion criteria (4 listed)
- Meet the diagnostic criteria for chronic hepatitis B specified in the 2019 Chinese Society of Infectious Diseases guidelines.
- Patients received continuous NAS antiviral treatment for at least 12 months.
- Patients voluntarily participated in the study and signed informed consent.
- Complete records of liver function, renal function, urinary indicators and HBV-DNA data are available.
Key exclusion criteria (6 listed)
- Combined with chronic nephritis, nephrotic syndrome and other primary kidney diseases.
- Co-infection with hepatitis C virus, hepatitis E virus and other hepatitis viruses.
- Duration of antiviral treatment less than 12 months.
- Patients with drug resistance during anti-HBV treatment who switched or combined other antiviral agents.
- Autoimmune hepatitis, alcoholic liver disease, schistosomal liver disease and other liver diseases.
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 |
|---|---|---|
| Long-term oral nucleos(t)ide analogs antiviral therapyOral nucleos(t)ide analog antiviral drugs, including tenofovir alafenamide, tenofovir disoproxil fumarate, entecavir, used for long-term treatment of chronic hepatitis B virus infection. This is a retrospective observational study analyzing renal safety after long-term antiviral treatment. | Drug | Long-term antiviral group |
Primary outcome
Serum creatinine level
Time frame: At baseline (the index assessment).
Serum creatinine levels will be obtained from medical records and compared among patients with chronic hepatitis B in the NA-untreated, entecavir-treated, and tenofovir disoproxil fumarate-treated groups. Serum creatinine will be reported in μmol/L.
Estimated glomerular filtration rate
Time frame: At baseline (the index assessment).
Estimated glomerular filtration rate will be determined from serum creatinine using the prespecified equation and compared among patients with chronic hepatitis B in the NA-untreated, entecavir-treated, and tenofovir disoproxil fumarate-treated groups. Values will be reported in mL/min/1.73 m².
Blood urea nitrogen level
Time frame: At baseline (the index assessment).
Blood urea nitrogen levels will be obtained from medical records and compared among patients with chronic hepatitis B in the NA-untreated, entecavir-treated, and tenofovir disoproxil fumarate-treated groups. Blood urea nitrogen will be reported in mmol/L.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Background: PubMed 35343041Lim J, Choi WM, Shim JH, Lee D, Kim KM, Lim YS, Lee HC, Choi J. Efficacy and safety of tenofovir alafenamide versus tenofovir disoproxil fumarate in treatment-naive chronic hepatitis B. Liver Int. 2022 Jul;42(7):1517-1527. doi: 10.1111/liv.15261. Epub 2022 Apr 3.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-alcoholic Fatty Liver Disease, Renal Function Impairment, run by Foshan Hospital of Traditional Chinese Medicine at 1 site 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum creatinine level (time frame: At baseline (the index assessment).). The study lists 3 primary outcomes in all. 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 NCT07730905, which also lists 1 linked publication.
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 Jul 2026.