Analysis of Renal Impairment Characteristics and High-Risk Factors in Chronic Hepatitis B Patients on 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.

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Key information

Conditions

Non-alcoholic Fatty Liver Disease, Renal Function Impairment Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Fatty Liver Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Non-alcoholic Fatty Liver Disease Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Foshan Hospital of Traditional Chinese Medicine

Foshan, Guangdong, 528000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Long-term oral nucleos(t)ide analogs antiviral therapy

Drug

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Foshan Hospital of Traditional Chinese Medicine

Other

Registry information

Official study title

Analysis of Renal Impairment Characteristics and High-Risk Factors in Patients With Chronic Hepatitis B Receiving Long-Term Oral Nucleos(t)Ide Analogues

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jul 28, 2026
Registry last updated: Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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