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Could common hepatitis b drugs damage kidneys? a study digs into the data

NCT ID NCT07730905

Knowledge-focused Sponsor: Foshan Hospital of Traditional Chinese Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This study examines whether long-term use of antiviral drugs for chronic hepatitis B is linked to kidney problems in patients who also have non-alcoholic fatty liver disease. Researchers will analyze medical records from 300 patients to compare kidney function among those taking different antivirals and those not on treatment. The goal is to identify high-risk factors that could help guide safer long-term care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
long-term oral nucleoside analog antiviral drugs (tenofovir alafenamide, tenofovir disoproxil fumarate, entecavir)
What this could lead to
If clear risk factors are identified, doctors may be able to monitor kidney function more closely or choose safer antiviral options for patients with fatty liver disease.
What could go wrong
This is a retrospective observational study, so it can show associations but cannot prove cause and effect. The results may not apply to all patient groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

300 people

The number who actually took part.

Started

Sep 2024

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Meet the diagnostic criteria for chronic hepatitis B specified in the 2019 Chinese Society of Infectious Diseases guidelines. 2. Patients received continuous NAS antiviral treatment for at least 12 months. 3. Patients voluntarily participated in the study and signed informed consent. 4. Complete records of liver function, renal function, urinary indicators and HBV-DNA data are available. Exclusion Criteria: 1. Combined with chronic nephritis, nephrotic syndrome and other primary kidney diseases. 2. Co-infection with hepatitis C virus, hepatitis E virus and other hepatitis viruses. 3. Duration of antiviral treatment less than 12 months. 4. Patients with drug resistance during anti-HBV treatment who switched or combined other antiviral agents. 5. Autoimmune hepatitis, alcoholic liver disease, schistosomal liver disease and other liver diseases. 6. Malignant tumor, severe cardiovascular and other systemic serious diseases.

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection hepatitis B virus infection metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-alcoholic fatty liver disease, renal function impairment

Contacts and locations

Locations

  • Foshan Hospital of Traditional Chinese Medicine

    Foshan, Guangdong, 528000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.