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Can fatty liver and hepatitis b together harm kidneys? a study digs into the data

NCT ID NCT07730736

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks back at the medical records of 1,000 adults with both chronic hepatitis B and metabolic fatty liver disease. The goal is to understand how these conditions affect kidney function, especially in people on long-term antiviral therapy. Researchers will also examine whether different traditional Chinese medicine syndrome types are linked to different levels of liver scarring. No new treatments or tests are given—only existing data is analyzed.

What this could mean

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

What this could lead to
If successful, this study could help identify early signs of kidney damage in patients with chronic hepatitis B and fatty liver disease, potentially guiding safer long-term antiviral treatment.
What could go wrong
This is an observational study that looks back at existing medical records, so it cannot prove cause and effect. The findings may not apply to all patients or lead to changes in treatment.

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

1,000 people

The number who actually took part.

Started

Mar 2025

Finished

May 2026

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 single-center retrospective observational study plans to enroll 1000 eligible subjects from the Hepatology Department of Foshan Hospital of Traditional Chinese Medicine. All participants are aged between 18 and 70 years old, with both male and female patients included. Subjects must meet the diagnostic criteria of chronic hepatitis B combined with metabolic associated fatty liver disease (CHB+MAFLD). Experienced TCM physicians classify all enrolled patients into five syndrome types via four diagnostic methods: spleen damp-heat syndrome, liver depression and spleen deficiency syndrome, spleen deficiency and phlegm-damp syndrome, damp-heat accumulation syndrome, and damp-heat blood stasis syndrome. No drug intervention or additional invasive examinations will be performed. We retrospectively extract routine inpatient and outpatient medical records, including demographic data, liver function indexes, metabolic biomarkers, liver stiffness measurement (LSM), controlled attenuation para

Ages

18 to 70 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. Aged between 18 and 70 years old, male and female patients are both eligible. 2. Meet the diagnostic criteria of chronic hepatitis B (CHB): HBsAg positive for more than 6 months, detectable HBV DNA, accompanied by abnormal liver function, hepatic inflammation or liver fibrosis, and other liver diseases are excluded. 3. Diagnosed with metabolic associated fatty liver disease (MAFLD) confirmed by imaging examination (ultrasound, CT or MRI) with hepatic steatosis ≥5%; patients meet at least one metabolic abnormality standard: BMI ≥25kg/m², fasting glucose ≥5.6mmol/L or type 2 diabetes, hypertension, dyslipidemia; patients without other etiologies of liver injury such as alcoholic liver disease and drug-induced liver injury. 4. Classified into 5 TCM syndrome types by experienced physicians through four diagnostic methods: spleen damp-heat syndrome, liver depression and spleen deficiency syndrome, spleen deficiency and phlegm-damp syndrome, damp-heat accumulation syndrome, damp-heat blood stasis syndrome. 5. Patients fully understand the study content and voluntarily sign the written informed consent form. 6. Complete clinical laboratory, imaging and four-diagnosis record data available for retrospective analysis. Exclusion Criteria: 1. Patients with decompensated cirrhosis (Child-Pugh grade C) or liver failure. 2. Complicated with end-stage renal disease, malignant tumors, severe cardiovascular diseases and other severe systemic diseases. 3. Pregnant or lactating women. 4. Patients with mental disorders who cannot cooperate with data collection and clinical evaluation. 5. Long-term users of immunosuppressants. 6. Patients with incomplete medical records that cannot support complete index analysis. 7. Patients with other confounding liver diseases interfering with the judgment of MAFLD and CHB.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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.