CClinicalTrials.gg
Status unknownNCT04538651Updated Sep 4, 2020

A Cross-sectional Study for Renal Function of Patients With Chronic Hepatitis B in China

An observational study in Hepatitis B, Chronic, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-09-04.

Sponsored by Sun Yat-sen University · Observational

The sponsor has not verified this record recently (last verified Sep 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
11,453
Ages
18 Years to 75 Years
Sex
All
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Study summary

  1. To acknowledge the prevalence of renal insufficiency and kidney-related diseases in patients with chronic hepatitis B in China through epidemiological surveys in outpatient clinics of about 150 hospitals across the country; 2. To analyze the related factors of renal insufficiency and kidney-related diseases in domestic patients with chronic hepatitis B from the aspects of demographic characteristics, family history, antiviral treatment, nephrotoxic drug use history, etc.
Read the detailed description

At present, the mainstream antiviral treatment of CHB is still nucleotide analogues. The increase in the proportion of comorbidities in patients with chronic hepatitis B also increases the risk of nucleotide analogue contraindications. The antiviral treatment of CHB patients needs to fully assess the risk of adverse reactions . Taking into account the current impact of nucleotide analogs on renal function, the AASLD 2018 Chronic Hepatitis B Guidelines recommends that the dosage of nucleotide analogs should be adjusted according to renal function and creatinine clearance. A Hong Kong cohort study of patients with chronic hepatitis B showed that the 5-year chronic kidney disease (CKD) progression rate of patients receiving entecavir and tenofovir and not receiving treatment reached 40%. A similar study in the United States also showed that nucleotide analogs reduce the glomerular filtration rate (estimated glomerular filtration rate, eGFR). Studies on the indicators of early kidney injury found that the β2 microglobulin and retinol binding protein indicators changed significantly during the course of patients receiving adefovir dipivoxil, and the baseline β2 microglobulin and retinol binding protein indicators Affect the reduction of eGFR. Retrospective analysis using recent domestic urban medical insurance data also observed that the proportion of chronic kidney disease diagnoses in domestic CHB patients has shown a significant upward trend, which also suggests the necessity of assessing renal function in domestic CHB patients before using nucleotide analogs. Due to the lack of real-world renal function screening studies for CHB patients in China, there is a risk of severe underestimation of the proportion of CHB patients with renal insufficiency estimated based on medical insurance data. In the real world, the proportion of domestic CHB patients with renal insufficiency has not been fully clarified. Domestic clinical The treatment guidelines also did not specifically emphasize the necessity of renal function assessment before receiving nucleotide analog treatment.

Therefore, the purpose of this study is to understand the prevalence of renal insufficiency among people receiving hepatitis B antiviral treatment through a national epidemiological cross-sectional survey, using hospital outpatient clinics as the research site, and to analyze related factors to improve clinicians Awareness of renal insufficiency in patients with CHB and better guidance on the safe use of nucleotide analogs in patients with chronic hepatitis B.

02

Conditions studied

  • Hepatitis B, Chronic

Keywords

  • renal function
  • chronic hepatitis B
  • antiviral treatment
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In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's planned enrollment of 11,453 is above the median of 250 across 687 observational studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

In order to ensure the representativeness of the research subjects, this study will be carried out in the liver disease clinics of about 150 participating hospitals across the country. The source of the hospitals will take into account the region, city size and compliance. After each hospital project is launched, the epidemiological investigation will be completed within 1-3 months according to the sample size allocated by each hospital.

Inclusion criteria

  • Patients with chronic hepatitis B who are older than 18 years old and younger than 75 years old;
  • Currently receiving nucleotide antiviral therapy;
  • Patients are willing to undergo laboratory tests related to renal function: renal function items include glomeruli Filtration rate (eGFR), urea nitrogen (BUN), blood creatinine, uric acid, beta 2 microglobulin, alpha 1 microglobulin and urine protein, etc.;
  • The patient is willing to undergo blood glucose testing;
  • The patients are informed and agree to participate in this session the study.

Exclusion criteria

Exclusion Criteria:

  • Patients with decompensated liver cirrhosis;
  • Patients with HIV infection and malignant tumors;
  • Patients with severe mental illness or unable to cooperate;
  • Female patients during lactation and pregnancy;
  • Participation within three weeks or present Those who are participating in clinical research of other new drugs;
  • Those who cannot understand or express informed consent.
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
11,453 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Estimated glomerular filtration rate(eGFR)

    The amount of ultrafiltrate produced by the kidneys on both sides per unit time (per minute), called glomerular filtration rate, is an important indicator of renal function. Clinically, the glomerular filtration rate estimated in combination with the patient's gender, age, weight, and creatinine value is called the estimated glomerular filtration rate.

    Time frame: within 3 months before study inclusion

07

Study locations

1 of 1 sites recruiting
  • The Third Affiliated Hospital of Sun Yat-Sen University
    Guangzhou, Guangdong 510630, China
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04538651
Lead sponsor
Sun Yat-sen University
Responsible party
Chan Xie (Associate Professor, Sun Yat-sen University) — Principal investigator
First posted
Sep 4, 2020
Start date
Aug 31, 2020 (estimated)
Primary completion
Aug 31, 2021 (estimated)
Completion
Aug 31, 2021 (estimated)
Last update
Sep 4, 2020

Study contacts

Chan Xie, PhD
Contact
happyxiechan@hotmail.com
+86 13434383329
Chan Xie, PhD
principal investigator · Third Affiliated Hospital, Sun Yat-Sen University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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