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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04538651
Recruitment Status : Recruiting
First Posted : September 4, 2020
Last Update Posted : September 4, 2020
Information provided by (Responsible Party):
Chan Xie, Sun Yat-sen University

Brief 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.

Condition or disease
Hepatitis B, Chronic

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.

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Study Type : Observational
Estimated Enrollment : 11453 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Cross-sectional Study for Renal Function of Patients With Chronic Hepatitis B in China
Estimated Study Start Date : August 31, 2020
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Primary Outcome Measures :
  1. Estimated glomerular filtration rate(eGFR) [ Time Frame: within 3 months before study inclusion ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04538651

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Contact: Chan Xie, PhD +86 13434383329

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China, Guangdong
The Third Affiliated Hospital of Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Chan Xie, Dr.    8602085252372   
Principal Investigator: Chan Xie, PhD         
Sponsors and Collaborators
Sun Yat-sen University
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Principal Investigator: Chan Xie, PhD Third Affiliated Hospital, Sun Yat-Sen University
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Responsible Party: Chan Xie, Associate Professor, Sun Yat-sen University Identifier: NCT04538651    
Other Study ID Numbers: XC3
First Posted: September 4, 2020    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chan Xie, Sun Yat-sen University:
renal function
chronic hepatitis B
antiviral treatment
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections