A Cross-sectional Study for Renal Function of Patients With Chronic Hepatitis B in China
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|ClinicalTrials.gov Identifier: NCT04538651|
Recruitment Status : Recruiting
First Posted : September 4, 2020
Last Update Posted : September 4, 2020
|Condition or disease|
|Hepatitis B, Chronic|
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.
|Study Type :||Observational|
|Estimated Enrollment :||11453 participants|
|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|
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT04538651
|Contact: Chan Xie, PhD||+86 email@example.com|
|The Third Affiliated Hospital of Sun Yat-Sen University||Recruiting|
|Guangzhou, Guangdong, China, 510630|
|Contact: Chan Xie, Dr. 8602085252372 firstname.lastname@example.org|
|Principal Investigator: Chan Xie, PhD|
|Principal Investigator:||Chan Xie, PhD||Third Affiliated Hospital, Sun Yat-Sen University|