Hepatitis B, ChronicNCT04538651
A Cross-sectional Study for Renal Function of Patients With Chronic Hepatitis B in China
An observational study of Hepatitis B, Chronic, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatitis B, Chronic
- How many people
- 11,453 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2020to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510630
Chan Xie, Dr., 8602085252372, happyxiechan@hotmail.com
Chan Xie, PhD
About this study
- 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.
- Conditions
- Hepatitis B, Chronic
- Keywords
- renal function, chronic hepatitis B, antiviral treatment
- Medical subject headings
- Hepatitis B, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 3 months before study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start31 Aug 2020 (estimated)
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 11,453 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chan Xie, Sun Yat-sen University
- Investigators
- Chan Xie, PhD, Principal investigator, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538651
- Sponsor's protocol ID
- XC3
- Status last verified
- Sep 2020
- First submitted
- 30 Aug 2020
- Last updated
- 4 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study for Renal Function of Patients With Chronic Hepatitis B in China
- ClinicalTrials.gov ID
- NCT04538651
- Acronym / sponsor ID
- XC3
- Conditions
- Hepatitis B, Chronic
- Keywords
- renal function, chronic hepatitis B, antiviral treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 11,453 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 31 Aug 2020 (estimated)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 4 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chan Xie, PhD principal investigator
Third Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, Chronic, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chan Xie, PhD (+86 13434383329, happyxiechan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated glomerular filtration rate（eGFR） (time frame: within 3 months before study inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020.