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

NCT04538651 | Unknown

• 1 other identifier: XC3
• Study Type: observational
• Target: 11,453
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis B, Chronic

Keywords

renal function; chronic hepatitis B; antiviral treatment

Outcome Measures

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.

  within 3 months before study inclusion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chan Xie, PhD

  Third Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chan Xie, PhD

CONTACT

+86 13434383329; happyxiechan@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 30, 2020
• First Posted: September 4, 2020
• Study Start: August 31, 2020
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: September 4, 2020

Record last verified: 2020-09

Locations

CN (1)