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Completed

NCT Number: NCT05453448

The Renal Safety of Tenofovir Alafenamide in HBV-related Acute-on-chronic Liver Failure: Real-World Study

Tenofovir alafenamide (TAF) and entecavir (ETV) are the preferred agents in patients with predisposing factors for nephrotoxicity, but few studies to date have directly compared the renal safety of the two antiviral drugs in patients with acute-on-chronic liver failure (ACLF). Hence, the investigators compared the risk of kidney function decline among patients with HBV related acute-on-chronic liver failure (HBV-ACLF) treated with ETV or TAF.From April 2020 to June 2021, a total of 272 HBV-related ACLF hospitalized patients in the Xiangya Hospital of Central South University were enrolled in this prospective study. Chronic hepatitis B was diagnosed by hepatitis B surface antigen and/or hepatitis B virus deoxyribonucleic acid (HBV-DNA) positivity for ≥6 months. ACLF was diagnosed based on the criteria proposed by the APASL Working Party. All patients received antiviral therapy with TAF (25 mg QD, n=100) or ETV (0.5mg QD, n=172), and comprehensive medical treatments. Clinical and laboratory data were collected to evaluate the progression of chronic kidney disease (CKD) .

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Key information

Conditions

Antiviral Drugs

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wenting Peng

Changsha, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • the presence of hepatitis B surface antigen (HBsAg) in the serum for at least 6 months.
  • evidence of active viral replication as documented by measurable HBV DNA in the serum (≥2000IU/mL).

Exclusion criteria

  • Less than 18 years old.
  • history of ESKD or kidney transplantation.
  • unknown baseline estimated glomerular filtration rate (eGFR).
  • coexistence with other liver diseases such as alcoholic liver disease, autoimmune hepatitis, drug-induced liver injury, or other viral infections(hepatitis A, C, and E virus or HIV infection).
  • concomitant with malignant tumor or other serious diseases affecting survival time.
  • patients with missing data. follow-up period of <48 weeks.

Treatment and study plan

Tenofovir alafenamide

Drug

Antiviral therapy

Entecavir

Drug

entecavir

Primary outcomes

  1. the survival rates without transplantation

    Time frame: 48 weeks

    the survival rates without transplantation

Sponsors and collaborators

Lead sponsor

Xiangya Hospital of Central South University

Other

Registry information

Official study title

Higher Risk of Kidney Function Decline With Entecavir Than Tenofovir Alafenamide in Patients With HBV Related Acute-on-chronic Liver Failure: Real-World Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 12, 2022
Registry last updated
Jul 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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