MedTrace Logo

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

NCT05453448 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2022-07-12

No results posted yet for this study

Summary

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) .

Conditions

  • Antiviral Drugs

Interventions

DRUG

tenofovir alafenamide

Antiviral therapy

DRUG

Entecavir

entecavir

Sponsors & Collaborators

  • Xiangya Hospital of Central South University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2022-05-30
Completion
2022-05-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05453448 on ClinicalTrials.gov