Comparative study of the effect of continuous administration of ETV (entecavir) or switching to TAF (tenofovir araphenamide fumarate) on renal function in cases with HBV infection during ETV administration

Comparative study of the effect of continuous administration of ETV (entecavir) or switching to TAF (tenofovir araphenamide fumarate) on renal function in cases with HBV infection during ETV administration - Renal function of ETV continuation or switching to TAF in ETV administrating hepatitis B patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000034785

Enrollment

Registered

2018-11-06

Start date

2018-11-06

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatits B

Interventions

Continuous administration of ETV 0.5 mg a day p.o. continuously (Cases with prolonged dosing intervals due to renal impairment will continue as is.) Switching to TAF 25 mg a day p.o. continuously

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: HBV-infected patients who received ETV for more than 1 year and satisfy all of the following criteria. 1)eGFR is continuously 60 ml/min/1.73m2 or less. 2) ETV oral compliance is maintained. 3) The antiviral effect is well maintained. (HBV DNA <1.3 log IU/ml)

Exclusion criteria

Exclusion criteria: 1) Patients with CCr (Cockcroft-Gault) less than 15 mL/min. 2) Patients who are concurrently administering with other nucleoside or nucleotide analogue. 3) Patients who the doctor in charge considers inappropriate as the subject in this study.

Design outcomes

Primary

Measure	Time frame
Difference in estimated glomerular filtration rate (eGFR) between the 2 groups from 48 weeks, 96 weeks, and 144 weeks after randomization.	—

Secondary

Measure	Time frame
Difference in changes HBV markers between the 2 groups	—

Countries

Japan

Contacts

Public ContactShuhei Hige

Sapporo-Kosei General Hospital Department of Hepatology

shuhei.hige@ja-hokkaidoukouseiren.or.jp011-261-5331

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026