To Evaluate the Efficacy and Safety of Tenofovir Alafenamide Conversion in Liver Transplant Patients
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorJongman Kim
About this trial
This clinical trial aims to confirm the efficacy and safety of Vemlia® tablets (Tenofovir alafenamide) in liver transplant patients with hepatitis B, focusing on their effects on renal function.
HBV reactivation post-liver transplantation can result in a post-transplant mortality rate of up to 50% within two years, making prophylaxis critical. Currently, a combination therapy of HBIG and nucleotide analogues is commonly used. Among the nucleotide analogues (NA), entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are frequently used as first-line therapies. However, both ETV and TDF have nephrotoxicity, requiring caution in patients with chronic kidney disease. Specifically, 18% of liver transplant patients develop chronic kidney disease due to immunosuppressant use, making the appropriate use of antiviral drugs to preserve renal function crucial.
TAF has been reported through RCTs to be more effective than TDF in preserving renal function and bone density, while showing similar antiviral effects. However, these studies have been conducted exclusively on general chronic liver disease patients. Although multicenter studies have been reported for liver transplant patients, they were retrospective and involved a limited number of patients.
Therefore, the primary objective of this study is to assess the impact of converting to TAF on renal function preservation in liver transplant patients taking antivirals for HBV prophylaxis. The secondary objectives are to evaluate the antiviral effect on HBV, the impact on lipid profiles, and the effectiveness in preserving bone density.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 19 years or older.
Patients taking antiviral therapy other than TAF for HBV prophylaxis.
Patients with a tacrolimus trough level maintained between 3-10 ng/mL.
Patients who have voluntarily decided to participate in the clinical trial after fully understanding the detailed explanation of the trial and have provided written consent.
Disqualifiers
Patients who have undergone transplantation of organs other than the liver or re-transplantation.
Patients who have received BAL system treatment or auxiliary partial orthotopic liver transplantation (APOLT) before the transplantation.
Patients with concurrent viral infections (HCV, HIV).
Patients taking mTOR inhibitors (e.g., Everolimus (Certican), etc.).
Trial design
Design model
Single group
Treatments tested in this trial
Tenofovir Alafenamide Citrate
DrugTenofovir alafenamide is administered once every day with 25mg PO for 48 weeks.
Treatment groups
108 Participants
are divided into 1 treatment groupGroup A: Experimental(Tenofovir alafenamide)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The amount of eGFR change
The amount of eGFR change at 12months after conversion compared to before TAF conversion
Time frame
Through study completion, an average of 12monthsSecondary outcomes
1
The amount of Creatinine change
Creatinine status by 12 months after conversion compared to before TAF conversion
Time frame
an average of 12months2
The amount of CKD stage change
CKD stage status by 12 months after conversion compared to before TAF conversion
Time frame
an average of 12months3
effectiveness
HBV recurrence rate
Time frame
Through study completion, an average of 12months4
BMD change
BMD status by 12 months after conversion compared to before TAF conversion
Time frame
an average of 12monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jongman Kim
Lead sponsor
Samsung Medical Center
Sponsor institution
Source ClinicalTrials.gov
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