TDF Dose Adjustment VS. Switching to TAF in TDF-experienced CHB Patients With Renal Impairment

NCT04391608 | Unknown Phase 4 DMC

• 1 other identifier: Si 798/2019
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Tenofovir is a nucleotide analog drug that works against both Human immunodeficiency virus (HIV) and HBV. TDF and TAF are prodrug of Tenofovir. TAF has a higher plasma stability than TDF, which makes TDF require a higher dose to get the concentration of drugs in the liver equal to the amount of TAF. Previous studies have shown the effects of TAF once daily and TDF once daily on kidney function and bone mass. The efficacy of TAF in virus suppression is comparable to TDF, but the effect on the kidneys and bone mass from TAF has less side effects than TDF. In addition, changing the medication from TDF to TAF shows that kidney function tends to improve. Hepatitis B patients taking TDF have adjusted their dosage due to impair renal function, for example, from 1 time per day to every 48 hours or every 72 hours. This group of patients does not have a clear evidence-based recommendation for choosing a reduced dose of TDF or change to TAF. Therefore, the main objective of this study is to study patients with hepatitis B who have taken TDF and have renal function impairment that have been adjusted. Taking the same medicine with dose adjustment or changing the drug to TAF which treatment will more improve the kidney function.

Conditions

Renal Insufficiency; Tenofovir

Keywords

Tenofovir; Tenofovir disoproxil fumarate; Tenofovir alafenamide; TDF; TAF; Renal; Impairment; Insufficiency

Outcome Measures

Primary Outcomes (1)

• Renal safety assessed by changes in eGFR

  To study renal function changes by measuring eGFR during Tenofovir disoproxil fumarate (TDF) dose reduction versus switching to Tenofovir alafenamide (TAF) after 48 weeks of treatment in chronic hepatitis B with impaired kidney function

  48 weeks

Secondary Outcomes (6)

• Renal safety assessed by changes in urine sugar (0 to 4+)

  48 weeks

• Renal safety assessed by changes in urine protein creatinine ratio

  48 weeks

• Renal safety assessed by changes in urine ß2-microglobulin (µg/mL)

  48 weeks

• Renal safety assessed by changes in urine phosphate (mg/dL)

  48 weeks

• Renal safety assessed by changes in urine neutrophil gelatinase-associated lipocalin (NGAL) (ng/mL)

  48 weeks

Study Arms (2)

Tenofovir Alafenamide

ACTIVE COMPARATOR

Tenofovir Alafenamide 25 mg/day

Drug: Switching to Tenofovir Alafenamide

TDF dose reduction

NO INTERVENTION

TDF dose reduction

Interventions

Switching to Tenofovir Alafenamide DRUG

Switching from Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide

Also known as: Switching from Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide

Tenofovir Alafenamide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 - 75 years old
• Chronic hepatitis B virus infection
• Reduced renal function and need to adjust the dose of TDF
• Have an eGFR of \> 15 ml / min.
• HBV DNA viral load levels \< 10 U/mL in the last 3 months before participating in the project
• No HCC by Ultrasonography of the upper abdomen or CT 3-phase of liver or MRI liver in the 3 months before participating in the project.

You may not qualify if:

• HIV infection or hepatitis C or hepatitis D co-infection
• Decompensated cirrhosis, including variceal bleeding, ascites, hepatic encephalopathy
• Active hepatocellular carcinoma or during the 3 years after treatment
• Solid organ transplantation or Bone marrow transplantation
• Chronic kidney disease caused by glomerulonephritis, tubulo-interstitial nephritis), Obstructive uropathy or autosomal dominant polycystic kidney, and Kidney disease from other causes
• Diabetes with HbA1c\> 8 or uncontrollable hypertension
• Active malignancy of cancer in other organs in the last 3 years
• History of receiving non-steroidal anti-inflammatory drugs (NSAIDs) or other nephrotoxic drugs within the past 1 month (except tenofovir) (For patients receiving NSAIDS after participating in this study, patients were advised to stop taking NSAIDs but not exclude from the study)
• Receive immunosuppressive drug
• Pregnancy

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Watcharasak Chotiyaputta, Asso Prof

  Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Watcharasak Chotiyaputta, Asso Prof

CONTACT

ุุุ6624197281; watcharasak.cho@mahidol.ac.th

Tawesak Tanwandee, Asso Prof

CONTACT

6624197282; tawesak@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Faculty of Medicine, Siriraj Hospital

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 18, 2020
• Study Start: November 9, 2019
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: March 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)