Effect of Tenofovir (TDF) on Renal Function in Patients With Chronic Hepatitis B

April 2, 2025 updated by: Nour shaaban Mohamed Abd elrasoul, Assiut University

Effect of Long-Term Use of Tenofovir (TDF) on Renal Function in Patients With Chronic Hepatitis B

Effect of Long-Term Use of Tenofovir (TDF) on Renal Function in Patients with Chronic Hepatitis B Over a Five-Year Period

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Hepatitis B is a viral infection that affects 257 million people worldwide and approximately 820,000 die annually of HBV-related causes and is a leading cause of liver cirrhosis and hepato-cellular carcinoma . Thus, it is a global public health problem. The diagnosis of chronic hepatitis B (CHB) infection is based on the persistence of hepatitis B surface antigens (HBsAg) for more than six months . Some patients may experience acute exacerbation of the HBV infection and progression to acute-on chronic liver failure (ACLF), which has a high mortality rate in spite of substantial supporting and the use of a great quantity resources. Liver transplantation is a latent treatment election for most ACLF patients; hence, factors such as donor shortage and high cost restrict its clinical application.

Hence, Early intervention and treatment are very important in patients with ACLF.

The goals of antiviral therapy are to suppress viral replication and to ensure the loss of related antigens . Currently, there are two classes of antiviral drugs that are approved for the treatment of chronic Hepatitis B infection: Interferon alpha and Nucleoside analogues. Among the Nucleoside analogues, Entecavir (ETV), Tenofovir disoproxil fumarate (TDF), and Tenofovir alafenamide fumarate (TAF), are the most widely used as first-line treatments. The effectiveness of Nucleos(t)ide analogues (NUCs) is evident, and their usage is easier as they are administered orally and have fewer side effects. But most patients require long-term treatment as premature discontinuation of NUCs treatment may result in virological relapse and liver failure. TDF is one of the most potent antiviral agents against HBV and HIV. However, its potential effects on renal insufficiency are still being questioned . Tenofovir, Entecavir, and Telbivudine are more widely used due to their superior virological, biochemical, and clinical efficacy. They also have a higher barrier to resistance and more tolerable side effect profiles .The kidney is the primary route for the excretion of NUCs so that nephrotoxicity can be encountered during usage of these agents. Although the exact mechanism of nephrotoxicity is not well known, it can be attributed to alterations in renal tubular transporters especially in the proximal renal tubules, as well as apoptosis and mitochondrial toxicity. The tubular damage leads to defective proximal tubular secretion and reabsorption of several substances including phosphate, resulting in reduced serum phosphate levels, elevated phosphate levels in the urine and elevated serum levels of creatinine.

Tenofovir disoproxil fumarate (TDF), the prodrug of the Nucleotide analogue reverse transcriptase inhibitor (NRTI) Tenofovir, is active against both HIV and HBV. TDF use as part of antiretroviral therapy (ART) carries a risk of proximal tubular dysfunction and declining glomerular filtration rate (GFR), and monitoring of renal function is recommended during treatment . The risk is related to both level and length of TDF exposure and is enhanced by co-administration of pharmacological boosters (e.g., Ritonavir), low body weight, and pre-existing chronic kidney disease (CKD).

Whilst TDF discontinuation is generally associated with improved renal function, longer exposure and lower GFR at TDF interruption predict a reduced likelihood of GFR recovery.

Study Type

Observational

Enrollment (Estimated)

172

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Study Population Age Range: 18 to 60 years Sex: Male and Female HBV Status: HBV-positive patients Treatment Duration: Long-term use of Tenofovir (TDF) for more than five years Sampling Method: Non-Probability Sampling Healthy Volunteers: Not Accepted

Description

Inclusion Criteria:

Adult male or female patients aged 18 to 60 years.

Diagnosed as HBV-positive.

Long-term use of Tenofovir Disoproxil Fumarate (TDF) for more than five years.

Exclusion Criteria:

Presence of other chronic liver diseases.

Diagnosed with Chronic Kidney Disease (CKD), regardless of etiology.

Patients who refuse to participate in the study.

Patients on combination therapy, including:

Interferon and Nucleoside analogue combination therapy.

Multiple nucleoside analogue combination therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in eGFR in Patients on Long-Term Tenofovir (TDF) Therapy
Time Frame: BASELINE
"Renal function will be assessed using estimated glomerular filtration rate (eGFR) calculated by the CKD-EPI equation
BASELINE
Assessment of Renal Function: Serum Creatinine in Patients on Long-Term Tenofovir (TDF) Therapy
Time Frame: BASELINE
"Renal function will be assessed using serum creatinine levels measured through standard laboratory assays.
BASELINE
proteinuria will be evaluated through urine protein-to-creatinine ratio
Time Frame: BASELINE
proteinuria will be evaluated through urine protein-to-creatinine ratio (if applicable).
BASELINE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Effat AbdelHady Tony Ahmed, PROFESSOR OF NEPHROLOGY, Assiut University
  • Study Director: Mohamed Abdelhakim Omran Mahdy, LECTRURER, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 10, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

March 19, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

March 26, 2025

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

April 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDF ON RENAL FUNCTION

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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