Tenofovir Disoproxil FumarateNCT06896630
Effect of Tenofovir (TDF) on Renal Function in Patients With Chronic Hepatitis B
An observational study of Tenofovir Disoproxil Fumarate and Renal Function Disorder, run by Assiut University at 1 site in Egypt.
Trial summary
Effect of Long-Term Use of Tenofovir (TDF) on Renal Function in Patients with Chronic Hepatitis B Over a Five-Year Period Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tenofovir Disoproxil Fumarate, Renal Function Disorder, Chronic HBV Infection
- What is being tested?
- Tenofovir Disoproxil Fumarate (TDF)
- How many people
- 172 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2025to 1 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
NOUR SHAABAN MOHAMED, RESIDENT OF NEPHROLOGY contact
Egypt1 site
Faculty of Medicine
Asyut
NOUR SHAABAN MOHAMED, RESIDENT, +0201122193390 ext. +0201116123320, NOUR.20124438@MED.AUN.EDU.EG
About this study
Official title: 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
Read the 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.
- Being tested
- Tenofovir Disoproxil Fumarate (TDF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir Disoproxil Fumarate (TDF)Drug
ANTIVIRAL TREATMENT FOR CHRONIC HEPATITIS B VIRUS INFECTION
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in eGFR in Patients on Long-Term Tenofovir (TDF) Therapy
"Renal function will be assessed using estimated glomerular filtration rate (eGFR) calculated by the CKD-EPI equation
Measured: BASELINE
Assessment of Renal Function: Serum Creatinine in Patients on Long-Term Tenofovir (TDF) Therapy
"Renal function will be assessed using serum creatinine levels measured through standard laboratory assays.
Measured: BASELINE
proteinuria will be evaluated through urine protein-to-creatinine ratio
proteinuria will be evaluated through urine protein-to-creatinine ratio (if applicable).
Measured: BASELINE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start10 Apr 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Tenofovir Disoproxil FumarateStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nour shaaban Mohamed Abd elrasoul, Assiut University
- Investigators
- Effat AbdelHady Tony Ahmed, PROFESSOR OF NEPHROLOGY, Study director, Assiut UniversityMohamed Abdelhakim Omran Mahdy, LECTRURER, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896630
- Sponsor's protocol ID
- TDF ON RENAL FUNCTION
- Status last verified
- Apr 2025
- First submitted
- 19 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liang RA, Hoiland II, Ueland T, Aukrust P, Snir O, Hindberg K, Braekkan SK, Garred P, Mollnes TE, Hansen JB. Plasma levels of mannose-binding lectin and future risk of venous thromboembolism. J Thromb Haemost. 2019 Oct;17(10):1661-1669. doi: 10.1111/jth.14539. Epub 2019 Jul 1.
PubMed 31220397Leggio M, Fusco A, D'Emidio S, Severi P, Lombardi M, Caldarone E, Armeni M, Mereu D, Bendini MG, Mazza A. Management of oral anticoagulation in patients with atrial fibrillation: newer agents, newer conundrums? J Intern Med. 2018 Dec;284(6):697-699. doi: 10.1111/joim.12755. Epub 2018 Apr 15. No abstract available.
PubMed 29658167Marques NDSF, Abreu LC, Santos BVD, Neto CFR, Silva JRCD, Braga KKS, Uchoa KDS, Moraes LMS, Ferreira LCP, Ribeiro NG, Santos SLD, Silva TAD, Andrade PE, Raimundo RD. Cardiorespiratory parameters and glycated hemoglobin of patients with type 2 diabetes after a rehabilitation program. Medicine (Baltimore). 2018 Feb;97(8):e9321. doi: 10.1097/MD.0000000000009321.
PubMed 29465549Alontseva DL, Ghassemieh E, Voinarovych S, Russakova A, Kyslytsia O, Polovetskyi Y, Toxanbayeva A. Characterisation of the microplasma spraying of biocompatible coating of titanium. J Microsc. 2020 Sep;279(3):148-157. doi: 10.1111/jmi.12849. Epub 2019 Dec 22.
PubMed 31797374Wang C, Chang D, Wang J, Gao Q, Zhang Y, Niu C, Liu C, Jia Y. Size and crystal symmetry breaking effects on negative thermal expansion in ScF3 nanostructures. Phys Chem Chem Phys. 2021 Nov 10;23(43):24814-24822. doi: 10.1039/d1cp02809j.
PubMed 34714310Tsai HJ, Chuang YW, Yang SS, Chang YZ, Chang HR, Lee TY. Evaluating the renal safety of tenofovir disoproxil fumarate in hepatitis B patients without chronic kidney disease. J Viral Hepat. 2021 Nov;28(11):1579-1586. doi: 10.1111/jvh.13603. Epub 2021 Sep 12.
PubMed 34464999
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Long-Term Use of Tenofovir (TDF) on Renal Function in Patients With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT06896630
- Acronym / sponsor ID
- TDF ON RENAL FUNCTION
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effect of Long-Term Use of Tenofovir (TDF) on Renal Function in Patients with Chronic Hepatitis B Over a Five-Year Period
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Presence of other chronic liver diseases.
- Diagnosed with Chronic Kidney Disease (CKD), regardless of etiology.
- Patients who refuse to participate in the study.
- Interferon and Nucleoside analogue combination therapy.
- Multiple nucleoside analogue combination therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir Disoproxil Fumarate (TDF)ANTIVIRAL TREATMENT FOR CHRONIC HEPATITIS B VIRUS INFECTION | Drug | – |
Primary outcome
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
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.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Background: PubMed 31220397Liang RA, Hoiland II, Ueland T, Aukrust P, Snir O, Hindberg K, Braekkan SK, Garred P, Mollnes TE, Hansen JB. Plasma levels of mannose-binding lectin and future risk of venous thromboembolism. J Thromb Haemost. 2019 Oct;17(10):1661-1669. doi: 10.1111/jth.14539. Epub 2019 Jul 1.
- Background: PubMed 29658167Leggio M, Fusco A, D'Emidio S, Severi P, Lombardi M, Caldarone E, Armeni M, Mereu D, Bendini MG, Mazza A. Management of oral anticoagulation in patients with atrial fibrillation: newer agents, newer conundrums? J Intern Med. 2018 Dec;284(6):697-699. doi: 10.1111/joim.12755. Epub 2018 Apr 15. No abstract available.
- Background: PubMed 29465549Marques NDSF, Abreu LC, Santos BVD, Neto CFR, Silva JRCD, Braga KKS, Uchoa KDS, Moraes LMS, Ferreira LCP, Ribeiro NG, Santos SLD, Silva TAD, Andrade PE, Raimundo RD. Cardiorespiratory parameters and glycated hemoglobin of patients with type 2 diabetes after a rehabilitation program. Medicine (Baltimore). 2018 Feb;97(8):e9321. doi: 10.1097/MD.0000000000009321.
- Background: PubMed 31797374Alontseva DL, Ghassemieh E, Voinarovych S, Russakova A, Kyslytsia O, Polovetskyi Y, Toxanbayeva A. Characterisation of the microplasma spraying of biocompatible coating of titanium. J Microsc. 2020 Sep;279(3):148-157. doi: 10.1111/jmi.12849. Epub 2019 Dec 22.
- Background: PubMed 34714310Wang C, Chang D, Wang J, Gao Q, Zhang Y, Niu C, Liu C, Jia Y. Size and crystal symmetry breaking effects on negative thermal expansion in ScF3 nanostructures. Phys Chem Chem Phys. 2021 Nov 10;23(43):24814-24822. doi: 10.1039/d1cp02809j.
- Background: PubMed 34464999Tsai HJ, Chuang YW, Yang SS, Chang YZ, Chang HR, Lee TY. Evaluating the renal safety of tenofovir disoproxil fumarate in hepatitis B patients without chronic kidney disease. J Viral Hepat. 2021 Nov;28(11):1579-1586. doi: 10.1111/jvh.13603. Epub 2021 Sep 12.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
NOUR SHAABAN MOHAMED, RESIDENT OF NEPHROLOGY contact
Effat AbdelHady Tony Ahmed, PROFESSOR OF NEPHROLOGY study director
Assiut University
Mohamed Abdelhakim Omran Mahdy, LECTRURER study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tenofovir Disoproxil Fumarate and Renal Function Disorder, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact NOUR SHAABAN MOHAMED, RESIDENT OF NEPHROLOGY (01122193390 ext. 01116123320, nour.20124438@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in eGFR in Patients on Long-Term Tenofovir (TDF) Therapy (time frame: BASELINE). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06896630, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.