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

NCT06896630 | Not Yet Recruiting FDA Drug

• 1 other identifier: TDF ON RENAL FUNCTION
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tenofovir Disoproxil Fumarate; Renal Function Disorder; Chronic HBV Infection

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  BASELINE

• proteinuria will be evaluated through urine protein-to-creatinine ratio

  proteinuria will be evaluated through urine protein-to-creatinine ratio (if applicable).

  BASELINE

Interventions

Tenofovir Disoproxil Fumarate (TDF) DRUG

ANTIVIRAL TREATMENT FOR CHRONIC HEPATITIS B VIRUS INFECTION

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine

Asyut, Egypt

Location

Related Publications (6)

• 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.

  PMID: 31220397 BACKGROUND

• Leggio 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.

  PMID: 29658167 BACKGROUND

• Marques 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.

  PMID: 29465549 BACKGROUND

• Alontseva 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.

  PMID: 31797374 BACKGROUND

• Wang 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.

  PMID: 34714310 BACKGROUND

• Tsai 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.

  PMID: 34464999 BACKGROUND

MeSH Terms

Interventions

Tenofovir

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Effat AbdelHady Tony Ahmed, PROFESSOR OF NEPHROLOGY

  Assiut University

  STUDY DIRECTOR

• Mohamed Abdelhakim Omran Mahdy, LECTRURER

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

NOUR SHAABAN MOHAMED, RESIDENT OF NEPHROLOGY

CONTACT

01122193390; nour.20124438@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 26, 2025
• Study Start: April 10, 2025
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

EG (1)