The BOKITO-1B study: tenofovir DF bone and kidney toxicity. Pharmacology in HBV-monoinfected patients.

Phase 4

• Conditions: 10019654; 10047438; chronic hepatitis B; viral liver infection with hepatitis B virus

• Registration Number: NL-OMON35480
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

chronic hepatitis B virus infection.
adult age: at least 18 years of age.
meeting the criteria for antiviral treatment.

Exclusion Criteria

creatinine clearance at initiation < 50 mL/min.
HIV- or HCV-coinfected.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The occurrence of kidney proximal tubular dysfunction (KPTD) in patients with<br /><br>or without mildly decreased GFR.<br /><br><br /><br>KPTD is defined as the presence of at least two of the following; a<br /><br>decreased renal threshold phosphate concentration (TmP/GFR < 0.80<br /><br>mmol/L), any normoglycemic (<10 mmol/L) glycosuria, hyperaminoaciduria,<br /><br>hyper &beta;2-microglobulinuria (normal < 400 µg/L), increased<br /><br>retinol binding protein loss (normal < 0.017 mg RBP/mmol creatinine),<br /><br>hyperuricosuria (normal < 5 mmol/24h).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The values of plasma TFV, urine TFV and intracellular TFV-DP levels in both<br /><br>studygroups.<br /><br>- The relation between plasma TFV, urine TFV and intracellular TFV-DP levels<br /><br>and the occurrence of KPTD.<br /><br>- The difference in bone mineralisation in the first year of treatment within<br /><br>and between studygroups.</p><br>