The BOKITO-2B Study: Tenofovir DF Bone and Kidney Toxicity.;Incidence and reversibility in HBV-monoinfected patients.

The BOKITO-2B Study: Tenofovir DF Bone and Kidney Toxicity.;Incidence and reversibility in HBV-monoinfected patients. - BOKITO-2B

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35281

Enrollment

180

Registered

2011-10-04

Start date

2012-01-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic hepatitis B viral liver infection with hepatitis B virus

Interventions

Dose reduction: Subjects in group 1 meeting the following criteria at inclusion (weeks 0 and 4), will have TDF dose reduction from TDF 300 mg qd to TDF 300 mg eod (Monday-Wednesday-Friday): Patient

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: all adult, cHBV-infected patients on tenofovir or entecavir or without treatment are eligable

Exclusion criteria

Exclusion criteria: HIV-infection

Design outcomes

Secondary

Measure	Time frame
- The values of plasma TFV, urine TFV and intracellular TFV-DP levels in studygroup 1 on normal TDF dose and in those on reduced TDF dose. - The relation between plasma TFV, urine TFV and intracellular TFV-DP levels and the occurrence of KPTD in studygroup 1. - The percentage of patients in studygroup 1, meeting the criteria for dose reduction, maintaining adequate viral suppression.	—

Primary

Measure	Time frame
1. The prevalence and incidence of renal insufficiency and kidney proximal tubular dysfunction (KPTD) in chronic hepatitis B patients on tenofovir, entecavir or without treatment. KPTD is defined as the presence of at least two of the following; a decreased renal threshold phosphate concentration (TmP/GFR 25% decrease in renal clearance since initiation of TDF. 2. Reversibility of renal insufficiency and KPTD following dose reduction at 24 weeks. Reversibility is defined as GFR within 10% of baseline GFR/no agreement with KPTD criteria	—

Measure

Time frame

1. The prevalence and incidence of renal insufficiency and kidney proximal tubular dysfunction (KPTD) in chronic hepatitis B patients on tenofovir, entecavir or without treatment. KPTD is defined as the presence of at least two of the following; a decreased renal threshold phosphate concentration (TmP/GFR 25% decrease in renal clearance since initiation of TDF. 2. Reversibility of renal insufficiency and KPTD following dose reduction at 24 weeks. Reversibility is defined as GFR within 10% of baseline GFR/no agreement with KPTD criteria

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)