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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35480

Enrollment

Registered

2011-10-04

Start date

2012-01-01

Completion date

Unknown

Last updated

2024-04-29

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

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: creatinine clearance at initiation

Design outcomes

Primary

Measure	Time frame
The occurrence of kidney proximal tubular dysfunction (KPTD) in patients with or without mildly decreased GFR. KPTD is defined as the presence of at least two of the following; a decreased renal threshold phosphate concentration (TmP/GFR	—

Secondary

Measure	Time frame
- The values of plasma TFV, urine TFV and intracellular TFV-DP levels in both studygroups. - The relation between plasma TFV, urine TFV and intracellular TFV-DP levels and the occurrence of KPTD. - The difference in bone mineralisation in the first year of treatment within and between studygroups.	—

Countries

Netherlands

Outcome results