Chronic hepatitis B
Conditions
Interventions
Trade Name: Viread
Product Name: Viread
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TENOFOVIR disoproxil
CAS Number: 147127-20-6
Current Sponsor code: TDF1
Concentration unit: mg mil
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria Adult (> 18 years old), chronically HBV-infected, meeting the criteria for antiviral therapy Group 1: 25 persons starting TDF with creatinine clearances between 50-80 mL/min Group 2: 25 persons starting TDF with creatinine clearances of > 80 mL/min Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria Renal clearance (CG) < 50 mL/min, HIV- and/or HCV-co infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to compare the incidence of KPTD in mildly renally impaired HBV-infected persons on TDF to the incidence in renally sufficient HBV-infected persons on TDF.;Secondary Objective: Secondary goals are to relate tenofovir plasma, intracellular and urine levels to the incidence of KPTD, to evaluate the incidence of KPTD in the first year of treatment and to evaluate bone demineralisation in the first year of treatment in mildly renally impaired HBV-infected persons on TDF and in renally sufficient HBV-infected persons on TDF.;Primary end point(s): The occurrence of kidney proximal tubular dysfunction (KPTD). KPTD is defined as the presence of at least two of the following; a decreased renal threshold phosphate concentration (TmP/GFR < 0.80 mmol/L), any normoglycemic (<10 mmol/L) glycosuria, hyperaminoaciduria, hyper ß2-microglobulinuria (normal < 400 µg/L), increased retinol binding protein loss (normal < 0.017 mg RBP/mmol creatinine), hyperuricosuria (normal < 5 mmol/24h).;Timepoint(s) of evaluation of this end point: 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The values of plasma TFV, urine TFV and intracellular TFV-DP levels in both study groups. - 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 study groups.;Timepoint(s) of evaluation of this end point: At 4, 12, 24, 36 and 48 weeks after initiation of therapy. | — |
Countries
Netherlands
Contacts
Public ContactClinical Research Bureau MDL
Erasmus MC
Outcome results
None listed