Status:
COMPLETED
Assessment and Monitoring of Renal Proximal Tubular Tolerance of Nucleoside and Nucleotide Analogues Using Early Screening Tools in Patients Chronically Mono-infected With Hepatitis B Virus
Lead Sponsor:
University Hospital, Limoges
Conditions:
Hepatitis B
Renal Failure With Tubular Necrosis
Eligibility:
All Genders
18+ years
Brief Summary
Nucleotide analogues are associated in the long term with a risk of proximal tubular nephropathy (PT) with loss of phosphate, and, when compensatory mechanisms are overwhelmed, with osteopenia or oste...
Detailed Description
260 naive untreated patients, 220 patients treated with TDF and 220 patients treated with ETV and consecutively recruited in this interventional study, will have at baseline and every three months, a ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Patients with chronic HBV virus monoinfected
- For groups of patients treated: Patients with an indication of ETV or TDF
- For the group of naive patients: treatment-naive patients who have no indication of treatment (or do not want) for the duration of the study
- globular filtration rate (GFR) ≥ 50 ml / min / 1.73 m2 with no known cause of renal disease
- Patients who have given their informed and written informed consent
- Women of childbearing potential with an effective method of contraception without interruption for the duration of the research and during the 4 months after stopping treatment
Exclusion
- Patients co-infected with HIV, hepatitis C or hepatitis Delta
- Patients who have already received the TDF in the group to receive the TDF and having already received ETV in the group to receive ETV
- Patient with a GFR \<50 ml / min / 1.73 m2 or with known causes of renal disease
- Patient with hypophosphatemia \<0.48 mmol / l
- Patients with hepatocellular carcinoma (diagnosed or suspected)
Key Trial Info
Start Date :
December 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT01500265
Start Date
December 1 2011
End Date
December 1 2015
Last Update
February 24 2016
Active Locations (25)
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1
CHU d'Amiens
Amiens, France, 80054
2
CHU d'Angers
Angers, France, 49933
3
CHU de Besancon
Besançon, France, 25000
4
CHU de Bordeaux - Hôpital Saint André
Bordeaux, France, 33000