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Safety of Sofosbuvir in People With Advanced Kidney Failure

NCT03883698 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-04-06

No results posted yet for this study

Summary

Infection with hepatitis C virus (HCV), a hepatotropic RNA virus, is often chronic, and causes liver cirrhosis and liver cancer. The virus is transmitted through parenteral exposure. This infection is particularly common in those on maintenance hemodialysis.

Sofosbuvir, an inhibitor of HCV RNA-dependent RNA polymerase, forms the backbone of DAA-based anti-HCV treatment regimens. In pre-clinical pharmacokinetic studies, administration of the usual 400 mg daily dose to in presence of advanced kidney failure (estimated glomerular filtration rate \[eGFR\] of \<30 ml/min) showed that serum levels of the sofosbuvir and GS-331007, the primary metabolite of sofosbuvir, were elevated by several folds. Hence, sofosbuvir is not approved for use in people on maintenance hemodialysis.

The newer DAAs (e.g. grazoprevir/elbasvir combination), which have been approved for use in people with eGFR \<30 ml/min, are very costly and are not available in Asian countries including India. Hence, as a rescue measures, several physicians, including our group, have tried half-daily dose (i.e, 200 mg daily or 400mg on alternate days) of sofosbuvir and 60 mg daclatasvir in dialysis-dependent people, with good results in terms of both safety and efficacy. In fact, the use of this empirical 200 mg daily dose schedule has become common in clinical practice. However, this use is not based on any pharmacokinetic data.

Hence, it is proposed to study the pharmacokinetics of low-dose (200 mg daily or 400 mg alternate day) of sofosbuvir and GS-331007 metabolite in people with eGFR \<30/min and active HCV infection.

Conditions

  • Kidney Failure, Chronic
  • Hepatitis C

Interventions

DRUG

Sofosbuvir

Sofosbuvir is the backbone of the most of the currently used anti-HCV treatment regimens

DRUG

Daclatasvir 60 mg

Daclatasvir, in combination with sofosbuvir, is approved for the treatment of hepatitis C virus infection in absence of liver cirrhosis

Sponsors & Collaborators

  • Sanjay Gandhi Postgraduate Institute of Medical Sciences

    lead OTHER_GOV

Principal Investigators

  • Amit Goel, DM · Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-15
Primary Completion
2020-08-01
Completion
2020-08-01

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03883698 on ClinicalTrials.gov