NCT03883698

Safety of Sofosbuvir in People With Advanced Kidney Failure

Completed Phase 3 Last updated 6 April 2021

What this trial tests

Phase 3 trial testing Sofosbuvir in Kidney Failure, Chronic in 30 participants. Completed in 1 August 2020.

Timeline

15 March 2019

Primary endpoint
1 August 2020

1 August 2020

Quick facts

Lead sponsor	Sanjay Gandhi Postgraduate Institute of Medical Sciences
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	30
Start date	15 March 2019
Primary completion	1 August 2020
Estimated completion	1 August 2020
Sites	1 location across India

Drugs / interventions tested

• Sofosbuvir — full drug profile →
• Daclatasvir 60 mg — full drug profile →

Conditions studied

• Kidney Failure, Chronic — all drugs for Kidney Failure, Chronic →
• Hepatitis C — all drugs for Hepatitis C →

Sponsor

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Who can join

Adults 19 to 60, any sex, with Kidney Failure, Chronic or Hepatitis C. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.