Prevalence of Kidney Injury in Patients With HCV Treated With Sofuspovir Containing DAA Therapy

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: Investigate the Renal Effect of DAAs on Egyption Patients After Completion of Treatment

Treatments: Other: evaluation of sofuspovir containing DAA regien expected insult on kidney

Study type: Interventional

Funder types: Other

Identifiers

NCT04267458

15-2019

Details and patient eligibility

About

this study aims is to investigate the occurrence of AKI during antiviral therapy, defined as an increase of 0.3 mg/dL or 50% at least in serum creatinine level when compared with baseline values or more than a 25% reduction in (eGFR) when compared with baseline eGFR in Egyptian patients.In addition to evaluate the change in insulin resistance value after treating patients from HCV.

Full description

There are limited published data, currently, suggesting the risk of AKI during oral direct acting antiviral treatment. Most case reports and retrospective studies reported the presence of an intrinsic cause of renal injury, with most of the available biopsies showing acute tubular necrosis (ATN) and acute interstitial nephritis (AIN). Most of these patients had returned to baseline renal function on cessation of sofosbuvir combination therapy.

Recently it was found that a notable percentage of patients experienced a transient increase in creatinine during therapy, which could occasionally lead to a more than 50% decrease in patients' eGFR. Previous studies had also shown that the co-use of nonsteroidal anti-inflammatory drugs (NSAIDs) and recurrent ascites were at increased risk for AKI during sofosbuvir-based antiviral therapy.

The primary endpoint of this study is to investigate the occurrence of AKI in Egyptian patients during antiviral therapy and to highlight its reasons and time of incidence in addition to the mechanism of this injury.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients suffering from HCV
• male or female
• easy to treat naive patients

Exclusion criteria

• pregnant women
• seffering from HBV
• diffecult to treat
• other comorbodities as heart diseases or COPD

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

HCV infected patients with non-elevated sCr than basal levels

Other group

Description:

a group of egyption patients with HCV infection with non-elevated sCr than basal levels and treated with sofuspovir as an direct acting antiviral drug

Treatment:

Other: evaluation of sofuspovir containing DAA regien expected insult on kidney