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

Phase 4

• Conditions: Investigate the Renal Effect of DAAs on Egyption Patients After Completion of Treatment
• Interventions: Other: evaluation of sofuspovir containing DAA regien expected insult on kidney

• Registration Number: NCT04267458
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2020-01-26
• Status Verified: 2020-02
• Study First Submitted QC: 2020-02-11
• Last Update Submitted: 2020-02-11
• Study First Posted: 2020-02-12
• Last Update Posted: 2020-02-12
• Primary Completion: 2020-04-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HCV infected patients with non-elevated sCr than basal levels	evaluation of sofuspovir containing DAA regien expected insult on kidney	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

Primary Outcome Measures

Name	Time	Method
investigate the renal injury which can be caused during using sofuspovir containing DAA regimen in HCV treatment	from the start to 6 months later	to investigate effect of DAA on kidney of treated patients and the mechanism of the drug to cause this renal effect by causing renal buimarkers including NAG and eGFR

Secondary Outcome Measures

Name	Time	Method
highlight the effect of DAAs on insulin resistance in diabetic patients suffering from HCV	from the starting of treatment till the 3-months follow up after the end of the treatment regimen	to estimate the effect of DAAs on HOMA-IR index f insulin resistance in diabetic infected patients and comparing their insulin resistance before and after treatment

Trial Locations

Locations (1)

Thabet Thabet Hospital For Internal Diseases; 🇪🇬 Cairo, Egypt