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

NCT ID: NCT04267458

Last Updated: 2020-02-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2020-12-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

HCV infected patients with non-elevated sCr than basal levels

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

Group Type: OTHER

evaluation of sofuspovir containing DAA regien expected insult on kidney

Intervention Type: OTHER

to use different kidney biomarkers to evaluate acute kidney damage after using sofuspovir containing DAA regimen in treatment of HCV

Interventions

evaluation of sofuspovir containing DAA regien expected insult on kidney

to use different kidney biomarkers to evaluate acute kidney damage after using sofuspovir containing DAA regimen in treatment of HCV

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Dalia K. Zaafar

lecturer of pharmacology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dalia Zaafar, PhD

Role: PRINCIPAL_INVESTIGATOR

Lecturer of pharmacology and toxicology

Locations

Thabet Thabet Hospital For Internal Diseases

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Dalia Zaafar, PhD

Role: CONTACT

dr.moda88@gmail.com

00201117922833

soha hassanin, PhD

Role: CONTACT

phsoha@hotmail.com

Facility Contacts

dalia zaafar, phd

Role: primary

dr.moda88@gmail.com

soha hassanin, phd

Role: backup

phsoha@hotmail.com

Other Identifiers

15-2019

Identifier Type: -

Identifier Source: org_study_id