The Renal Safety in Patients With Chronic HCV Undergoing Sofosbuvir Containing Antiviral Therapy

Egyptian Patients, HCV Treatment, Kidney Function Clinical Trial

Official title:

The Renal Safety and Rates of Acute Kidney Injury (AKI) in Patients With Chronic HCV Undergoing Sofosbuvir Containing Direct Acting Antiviral Therapy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04169464
• Other study ID #: ID22218
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: April 1, 2019
• Est. completion date: December 2019

Study information

• Verified date: November 2019
• Source: MTI University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the occurrence of AKI during antiviral therapy, when compared with baseline values in Egyptian patients.

In addition, the study aims to evaluate the change in insulin resistance value after treating patients from HCV.

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 (Brawn et al., 2018).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age= 18 years Chronic infection with HCV GT 4 No prior HCV treatment experience

Exclusion Criteria:

• Co-infection with HBV or HIV, clinical evidence of ischemic heart disease, the presence of diabetic ketoacidosis, Patients admitted to the intensive care unit (ICU), or expected to undergo surgery during the study period, and Child Pough score C.

Related Conditions & MeSH terms

• Egyptian Patients, HCV Treatment, Kidney Function

Intervention

Drug:
• Sofosbuvir Oral Product
to investigate the drug effect on renal function and insulin resistance

Locations

Country	Name	City	State
Egypt	Thabet Thabet hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
MTI University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurance of AKI during therapy	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.	3 months