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

• ClinicalTrials.gov Identifier: NCT04169464
• Recruitment Status: Enrolling by invitation
• First Posted: November 19, 2019
• Last Update Posted: November 19, 2019
• Sponsor: MTI University
• Information provided by (Responsible Party): Dalia Kamal Zaafar Ali, MTI University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Egyptian Patients, HCV Treatment, Kidney Function	Drug: Sofosbuvir Oral Product	Phase 4

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 (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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Renal Safety and Rates of Acute Kidney Injury (AKI) in Patients With Chronic HCV Undergoing Sofosbuvir Containing Direct Acting Antiviral Therapy
• Actual Study Start Date: April 1, 2019
• Estimated Primary Completion Date: November 2019
• Estimated Study Completion Date: December 2019

Arms and Interventions

Arm	Intervention/treatment
group I; A group of HCV infected patients treated with DAA therapy including Sofospovir	Drug: Sofosbuvir Oral Product; to investigate the drug effect on renal function and insulin resistance

Outcome Measures

Primary Outcome Measures :

1. occurance of AKI during therapy [ Time Frame: 3 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Egypt

Thabet Thabet hospital

Cairo, Egypt, 11311

Sponsors and Collaborators

MTI University

Investigators

• Principal Investigator: Dalia Zaafar, Phd; Lecturer of pharmacology and toxicology

More Information

• Responsible Party: Dalia Kamal Zaafar Ali, Lecturer of Pharmacology and Toxicology, MTI University
• ClinicalTrials.gov Identifier: NCT04169464
• Other Study ID Numbers: ID22218
• First Posted: November 19, 2019
• Last Update Posted: November 19, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: IPD are accepted to be shared in some cases where patients code only used without individual name

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dalia Kamal Zaafar Ali, MTI University:

HCV; DAAs; Egyptian patients; creatinine; insulin resistence; GFR

Additional relevant MeSH terms:

Sofosbuvir; Antiviral Agents; Anti-Infective Agents