The Renal Safety in Patients With Chronic HCV Undergoing Sofosbuvir Containing Antiviral Therapy
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|ClinicalTrials.gov Identifier: NCT04169464|
Recruitment Status : Enrolling by invitation
First Posted : November 19, 2019
Last Update Posted : November 19, 2019
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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04169464
|Thabet Thabet hospital|
|Cairo, Egypt, 11311|
|Principal Investigator:||Dalia Zaafar, Phd||Lecturer of pharmacology and toxicology|