Prevalence of Kidney Injury in Patients With HCV Treated With Sofuspovir Containing DAA Therapy
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|ClinicalTrials.gov Identifier: NCT04267458|
Recruitment Status : Recruiting
First Posted : February 12, 2020
Last Update Posted : February 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Investigate the Renal Effect of DAAs on Egyption Patients After Completion of Treatment||Other: evaluation of sofuspovir containing DAA regien expected insult on kidney||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.
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 :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||the Prevalence of Acute Kidney Injury in Patients With Chronic Hepatitis c Virus Receiving Sofuspovir Containing Direct Acting Antiviral Therapy|
|Actual Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||December 30, 2020|
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
Other: 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
- investigate the renal injury which can be caused during using sofuspovir containing DAA regimen in HCV treatment [ Time Frame: 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
- highlight the effect of DAAs on insulin resistance in diabetic patients suffering from HCV [ Time Frame: 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
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): NCT04267458
|Contact: Dalia Zaafar, PhDfirstname.lastname@example.org|
|Contact: soha hassanin, PhDemail@example.com|
|Principal Investigator:||Dalia Zaafar, PhD||Lecturer of pharmacology and toxicology|