the Prevalence of Acute Kidney Injury in Patients With Chronic Hepatitis c Virus Receiving Sofuspovir Containing Direct Acting Antiviral Therapy
试验速览
- 阶段
- 4 期
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- investigate the renal injury which can be caused during using sofuspovir containing DAA regimen in HCV treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients suffering from HCV
- •male or female
- •easy to treat naive patients
排除标准
- •pregnant women
- •seffering from HBV
- •diffecult to treat
- •other comorbodities as heart diseases or COPD
结局指标
主要结局
investigate the renal injury which can be caused during using sofuspovir containing DAA regimen in HCV treatment
时间窗: 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
次要结局
- highlight the effect of DAAs on insulin resistance in diabetic patients suffering from HCV(from the starting of treatment till the 3-months follow up after the end of the treatment regimen)
研究者
Dalia K. Zaafar
lecturer of pharmacology
Cairo University