Safety, Efficacy, and Changes in Traditional and Novel Biomarkers of Kidney Function in Patients With Hepatitis C and Advanced Chronic Kidney Disease Treated With Abbvie Viekira Pak or Mavyret Regimen
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Average Change in Urine Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment
研究概览
简要总结
Open-label experimental trial of 12 weeks of Viekira Pak treatment ± ribavirin or Mavyret for adults with chronic kidney disease and hepatitis C.
详细描述
The objective of this study is to evaluate the effect of paritaprevir/ritonavir, ombitasvir, dasabuvir (referred to as Viekira Pak) ± ribavirin or Glecaprevir / Pibrentasvir (referred to as Mavyret) for adults with advanced CKD with an estimated glomerular filtration rate (eGFR) less than 45ml/min that are infected with hepatitis C virus (HCV) genotype 1 and to determine the effect of treatment on traditional and novel markers of kidney function and cardiovascular disease risk in patients with advanced CKD. During the course of this prospective, single arm treatment trial, we will measure currently accepted markers of kidney function and novel biomarkers of CKD progression to determine if they improve with eradication of HCV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 year of age
- •HCV genotype 1 ≥ 1000 IU/mL
- •Estimated glomerular filtration rate 15-45mL/min/1.73m2 as estimated by CKD-Epi equation
排除标准
- •Pregnant or lactating females
- •Uncontrolled depression or psychiatric disease
- •History or presence of any form of cancer within 3 years of enrollment
- •Experiencing life-threatening cryoglobulinemic vasculitis requiring initiation of rituximab, steroids or plasmapheresis.
- •Uncontrolled cardiovascular or pulmonary disease
- •Experiencing symptoms attributed to uremia
- •Anticipated need to begin renal replacement therapy in the next 6 months
- •History of kidney transplant
研究组 & 干预措施
Viekira Pak ± ribavirin or Mavyret
12 week therapy with Viekira Pak ± ribavirin
8 or 12 week therapy with Mavyret
干预措施: Mavyret (Drug)
Viekira Pak ± ribavirin or Mavyret
12 week therapy with Viekira Pak ± ribavirin
8 or 12 week therapy with Mavyret
干预措施: Viekira Pak ± ribavirin (Drug)
结局指标
主要结局
Average Change in Urine Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment
时间窗: 52 Weeks
Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease. To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.
Average Change in Urine Interleukin (IL)-6 From Baseline to Post-treatment
时间窗: 52 weeks
Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease. To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.
Average Change in Plasma Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment
时间窗: 52 weeks
Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease. To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.
Average Change in Plasma Interferon Gamma-induced Protein 10 (IP-10) From Baseline to Post-treatment
时间窗: 52 Weeks 52 Weeks 52 weeks
Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease. To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.
Average Change in Plasma Interleukin (IL)-6 From Baseline to Post-treatment
时间窗: 52 weeks
Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease. To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.
Average Change in Plasma Interferon (IFN)-Gamma From Baseline to Post-treatment
时间窗: 52 weeks
Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease. To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.
次要结局
- Number of Patients Who Suffered Adverse Events Related to Study Drug (Safety and Tolerability)(12 weeks)
- Number of Patients Who Had Sustained Virologic Response at 12-weeks (SVR12) Post-treatment (Efficacy of Treatment)(24 weeks)
研究者
Raymond Chung
Director, Hepatology, Massachusetts General Hospital
Massachusetts General Hospital