跳至主要内容
临床试验/NCT05276700
NCT05276700Unknown不适用

Alpha -1- Microglobulin (α1M) as an Early Biomarker in Renal Extrahepatic Manifestations of HCV-infection

Assiut University0 个研究点目标入组 170 人开始时间: 2022年7月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
170
主要终点
to identify and evaluate the prevalence of early renal manifestations among patients with chronic HCV by using alpha one microglobulin (as an early renal tubular biomarker).

研究概览

简要总结

find the role of alpha one microglobulin (as an early renal tubular biomarker) to identify and evaluate the prevalence of early renal manifestations among patients with chronic HCV and compared these patients with HCV-negative healthy individuals

详细描述

Hepatitis C [HCV] infection is known to cause renal manifestations, which are discovered at a late stage when chronic kidney disease (CKD) has already occurred .

HCV is both a consequence and cause of renal impairment: first, dialysis patients have an increased risk of infection related to medical procedures and, second, HCV causes pathological changes to the kidneys .

HCV seems to influence both renal tubular and glomerular cells as described by different proteinuria profiles and hematuria findings. Tubular cell damage may be the earliest sign of renal dysfunction caused by HCV and could potentially be used to identify patients with risk for progression. Routine urine analysis could be used to identify high risk HCV patients for early treatment.

Identifying patients early is of paramount importance in order to offer a prompt intervention and to improve the prognosis in both settings, for this purposes, novel biomarkers could be used One promising biomarker is alpha-1-microglobulin (α1m), a low molecular weight glycosylated protein of molecular weight synthesized by hepatocytes, freely filtered across the glomerulus, and then reabsorbed by the proximal tubule . it can signal proximal tubule dysfunction: higher Uα1m concentrations indicate impaired tubular reabsorption . Small studies have previously shown that Uα1m concentrations increase in Acute kidney injury (AKI), reflect severity of AKI, and are associated with the need for dialysis after nonoliguric AKI . Elevated Uα1m correlates with interstitial fibrosis and tubular atrophy on kidney biopsy, representing chronic kidney damage . Furthermore, Uα1m appears to predict kidney function decline and CKD progression , Acute kidney injury risk and also associated with early tubulointerstitial renal diseases in HCV-glomerulopathy .

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hepatitis C virus (HCV )-positive patients: HCV Antibody and status confirmed by HCV-RNA positive who are either treatment naïve or previously treated.
  • HCV-negative control at outpatients.

排除标准

  • HIV-positive patients or Hepatitis B positive (HbsAg) patients or both.
  • Previous renal diseases.
  • Diabetes mellitus, Hypertension, Systemic Lupus erythematosus, Rheumatoid arthritis.
  • patients with Active malignancy.
  • Alcoholics.

结局指标

主要结局

to identify and evaluate the prevalence of early renal manifestations among patients with chronic HCV by using alpha one microglobulin (as an early renal tubular biomarker).

时间窗: marsh 2022 - February 2024

to identify and evaluate the prevalence of early renal manifestations among patients with chronic HCV by using alpha one microglobulin (as an early renal tubular biomarker).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ghada Safwat

principal investigator

Assiut University

相似试验