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

• Conditions: Renal Injury; HCV

• Registration Number: NCT05276700
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

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 .

Study Timeline

• Study First Submitted: 2022-03-03
• Study First Submitted QC: 2022-03-03
• Study First Posted: 2022-03-11
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-04
• Study Start: 2022-07-15
• Primary Completion: 2024-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

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

3. HCV-negative control at outpatients.

Exclusion Criteria

• 1. HIV-positive patients or Hepatitis B positive (HbsAg) patients or both. 2. Previous renal diseases. 3. Diabetes mellitus, Hypertension, Systemic Lupus erythematosus, Rheumatoid arthritis.

4. patients with Active malignancy. 5. Alcoholics.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).	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).