NCT05276700

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

July 15, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

May 4, 2022

Status Verified

May 1, 2022

Enrollment Period

1.6 years

First QC Date

March 3, 2022

Last Update Submit

May 3, 2022

Conditions

Renal InjuryHCV

Outcome Measures

Primary Outcomes (1)

  • 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).

    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

Study Arms (2)

case with hcv

control without hcv

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

170 participants in 1:1 design (79 HCV positive patient were diagnosed as HCV positive by HCV+Abs and +ve real time PCR for HCV-RNA and 79 age and sex matched HCV negative as control, and fulfill the following inclusions criteria

You may qualify if:

  • 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.

You may not qualify if:

  • \- 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.
  • \. patients with Active malignancy. 5. Alcoholics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Cacoub P, Comarmond C. Considering hepatitis C virus infection as a systemic disease. Semin Dial. 2019 Mar;32(2):99-107. doi: 10.1111/sdi.12758. Epub 2018 Dec 13.

    PMID: 30549107BACKGROUND

  • Aguirre Valadez J, Garcia Juarez I, Rincon Pedrero R, Torre A. Management of chronic hepatitis C virus infection in patients with end-stage renal disease: a review. Ther Clin Risk Manag. 2015 Feb 27;11:329-38. doi: 10.2147/TCRM.S74282. eCollection 2015.

    PMID: 25767389BACKGROUND

  • Kaartinen K, Vuoti S, Honkanen E, Loyttyniemi E, Singh R, Farkkila M. Tubular cell damage may be the earliest sign of renal extrahepatic manifestation caused by Hepatitis C. PLoS One. 2021 May 7;16(5):e0251392. doi: 10.1371/journal.pone.0251392. eCollection 2021.

    PMID: 33961672BACKGROUND

  • Itoh Y, Kawai T. Human alpha 1-microglobulin: its measurement and clinical significance. J Clin Lab Anal. 1990;4(5):376-84. doi: 10.1002/jcla.1860040511.

    PMID: 1700091BACKGROUND

  • Weber MH, Verwiebe R. Alpha 1-microglobulin (protein HC): features of a promising indicator of proximal tubular dysfunction. Eur J Clin Chem Clin Biochem. 1992 Oct;30(10):683-91.

    PMID: 1283528BACKGROUND

  • Heise D, Rentsch K, Braeuer A, Friedrich M, Quintel M. Comparison of urinary neutrophil glucosaminidase-associated lipocalin, cystatin C, and alpha1-microglobulin for early detection of acute renal injury after cardiac surgery. Eur J Cardiothorac Surg. 2011 Jan;39(1):38-43. doi: 10.1016/j.ejcts.2010.05.044. Epub 2010 Jul 21.

    PMID: 20650648BACKGROUND

  • Amer H, Lieske JC, Rule AD, Kremers WK, Larson TS, Franco Palacios CR, Stegall MD, Cosio FG. Urine high and low molecular weight proteins one-year post-kidney transplant: relationship to histology and graft survival. Am J Transplant. 2013 Mar;13(3):676-84. doi: 10.1111/ajt.12044. Epub 2013 Feb 15.

    PMID: 23414180BACKGROUND

  • Bullen AL, Katz R, Lee AK, Anderson CAM, Cheung AK, Garimella PS, Jotwani V, Haley WE, Ishani A, Lash JP, Neyra JA, Punzi H, Rastogi A, Riessen E, Malhotra R, Parikh CR, Rocco MV, Wall BM, Bhatt UY, Shlipak MG, Ix JH, Estrella MM. The SPRINT trial suggests that markers of tubule cell function in the urine associate with risk of subsequent acute kidney injury while injury markers elevate after the injury. Kidney Int. 2019 Aug;96(2):470-479. doi: 10.1016/j.kint.2019.03.024. Epub 2019 May 7.

    PMID: 31262489BACKGROUND

Study Officials

  • Enas Alkareemy

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Ghada Safwat, master

CONTACT

01288348166ghadasafwat1714@gmail.com

essam mohamed Abdel Aziz

CONTACT

0 100 969 9081essam.nephro@gmail.Com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 3, 2022

First Posted

March 11, 2022

Study Start

July 15, 2022

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

May 4, 2022

Record last verified: 2022-05