Dcr3 Levels in Blood and Urine on Renal and Patient Prognosis in Patients With Acute Kidney Injury

Sponsor
Kırıkkale University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05735093
Collaborator
(none)
98
1
12
8.2

Study Details

Study Description

Brief Summary

Kidney diseases represent a global public health problem due to the aging of the population, the increasing prevalence of diabetes, hypertension, obesity and immune disorders. TNF-superfamily ligands are heterotrimeric transmembrane proteins with a molecular structure characterized by the presence of a TNF homology domain that binds to cysteine-rich regions of specific TNF-superfamily receptors. The tumor necrosis factor (TNF) superfamily consists of ligands and receptors that modulate adaptive immunity regulation, hematopoiesis, morphogenesis, as well as different disease states, including cancer and diabetes. DcR3 is found increased in a variety of cancer cells and various inflammatory tissues and is considered a potential biomarker to predict inflammatory disease progression and cancer metastasis. While increasing DcR3 expression may be possible to treat inflammatory diseases and enhance tissue repair, decreasing DcR3 expression may increase tumor apoptosis and suppress tumor growth in vivo. The study will be carried out with the prospective examination of patients without anuria and who developed Acute Kidney Injury or on the basis of Acute Kidney Disease on Chronic Kidney Disease. Sixty patients and 30 age- and gender matched control healthy individuals that accept enrollment in the study will be followed up by the Nephrology Department in Kırıkkale University Faculty of Medicine for 2 years. The aim of this study was to investigate the relationship between blood and urine DcR 3 levels on the effects of renal and patient prognosis in patients with Acute Kidney Injury as a predictor or an auxiliary test in prediction.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Kidney diseases represent a global public health problem due to the aging of the population, the increasing prevalence of diabetes, hypertension, obesity and immune disorders. TNF-superfamily ligands are heterotrimeric transmembrane proteins with a molecular structure characterized by the presence of a TNF homology domain that binds to cysteine-rich regions of specific TNF-superfamily receptors. The tumor necrosis factor (TNF) superfamily consists of ligands and receptors that modulate adaptive immunity regulation, hematopoiesis, morphogenesis, as well as different disease states, including cancer and diabetes. DcR3 is found increased in a variety of cancer cells and various inflammatory tissues and is considered a potential biomarker to predict inflammatory disease progression and cancer metastasis. While increasing DcR3 expression may be possible to treat inflammatory diseases and enhance tissue repair, decreasing DcR3 expression may increase tumor apoptosis and suppress tumor growth in vivo. The study will be carried out with the prospective examination of patients without anuria and who developed Acute Kidney Injury or on the basis of Acute Kidney Disease on Chronic Kidney Disease. Sixty patients and 30 age- and gender matched control healthy individuals that accept enrollment in the study will be followed up by the Nephrology Department in Kırıkkale University Faculty of Medicine for 2 years. The aim of this study was to investigate the relationship between blood and urine DcR 3 levels on the effects of renal and patient prognosis in patients with Acute Kidney Injury as a predictor or an auxiliary test in prediction.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    98 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Effect of Dcr3 Levels in Blood and Urine on Renal and Patient Prognosis in Patients With Acute Kidney Injury
    Actual Study Start Date :
    Feb 1, 2023
    Anticipated Primary Completion Date :
    Jan 31, 2024
    Anticipated Study Completion Date :
    Feb 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Renal Survival [12 months]

      Dobling of serum creatinine and kidney replacement therapy initiation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients 18 years and older

    • Agree to participate in the study

    • Patients with previously normal kidney function and Chronic Kidney Disease patients not receiving replacement therapy

    • The patient is not anuric

    • Malignant and inflammatory, autoimmune disease not having a history.

    Exclusion Criteria:
    • Non-Acute kidney injury dialysis procedures (Intox etc.)

    • Chronic kidney disease patients receiving dialysis treatment

    • Renal replacement therapy was started due to acute kidney injury in an external center, patients referred to our center

    • Pediatric age patients

    • Malignancy

    • Chronic inflammatory and autoimmune disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kirikkale University Kirikkale Yahsihan Turkey 71450

    Sponsors and Collaborators

    • Kırıkkale University

    Investigators

    • Study Chair: UCLER KISA, Prof, Kırıkkale University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Betul Deniz Gozmen, Dr Betul Deniz Gozmen, Kırıkkale University
    ClinicalTrials.gov Identifier:
    NCT05735093
    Other Study ID Numbers:
    • 2022/009
    First Posted:
    Feb 21, 2023
    Last Update Posted:
    Feb 21, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Betul Deniz Gozmen, Dr Betul Deniz Gozmen, Kırıkkale University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 21, 2023