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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05735093
Other study ID # 2022/009
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2023
Est. completion date February 1, 2024

Study information

Verified date February 2023
Source Kirikkale University
Contact BETUL DENIZ GOZMEN
Phone +905050910351
Email peynir@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 98
Est. completion date February 1, 2024
Est. primary completion date January 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Kirikkale University Kirikkale Yahsihan

Sponsors (1)

Lead Sponsor Collaborator
Kirikkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Renal Survival Dobling of serum creatinine and kidney replacement therapy initiation 12 months
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