NCT05735093

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 1, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

12 months

First QC Date

February 9, 2023

Last Update Submit

February 9, 2023

Conditions

Keywords

DcR levels, renal prognosis, patient survival, acute kidney injury

Outcome Measures

Primary Outcomes (1)

  • Renal Survival

    Dobling of serum creatinine and kidney replacement therapy initiation

    12 months

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

18-90 years old Male and female Patients with acute kidney injury

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kirikkale University

Kırıkkale, Yahsihan, 71450, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • UCLER KISA, Prof

    Kırıkkale University

    STUDY CHAIR

Central Study Contacts

BETUL DENIZ GOZMEN

CONTACT

ARİF ALPER KIRKPANTUR, Prof

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Betul Deniz Gozmen

Study Record Dates

First Submitted

February 9, 2023

First Posted

February 21, 2023

Study Start

February 1, 2023

Primary Completion

January 31, 2024

Study Completion

February 1, 2024

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations