Acute Kidney InjuryNCT05735093
Dcr3 Levels in Blood and Urine on Renal and Patient Prognosis in Patients With Acute Kidney Injury
An observational study of Acute Kidney Injury, run by Kırıkkale University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18-90 years old Male and female Patients with acute kidney injury
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kirikkale University
Kirikkale, Yahsihan, 71450
ARİF ALPER KIRKPANTUR, +905065028795, alperkirkpantur@yahoo.com
About this study
Official title: The Effect of Dcr3 Levels in Blood and Urine on Renal and Patient Prognosis in Patients With Acute Kidney Injury
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.
Read the 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.
- Conditions
- Acute Kidney Injury
- Keywords
- DcR levels, renal prognosis, patient survival, acute kidney injury
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal Survival
Dobling of serum creatinine and kidney replacement therapy initiation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Feb 2023
- Primary completion31 Jan 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betul Deniz Gozmen, Kırıkkale University
- Investigators
- UCLER KISA, Prof, Study chair, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735093
- Sponsor's protocol ID
- 2022/009
- Status last verified
- Feb 2023
- First submitted
- 9 Feb 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dcr3 Levels in Blood and Urine on Renal and Patient Prognosis in Patients With Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT05735093
- Acronym / sponsor ID
- 2022/009
- Conditions
- Acute Kidney Injury
- Keywords
- DcR levels, renal prognosis, patient survival, acute kidney injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18-90 years old Male and female Patients with acute kidney injury
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Renal Survival
Time frame: 12 months
Dobling of serum creatinine and kidney replacement therapy initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
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Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
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Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCLER KISA, Prof study chair
Kırıkkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Kırıkkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BETUL DENIZ GOZMEN (+905050910351, peynir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal Survival (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.