AKI - Acute Kidney InjuryNCT06064487
Renal Cell Arrest and Damage Biomarkers in Progression and Outcome of Septic AKI
A study testing renal cell arrest and damage biomarkers assessment in people with AKI - Acute Kidney Injury, run by Alexandria University at 1 site in Egypt.
Trial summary
The aim of the current study is to assess the predictive value of renal cell arrest biomarkers (urinary TIMP2 and IGFBP7), renal damage biomarkers (urinary KIM-1) and microscopic examination of urinary sediment in progression and outcome of sepsis associated AKI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AKI - Acute Kidney Injury
- What is being tested?
- renal cell arrest and damage biomarkers assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 1 Jun 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AKI stage 1 or 2 according to KDIGO definition.
- Sepsis is defined based on the third international consensus definitions for sepsis and septic shock (Sepsis-3) as life threatening organ dysfunction caused by a dysregulated host response to infection. At least two of systemic inflammatory response syndrome (SIRS) criteria should be present
Who cannot join
- Age less than 18 years.
- Patients with pre-existing chronic kidney disease (eGFR<60 ml/min/1.73m2).
- Previous renal replacement therapy.
- Acute kidney injury caused by permanent postrenal obstruction.
- Pregnancy.
- Hepatorenal syndrome.
- Renal transplant recipients.
- Patients for whom survival to 30 days is unlikely due to end stage disease (end stage liver or heart disease or untreatable malignancy).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Renal Cell Arrest and Damage Biomarkers in Progression and Outcome of Sepsis Associated AKI
The aim of the current study is to assess the predictive value of renal cell arrest biomarkers (urinary TIMP2 and IGFBP7), renal damage biomarkers (urinary KIM-1) and microscopic examination of urinary sediment in progression and outcome of sepsis associated AKI.
Read the detailed description
Acute kidney injury occurred in about 45-53% of patients with sepsis, and most septic AKI was mild or moderate AKI (KDIGO stage 1 or stage 2).
However, previous study showed that up to 40% of these mild or moderate AKI would progress to more severe AKI (KDIGO stage 3), of which 30% required dialysis and the risk of death increased by 3-fold, as high as 70%. Therefore, early identifying patients at high risk for progressive AKI might help clinicians to enhance individualized monitoring and personalized management in patient with septic AKI, which might prevent or halt the ongoing renal injury and improve the outcome of patients with sepsis.
- Conditions
- AKI - Acute Kidney Injury
- Being tested
- renal cell arrest and damage biomarkers assessment
- Keywords
- AKI, sepsis, markers, urine sediment
- Medical subject headings
- Acute Kidney Injury, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal cell arrest and damage biomarkers assessmentDiagnostic test
measurement of TIMP2 and IGFBP7, KIM-1
| Study group | Role | What they receive |
|---|---|---|
| septic AKI patients | Experimental | 80 patients with sepsis associated AKI stage 1 or 2 according to KDIGO definition Receives: Diagnostic Test: renal cell arrest and damage biomarkers assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary TIMP2 and IGFBP7 estimation
both will be measured by the ELISA technique
Measured: 90 days
Urinary KIM-1 estimation
will be measured by the ELISA technique
Measured: 90 days
Examination of urine sediment
by calculating Perazella score
Measured: 7 days
progression of AKI
by assessing change in eGFR
Measured: 90 days
Examination of urine sediment
by calculating Chawla score
Measured: 7 days
Secondary outcomes (3)
need for renal replacement therapy
need of any dialysis modality
Measured: 90 days
mortality
death
Measured: 90 days
length of ICU and hospital stay
duration of stay
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start1 Oct 2023
- Primary completion1 Apr 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AKI - Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The current study will include 80 patients with sepsis associated AKI stage 1 or 2 according to KDIGO definition admitted to Alexandria Main University Hospital. Urinary TIMP2 and IGFBP7: will be measured by the ELISA technique. Urinary KIM-1: will be measured by the ELISA technique. Examination of urine sediment from fresh urine sample.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Alexandria University
- Investigators
- Hala S ElWakil, MD, Study chair, professorsalah s naga, MD, Principal investigator, professorMohamed mamdouh Elsayed, MD, Study chair, LecturerMona m tahoun, MD, Study chair, Lecturerahmed E El-deeb, Master, Study chair, assistant lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064487
- Sponsor's protocol ID
- markers of septic AKI
- Status last verified
- Jun 2024
- First submitted
- 21 Sep 2023
- Last updated
- 18 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gordon AC, Mason AJ, Thirunavukkarasu N, Perkins GD, Cecconi M, Cepkova M, Pogson DG, Aya HD, Anjum A, Frazier GJ, Santhakumaran S, Ashby D, Brett SJ; VANISH Investigators. Effect of Early Vasopressin vs Norepinephrine on Kidney Failure in Patients With Septic Shock: The VANISH Randomized Clinical Trial. JAMA. 2016 Aug 2;316(5):509-18. doi: 10.1001/jama.2016.10485.
PubMed 27483065Maizel J, Daubin D, Vong LV, Titeca-Beauport D, Wetzstein M, Kontar L, Slama M, Klouche K, Vinsonneau C. Urinary TIMP2 and IGFBP7 Identifies High Risk Patients of Short-Term Progression from Mild and Moderate to Severe Acute Kidney Injury during Septic Shock: A Prospective Cohort Study. Dis Markers. 2019 Apr 1;2019:3471215. doi: 10.1155/2019/3471215. eCollection 2019.
PubMed 31061681Gunnerson KJ, Shaw AD, Chawla LS, Bihorac A, Al-Khafaji A, Kashani K, Lissauer M, Shi J, Walker MG, Kellum JA; Sapphire Topaz investigators. TIMP2*IGFBP7 biomarker panel accurately predicts acute kidney injury in high-risk surgical patients. J Trauma Acute Care Surg. 2016 Feb;80(2):243-9. doi: 10.1097/TA.0000000000000912.
PubMed 26816218Elsayed MM, Eldeeb AE, Tahoun MM, El-Wakil HS, Naga SS. Does combining urine sediment examination to renal cell arrest and damage biomarkers improve prediction of progression and mortality of sepsis associated acute kidney injury? BMC Nephrol. 2025 Apr 17;26(1):195. doi: 10.1186/s12882-025-04096-1.
PubMed 40247231
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Renal Cell Arrest and Damage Biomarkers in Progression and Outcome of Sepsis Associated AKI
- ClinicalTrials.gov ID
- NCT06064487
- Acronym / sponsor ID
- markers of septic AKI
- Conditions
- AKI - Acute Kidney Injury
- Keywords
- AKI, sepsis, markers, urine sediment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 3 Oct 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.
The aim of the current study is to assess the predictive value of renal cell arrest biomarkers (urinary TIMP2 and IGFBP7), renal damage biomarkers (urinary KIM-1) and microscopic examination of urinary sediment in progression and outcome of sepsis associated AKI.
Detailed description
Acute kidney injury occurred in about 45-53% of patients with sepsis, and most septic AKI was mild or moderate AKI (KDIGO stage 1 or stage 2).
However, previous study showed that up to 40% of these mild or moderate AKI would progress to more severe AKI (KDIGO stage 3), of which 30% required dialysis and the risk of death increased by 3-fold, as high as 70%. Therefore, early identifying patients at high risk for progressive AKI might help clinicians to enhance individualized monitoring and personalized management in patient with septic AKI, which might prevent or halt the ongoing renal injury and improve the outcome of patients with sepsis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The current study will include 80 patients with sepsis associated AKI stage 1 or 2 according to KDIGO definition admitted to Alexandria Main University Hospital. Urinary TIMP2 and IGFBP7: will be measured by the ELISA technique. Urinary KIM-1: will be measured by the ELISA technique. Examination of urine sediment from fresh urine sample.
| Arm | Type | Receives |
|---|---|---|
| septic AKI patients | Experimental | Diagnostic Test: renal cell arrest and damage biomarkers assessment80 patients with sepsis associated AKI stage 1 or 2 according to KDIGO definition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- AKI stage 1 or 2 according to KDIGO definition.
- Sepsis is defined based on the third international consensus definitions for sepsis and septic shock (Sepsis-3) as life threatening organ dysfunction caused by a dysregulated host response to infection. At least two of systemic inflammatory response syndrome (SIRS) criteria should be present
Key exclusion criteria (8 listed)
- Age less than 18 years.
- Patients with pre-existing chronic kidney disease (eGFR<60 ml/min/1.73m2).
- Previous renal replacement therapy.
- Acute kidney injury caused by permanent postrenal obstruction.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| renal cell arrest and damage biomarkers assessmentmeasurement of TIMP2 and IGFBP7, KIM-1 | Diagnostic test | septic AKI patients |
Primary outcome
Urinary TIMP2 and IGFBP7 estimation
Time frame: 90 days
both will be measured by the ELISA technique
Urinary KIM-1 estimation
Time frame: 90 days
will be measured by the ELISA technique
Examination of urine sediment
Time frame: 7 days
by calculating Perazella score
progression of AKI
Time frame: 90 days
by assessing change in eGFR
Examination of urine sediment
Time frame: 7 days
by calculating Chawla score
3 secondary outcomes
need for renal replacement therapy
Time frame: 90 days
mortality
Time frame: 90 days
length of ICU and hospital stay
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Background: PubMed 27483065Gordon AC, Mason AJ, Thirunavukkarasu N, Perkins GD, Cecconi M, Cepkova M, Pogson DG, Aya HD, Anjum A, Frazier GJ, Santhakumaran S, Ashby D, Brett SJ; VANISH Investigators. Effect of Early Vasopressin vs Norepinephrine on Kidney Failure in Patients With Septic Shock: The VANISH Randomized Clinical Trial. JAMA. 2016 Aug 2;316(5):509-18. doi: 10.1001/jama.2016.10485.
- Background: PubMed 31061681Maizel J, Daubin D, Vong LV, Titeca-Beauport D, Wetzstein M, Kontar L, Slama M, Klouche K, Vinsonneau C. Urinary TIMP2 and IGFBP7 Identifies High Risk Patients of Short-Term Progression from Mild and Moderate to Severe Acute Kidney Injury during Septic Shock: A Prospective Cohort Study. Dis Markers. 2019 Apr 1;2019:3471215. doi: 10.1155/2019/3471215. eCollection 2019.
- Background: PubMed 26816218Gunnerson KJ, Shaw AD, Chawla LS, Bihorac A, Al-Khafaji A, Kashani K, Lissauer M, Shi J, Walker MG, Kellum JA; Sapphire Topaz investigators. TIMP2*IGFBP7 biomarker panel accurately predicts acute kidney injury in high-risk surgical patients. J Trauma Acute Care Surg. 2016 Feb;80(2):243-9. doi: 10.1097/TA.0000000000000912.
- Derived from this study: PubMed 40247231Elsayed MM, Eldeeb AE, Tahoun MM, El-Wakil HS, Naga SS. Does combining urine sediment examination to renal cell arrest and damage biomarkers improve prediction of progression and mortality of sepsis associated acute kidney injury? BMC Nephrol. 2025 Apr 17;26(1):195. doi: 10.1186/s12882-025-04096-1.
- Individual participant dataSharing planned: Undecided
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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.
Hala S ElWakil, MD study chair
professor
salah s naga, MD principal investigator
professor
Mohamed mamdouh Elsayed, MD study chair
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing renal cell arrest and damage biomarkers assessment in people with AKI - Acute Kidney Injury, run by Alexandria University at 1 site in Egypt.
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 18 Jun 2024. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary TIMP2 and IGFBP7 estimation (time frame: 90 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06064487, which also lists 4 linked publications.
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 18 Jun 2024.