SepsisNCT06498336
miRNA in Septic Acute Kidney Injury
An observational study of Sepsis and Acute Kidney Injury, run by University Hospital Ostrava at 2 sites in Czechia.
Trial summary
Acute kidney injury is a common and serious complication of sepsis and septic shock, which may be associated with a worse outcome of the patient's condition. The exact pathophysiological mechanism of septic acute kidney injury remains a challenge. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sepsis, Acute Kidney Injury, Acute Kidney Injury Due to Sepsis
- What is being tested?
- Laboratory examination to determine the presence of sepsis, Laboratory examination to determine the presence of sepsis and acute kidney injury and Laboratory examination to determine miRNA and biochemical parameters
- How many people
- 211 participants
- Where
- 2 sitesCzechia
- Study dates
- 2 May 2024to 31 Mar 2026
- 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 100 years
- All sexes
- Adult, Older adult
Study population: Critically ill adult patients suffering from sepsis defined according to SEPSIS 3 definition, with or without acute kidney injury defined by KDIGO 2012 (2) and healthy volunteers
Who may be able to join
- The study group of patients with sepsis with or without acute kidney injury
- age > 18 years
- newly diagnosed sepsis or septic shock with or without acute kidney injury
- Healthy volunteers
- no evidence of infection on clinical or laboratory examination
- age > 18 years
- signed informed consent
Who cannot join
- The study group of patients with sepsis with or without acute kidney injury
- age < 18 years
- chronic kidney disease at stage 4 or 5 according to KDIGO recommendations (KDIGO) for chronic kidney disease 2024
- patients on chronic dialysis treatment, or after renal transplantation
- Healthy volunteers
- acute or chronic infection
- renal disease
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites
University Hospital Olomouc
Olomouc, Olomouc Region, 779 00
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 708 52
About this study
Official title: Specific miRNA Associated With Endothelial Dysfunction and Mitochondrial Damage in Patients With Septic Acute Kidney Injury
Acute kidney injury is a common and serious complication of sepsis and septic shock, which may be associated with a worse outcome of the patient's condition. The exact pathophysiological mechanism of septic acute kidney injury remains a challenge. One of the possible causes appears to be endothelial dysfunction and mitochondrial damage of renal tubular cells. The aim of this study is to identify specific microRNAs associated with these pathophysiological events in sepsis and septic acute kidney injury. And to establish a new potential diagnostic or therapeutic target for the prevention or treatment of septic acute kidney injury.
Read the detailed description
Sepsis is generally characterized as a life-threatening organ dysfunction and dysregulating host reaction to the infection (e.g., bacterial, viral, mycotic (1). Typical pathophysiological processes of sepsis include systemic inflammation, immune suppression, activation of the clotting cascade, and increase of endothelial vascular permeability with subsequent leak of fluids into the interstitial space. One of the most important organ damage due to ongoing sepsis is acute kidney injury (AKI), which is also a predictor of mortality in critically ill patients. The exact pathophysiology of septic AKI remains a challenging and poorly understood mechanism. A decrease of oxygen delivery to the tissues during the septic shock and usually high oxygen consumption of renal tubular cells make them prone to ischemia injury with consequences in tubular cell death. Among potential immune inflammatory response biomarkers in sepsis and septic shock might be promising pentraxin 3 (PTX3), which plays an important role in endothelial dysfunction with several pathogenic pathways' activation. Recently has been shown the positive effect of PTX3 on the inhibition of reactive oxygen species, mitochondrial injury, and apoptosis pathway in AKI (3,4). Another promising urinary or serum biomarker of AKI seems to be uromodulin, which is dynamically regulated in response to sepsis. Serum uromodulin concentrations decrease during septic human AKI development and are associated with increased renal and systemic oxidative damage (5,6,7). MicroRNAs are small non-coding RNAs, that have been reported to be useful biomarkers for AKI development or potential target for AKI treatment. Determination of serum PTX3 and uromodulin concomitantly with specific circulating miRNAs associated with PTX3 and uromodulin-specific signaling pathways in critically ill septic patients could bring new insights to septic AKI pathophysiology and contribute to future development of new preventive or therapeutic options in septic patients.
- Being tested
- Laboratory examination to determine the presence of sepsis, Laboratory examination to determine the presence of sepsis and acute kidney injury, Laboratory examination to determine miRNA and biochemical parameters
- Keywords
- acute kidney injury, endothelial dysfunction, mitochondrial damage, Pentraxin 3, miRNA, sepsis, uromodulin
- Medical subject headings
- Sepsis, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory examination to determine the presence of sepsisDiagnostic test
Standard laboratory biochemical methods will be used to determine sepsis diagnosis accord-ing to SEPSIS 3 (1). Blood samples for obtaining serum/plasma of the patients will be taken on the 1st and 4th day of sepsis diagnosis.
Laboratory examination to determine the presence of sepsis and acute kidney injuryDiagnostic test
Standard laboratory biochemical methods will be used to determine sepsis diagnosis according to SEPSIS 3 and acute kidney injury according to Guidelines Kidney Disease Improving Global Outcomes (KDIGO) 2012 (2). Blood samples for obtaining serum/plasma of the patients will be taken on the 1st and 4th day of sepsis diagnosis.
Laboratory examination to determine miRNA and biochemical parametersDiagnostic test
Laboratory examination will be performed to determine miRNA and biochemical parameters.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill adult septic patients without acute kidney injury | The patients in this group will be screened clinically and by standard laboratory biochemical methods to determine sepsis diagnosis according to SEPSIS 3 (1). Blood samples for obtaining serum/plasma of the patients will be taken on the 1st and 4th day of sepsis diagnosis. Receives: Diagnostic Test: Laboratory examination to determine the presence of sepsis | |
| Critically ill adult septic patients with acute kidney injury | The patients will be screened clinically and by standard laboratory biochemical methods to determine sepsis diagnosis according to SEPSIS 3 and acute kidney injury according to KDIGO 2012 (2). Blood samples for obtaining serum/plasma of the patients will be taken on the 1st and 4th day of sepsis diagnosis. Receives: Diagnostic Test: Laboratory examination to determine the presence of sepsis and acute kidney injury | |
| Healthy volunteers | The blood samples for miRNA and biochemical parameters will be collected once, after randomization. Receives: Diagnostic Test: Laboratory examination to determine miRNA and biochemical parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of serum expression of pentraxin 3 (PTX3) and uromodulin
To determine the concentration of serum PTX3 and serum uromodulin in critically ill septic patients and their comparison to serum concentrations of creatinine and the acute kidney injury (AKI) stage as well as to the concentrations of procalcitonin (PCT) and interleukin-6 (IL-6) as inflammation markers on day 1 and 4 of study. The serum concentrations of PTX3 and uromodulin in ng/mL will be determined also in healthy volunteers to establish the laboratory reference ranges (values).
Measured: 4 days
Determination of expression and 4 days course investigation of miRNAs
To determine the expression and 4-day time course investigation of 7 specific circulating miRNAs associated with sepsis and septic acute kidney injury from 352 miRNA targets using a two-tailed Quantitative reverse transcription polymerase chain reaction (RT-qPCR). All selected miRNAs will be determined also in healthy volunteers to establish the laboratory reference ranges (values).
Measured: 4 days
Target genes of miRNAs and their association with endothelial dysfunction and mitochondrial injury in sepsis
To match the target genes (from miRNA database) of these specifically expressed miRNAs with biochemical pathways associated with serum PTX3 and uromodulin involved in endothelial dysfunction of renal microvasculature, the influence of mitochondrial injury/dysfunction with reactive oxygen species production and activation of cell apoptosis in septic acute kidney injury.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start2 May 2024
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Olomouc
- Responsible party
- Sponsor
- Investigators
- Naděžda Petejová, Assoc.Prof.,MD,PhD,MSc, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498336
- Sponsor's protocol ID
- INT-01-sepsis-miRNA
- Other IDs
- RVO-FNOs/2024
- Status last verified
- Jun 2026
- First submitted
- 27 Jun 2024
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Publications
Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
PubMed 26903338Chen J, Matzuk MM, Zhou XJ, Lu CY. Endothelial pentraxin 3 contributes to murine ischemic acute kidney injury. Kidney Int. 2012 Dec;82(11):1195-207. doi: 10.1038/ki.2012.268. Epub 2012 Aug 15.
PubMed 22895517Lee HH, Kim SY, Na JC, Yoon YE, Han WK. Exogenous pentraxin-3 inhibits the reactive oxygen species-mitochondrial and apoptosis pathway in acute kidney injury. PLoS One. 2018 Apr 19;13(4):e0195758. doi: 10.1371/journal.pone.0195758. eCollection 2018.
PubMed 29672566El-Achkar TM, Wu XR, Rauchman M, McCracken R, Kiefer S, Dagher PC. Tamm-Horsfall protein protects the kidney from ischemic injury by decreasing inflammation and altering TLR4 expression. Am J Physiol Renal Physiol. 2008 Aug;295(2):F534-44. doi: 10.1152/ajprenal.00083.2008. Epub 2008 May 21.
PubMed 18495803LaFavers KA, Hage CA, Gaur V, Micanovic R, Hato T, Khan S, Winfree S, Doshi S, Moorthi RN, Twigg H, Wu XR, Dagher PC, Srour EF, El-Achkar TM. The kidney protects against sepsis by producing systemic uromodulin. Am J Physiol Renal Physiol. 2022 Aug 1;323(2):F212-F226. doi: 10.1152/ajprenal.00146.2022. Epub 2022 Jun 27.
PubMed 35759740LaFavers KA, Macedo E, Garimella PS, Lima C, Khan S, Myslinski J, McClintick J, Witzmann FA, Winfree S, Phillips CL, Hato T, Dagher PC, Wu XR, El-Achkar TM, Micanovic R. Circulating uromodulin inhibits systemic oxidative stress by inactivating the TRPM2 channel. Sci Transl Med. 2019 Oct 2;11(512):eaaw3639. doi: 10.1126/scitranslmed.aaw3639.
PubMed 31578243Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int. 2024 Apr;105(4S):S117-S314. doi: 10.1016/j.kint.2023.10.018. No abstract available.
PubMed 38490803
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific miRNA Associated With Endothelial Dysfunction and Mitochondrial Damage in Patients With Septic Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT06498336
- Acronym / sponsor ID
- INT-01-sepsis-miRNA
- Keywords
- acute kidney injury, endothelial dysfunction, mitochondrial damage, Pentraxin 3, miRNA, sepsis, uromodulin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Collaborators
- University Hospital Olomouc
- Study start
- 2 May 2024 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 12 Jul 2024 (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.
Acute kidney injury is a common and serious complication of sepsis and septic shock, which may be associated with a worse outcome of the patient's condition. The exact pathophysiological mechanism of septic acute kidney injury remains a challenge. One of the possible causes appears to be endothelial dysfunction and mitochondrial damage of renal tubular cells. The aim of this study is to identify specific microRNAs associated with these pathophysiological events in sepsis and septic acute kidney injury. And to establish a new potential diagnostic or therapeutic target for the prevention or treatment of septic acute kidney injury.
Detailed description
Sepsis is generally characterized as a life-threatening organ dysfunction and dysregulating host reaction to the infection (e.g., bacterial, viral, mycotic (1). Typical pathophysiological processes of sepsis include systemic inflammation, immune suppression, activation of the clotting cascade, and increase of endothelial vascular permeability with subsequent leak of fluids into the interstitial space. One of the most important organ damage due to ongoing sepsis is acute kidney injury (AKI), which is also a predictor of mortality in critically ill patients. The exact pathophysiology of septic AKI remains a challenging and poorly understood mechanism. A decrease of oxygen delivery to the tissues during the septic shock and usually high oxygen consumption of renal tubular cells make them prone to ischemia injury with consequences in tubular cell death. Among potential immune inflammatory response biomarkers in sepsis and septic shock might be promising pentraxin 3 (PTX3), which plays an important role in endothelial dysfunction with several pathogenic pathways' activation. Recently has been shown the positive effect of PTX3 on the inhibition of reactive oxygen species, mitochondrial injury, and apoptosis pathway in AKI (3,4). Another promising urinary or serum biomarker of AKI seems to be uromodulin, which is dynamically regulated in response to sepsis. Serum uromodulin concentrations decrease during septic human AKI development and are associated with increased renal and systemic oxidative damage (5,6,7). MicroRNAs are small non-coding RNAs, that have been reported to be useful biomarkers for AKI development or potential target for AKI treatment. Determination of serum PTX3 and uromodulin concomitantly with specific circulating miRNAs associated with PTX3 and uromodulin-specific signaling pathways in critically ill septic patients could bring new insights to septic AKI pathophysiology and contribute to future development of new preventive or therapeutic options in septic patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Critically ill adult septic patients without acute kidney injury | – | Diagnostic Test: Laboratory examination to determine the presence of sepsisThe patients in this group will be screened clinically and by standard laboratory biochemical methods to determine sepsis diagnosis according to SEPSIS 3 (1). Blood samples for obtaining serum/plasma of the patients will be taken on the 1st and 4th day of sepsis diagnosis. |
| Critically ill adult septic patients with acute kidney injury | – | Diagnostic Test: Laboratory examination to determine the presence of sepsis and acute kidney injuryThe patients will be screened clinically and by standard laboratory biochemical methods to determine sepsis diagnosis according to SEPSIS 3 and acute kidney injury according to KDIGO 2012 (2). Blood samples for obtaining serum/plasma of the patients will be taken on the 1st and 4th day of sepsis diagnosis. |
| Healthy volunteers | – | Diagnostic Test: Laboratory examination to determine miRNA and biochemical parametersThe blood samples for miRNA and biochemical parameters will be collected once, after randomization. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Critically ill adult patients suffering from sepsis defined according to SEPSIS 3 definition, with or without acute kidney injury defined by KDIGO 2012 (2) and healthy volunteers
Key inclusion criteria (7 listed)
- The study group of patients with sepsis with or without acute kidney injury
- age > 18 years
- newly diagnosed sepsis or septic shock with or without acute kidney injury
- Healthy volunteers
- no evidence of infection on clinical or laboratory examination
Key exclusion criteria (7 listed)
- The study group of patients with sepsis with or without acute kidney injury
- age < 18 years
- chronic kidney disease at stage 4 or 5 according to KDIGO recommendations (KDIGO) for chronic kidney disease 2024
- patients on chronic dialysis treatment, or after renal transplantation
- Healthy volunteers
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 |
|---|---|---|
| Laboratory examination to determine the presence of sepsisStandard laboratory biochemical methods will be used to determine sepsis diagnosis accord-ing to SEPSIS 3 (1). Blood samples for obtaining serum/plasma of the patients will be taken on the 1st and 4th day of sepsis diagnosis. | Diagnostic test | Critically ill adult septic patients without acute kidney injury |
| Laboratory examination to determine the presence of sepsis and acute kidney injuryStandard laboratory biochemical methods will be used to determine sepsis diagnosis according to SEPSIS 3 and acute kidney injury according to Guidelines Kidney Disease Improving Global Outcomes (KDIGO) 2012 (2). Blood samples for obtaining serum/plasma of the patients will be taken on the 1st and 4th day of sepsis diagnosis. | Diagnostic test | Critically ill adult septic patients with acute kidney injury |
| Laboratory examination to determine miRNA and biochemical parametersLaboratory examination will be performed to determine miRNA and biochemical parameters. | Diagnostic test | Healthy volunteers |
Primary outcome
Determination of serum expression of pentraxin 3 (PTX3) and uromodulin
Time frame: 4 days
To determine the concentration of serum PTX3 and serum uromodulin in critically ill septic patients and their comparison to serum concentrations of creatinine and the acute kidney injury (AKI) stage as well as to the concentrations of procalcitonin (PCT) and interleukin-6 (IL-6) as inflammation markers on day 1 and 4 of study. The serum concentrations of PTX3 and uromodulin in ng/mL will be determined also in healthy volunteers to establish the laboratory reference ranges (values).
Determination of expression and 4 days course investigation of miRNAs
Time frame: 4 days
To determine the expression and 4-day time course investigation of 7 specific circulating miRNAs associated with sepsis and septic acute kidney injury from 352 miRNA targets using a two-tailed Quantitative reverse transcription polymerase chain reaction (RT-qPCR). All selected miRNAs will be determined also in healthy volunteers to establish the laboratory reference ranges (values).
Target genes of miRNAs and their association with endothelial dysfunction and mitochondrial injury in sepsis
Time frame: 4 days
To match the target genes (from miRNA database) of these specifically expressed miRNAs with biochemical pathways associated with serum PTX3 and uromodulin involved in endothelial dysfunction of renal microvasculature, the influence of mitochondrial injury/dysfunction with reactive oxygen species production and activation of cell apoptosis in septic acute kidney injury.
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 3 Jun 2026.
- Background: PubMed 26903338Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
- Background: PubMed 22895517Chen J, Matzuk MM, Zhou XJ, Lu CY. Endothelial pentraxin 3 contributes to murine ischemic acute kidney injury. Kidney Int. 2012 Dec;82(11):1195-207. doi: 10.1038/ki.2012.268. Epub 2012 Aug 15.
- Background: PubMed 29672566Lee HH, Kim SY, Na JC, Yoon YE, Han WK. Exogenous pentraxin-3 inhibits the reactive oxygen species-mitochondrial and apoptosis pathway in acute kidney injury. PLoS One. 2018 Apr 19;13(4):e0195758. doi: 10.1371/journal.pone.0195758. eCollection 2018.
- Background: PubMed 18495803El-Achkar TM, Wu XR, Rauchman M, McCracken R, Kiefer S, Dagher PC. Tamm-Horsfall protein protects the kidney from ischemic injury by decreasing inflammation and altering TLR4 expression. Am J Physiol Renal Physiol. 2008 Aug;295(2):F534-44. doi: 10.1152/ajprenal.00083.2008. Epub 2008 May 21.
- Background: PubMed 35759740LaFavers KA, Hage CA, Gaur V, Micanovic R, Hato T, Khan S, Winfree S, Doshi S, Moorthi RN, Twigg H, Wu XR, Dagher PC, Srour EF, El-Achkar TM. The kidney protects against sepsis by producing systemic uromodulin. Am J Physiol Renal Physiol. 2022 Aug 1;323(2):F212-F226. doi: 10.1152/ajprenal.00146.2022. Epub 2022 Jun 27.
- Background: PubMed 31578243LaFavers KA, Macedo E, Garimella PS, Lima C, Khan S, Myslinski J, McClintick J, Witzmann FA, Winfree S, Phillips CL, Hato T, Dagher PC, Wu XR, El-Achkar TM, Micanovic R. Circulating uromodulin inhibits systemic oxidative stress by inactivating the TRPM2 channel. Sci Transl Med. 2019 Oct 2;11(512):eaaw3639. doi: 10.1126/scitranslmed.aaw3639.
- Background: PubMed 38490803Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int. 2024 Apr;105(4S):S117-S314. doi: 10.1016/j.kint.2023.10.018. No abstract available.
- 2\. Kidney Disease Improving Global Outcomes (KDIGO) Acute Kidney Injury Work Group. KDIGO Clinical Practice Guideline for Acute Kidney Injury. Kidney inter., Suppl. 2012; 2: 1-138.Link provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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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.
Naděžda Petejová, Assoc.Prof.,MD,PhD,MSc principal investigator
University Hospital Ostrava
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Acute Kidney Injury, run by University Hospital Ostrava at 2 sites in Czechia.
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 7 inclusion and 7 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 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. 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?
Determination of serum expression of pentraxin 3 (PTX3) and uromodulin (time frame: 4 days). The study lists 3 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 NCT06498336, which also lists 7 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 3 Jun 2026.