Acute Kidney InjuryNCT07295392
Is There Any Prognostic Value of Serum Uromodulin in Sepsis Induced AKI.
An observational study of Acute Kidney Injury, run by Assiut University.
Trial summary
To determine whether baseline (day 0; day of diagnosis),day 7 and on discharge serum uromodulin levels help predict clinical outcomes in adult patients with sepsis induced AKI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2026to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: People who is recently diagnosed with AKI due to sepsis meeting the previously mentioned criteria and doesn't have the exclusion criteria.
Who may be able to join
- Age ≥ 18 years
- Septic patients with AKI: Diagnosis of sepsis is based on combination of variables including Sepsis-3 criteria within 24 hours of ICU admission(suspected or confirmed infection on clinical , lab and imaging evidence , acute increase in SOFA score =>2 points( or presence of septic shock). The latter is defined by a vasopressor requirement to maintain a mean arterial pressure of 65 mm Hg or greater and serum lactate level greater than 2 mmol/L (>18 mg/dL) in the absence of hypovolemia (Singer et al 2016).
- Diagnosis of AKI according to KDIGO-criteria ( increase creatinine by =>0.3 mg/dl ( =>26.5 micmol/l ) within 48 hrs or increase cr =>1.5 × baseline within 7days or urine output < 0.5 ml / kg / hr for => 6hrs)
- Informed consent obtained and in case patient is unable to sign the consent his next of kin or has power
Who cannot join
- Patients diagnosed with ESRD or kidney transplantation
- Other causes of AKI
- Pregnancy related causes of AKI
- Active immunosuppressive therapy (e.g., high-dose steroids, chemotherapy)
- Patients with background of adult polycystic kidney disease
- Patients with cardiac failure
- Patients with solitary kidney because of small renal mass that could affect uromodulin level.
About this study
Official title: Serum Uromodulin Prognostic Value in Sepsis Induced AKI
To determine whether baseline (day 0; day of diagnosis),day 7 and on discharge serum uromodulin levels help predict clinical outcomes in adult patients with sepsis induced AKI.
Read the detailed description
Sepsis remains a leading cause of morbidity and mortality worldwide, with risk rising as organs failure accumulate, particularly when acute kidney injury (AKI) develops. AKI complicates nearly half of all septic episodes in ICU and is independently associated with poorer short- and long-term outcomes. Current prognostic tools as SOFA score , serum creatinine, urine output, NGAL and KIM-1have limited prognostic value. They often detect injury only after significant damage has occurred.
Uromodulin, the most abundant urinary protein produced by the renal thick ascending limb, is present in small amounts in the circulation. Experimental models reveal that uromodulin deficiency worsens sepsis outcomes, while administration of exogenous uromodulin can reduce mortality . In clinical studies of septic patients, early rises in circulating uromodulin are observed, yet those who go on to develop AKI or die tend to have lower levels at presentation. Genetic analyses, however, have not definitively proven a causal protective role for baseline uromodulin.
It has roles in tubular protection, immune modulation, and infection control, These important physiological functions may translate into valuable prognostic tools that may aid in predicting clinical outcomes. Serum uromodulin may serve as an early indicator of both renal tubular integrity and host defence capacity-qualities not captured by existing markers. Assessing serum uromodulin at time of diagnosis(day 0), day 7 and at time of discharge may predict recovery or progression of AKI. Establishing the prognostic value of uromodulin could enable early risk stratification, guide tailored interventions, and inform clinical decision-making, potentially improving outcomes in sepsis-induced AKI.
- Conditions
- Acute Kidney Injury
- Keywords
- Serum uromodulin
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Uromodulin as a Predictor of Acute Kidney Injury Outcome in Septic Patients
To assess whether serum uromodulin levels measured at ICU admission (day 0), day 7, and at ICU discharge can predict AKI outcome (complete renal recovery versus progression to chronic kidney disease), length of ICU stay, and 30-day all-cause mortality in adult patients with sepsis-induced acute kidney injury.
Measured: 30 days
Secondary outcomes (1)
2.1.Correlation Between Serum Uromodulin Levels and Need for Renal Replacement Therapy. 2.2.Correlation Between Serum Uromodulin Levels and SOFA Score. 2.3.Correlation Between Serum Uromodulin Levels and AKI Severity.
Measured: From ICU admission to ICU discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start10 Mar 2026 (estimated)
- Primary completion10 Dec 2026 (estimated)
- Study completion30 Dec 2026 (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.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaymaa Ibrahim Mohammed Hassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295392
- Sponsor's protocol ID
- Uromodulin in AKI
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Uromodulin Prognostic Value in Sepsis Induced AKI
- ClinicalTrials.gov ID
- NCT07295392
- Acronym / sponsor ID
- Uromodulin in AKI
- Conditions
- Acute Kidney Injury
- Keywords
- Serum uromodulin
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Mar 2026 (estimated)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 19 Dec 2025 (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.
To determine whether baseline (day 0; day of diagnosis),day 7 and on discharge serum uromodulin levels help predict clinical outcomes in adult patients with sepsis induced AKI.
Detailed description
Sepsis remains a leading cause of morbidity and mortality worldwide, with risk rising as organs failure accumulate, particularly when acute kidney injury (AKI) develops. AKI complicates nearly half of all septic episodes in ICU and is independently associated with poorer short- and long-term outcomes. Current prognostic tools as SOFA score , serum creatinine, urine output, NGAL and KIM-1have limited prognostic value. They often detect injury only after significant damage has occurred.
Uromodulin, the most abundant urinary protein produced by the renal thick ascending limb, is present in small amounts in the circulation. Experimental models reveal that uromodulin deficiency worsens sepsis outcomes, while administration of exogenous uromodulin can reduce mortality . In clinical studies of septic patients, early rises in circulating uromodulin are observed, yet those who go on to develop AKI or die tend to have lower levels at presentation. Genetic analyses, however, have not definitively proven a causal protective role for baseline uromodulin.
It has roles in tubular protection, immune modulation, and infection control, These important physiological functions may translate into valuable prognostic tools that may aid in predicting clinical outcomes. Serum uromodulin may serve as an early indicator of both renal tubular integrity and host defence capacity-qualities not captured by existing markers. Assessing serum uromodulin at time of diagnosis(day 0), day 7 and at time of discharge may predict recovery or progression of AKI. Establishing the prognostic value of uromodulin could enable early risk stratification, guide tailored interventions, and inform clinical decision-making, potentially improving outcomes in sepsis-induced AKI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People who is recently diagnosed with AKI due to sepsis meeting the previously mentioned criteria and doesn't have the exclusion criteria.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Septic patients with AKI: Diagnosis of sepsis is based on combination of variables including Sepsis-3 criteria within 24 hours of ICU admission(suspected or confirmed infection on clinical , lab and imaging evidence , acute increase in SOFA score =>2 points( or presence of septic shock). The latter is defined by a vasopressor requirement to maintain a mean arterial pressure of 65 mm Hg or greater and serum lactate level greater than 2 mmol/L (>18 mg/dL) in the absence of hypovolemia (Singer et al 2016).
- Diagnosis of AKI according to KDIGO-criteria ( increase creatinine by =>0.3 mg/dl ( =>26.5 micmol/l ) within 48 hrs or increase cr =>1.5 × baseline within 7days or urine output < 0.5 ml / kg / hr for => 6hrs)
- Informed consent obtained and in case patient is unable to sign the consent his next of kin or has power
Key exclusion criteria (7 listed)
- Patients diagnosed with ESRD or kidney transplantation
- Other causes of AKI
- Pregnancy related causes of AKI
- Active immunosuppressive therapy (e.g., high-dose steroids, chemotherapy)
- Patients with background of adult polycystic kidney disease
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
Serum Uromodulin as a Predictor of Acute Kidney Injury Outcome in Septic Patients
Time frame: 30 days
To assess whether serum uromodulin levels measured at ICU admission (day 0), day 7, and at ICU discharge can predict AKI outcome (complete renal recovery versus progression to chronic kidney disease), length of ICU stay, and 30-day all-cause mortality in adult patients with sepsis-induced acute kidney injury.
1 secondary outcome
2.1.Correlation Between Serum Uromodulin Levels and Need for Renal Replacement Therapy. 2.2.Correlation Between Serum Uromodulin Levels and SOFA Score. 2.3.Correlation Between Serum Uromodulin Levels and AKI Severity.
Time frame: From ICU admission to ICU discharge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Assiut University.
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 4 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: opening soon, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Serum Uromodulin as a Predictor of Acute Kidney Injury Outcome in Septic Patients (time frame: 30 days). 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 31 Dec 2025.