Urinary Activin A in AKINCT06188533
Urinary Activin A as Apredictive Marker for Assessement of Acute Kidney Injury Severity in Patient Admitted at Assuit University Hospital
An observational study of Urinary Activin A in AKI, run by Assiut University.
Trial summary
Urinary Activin A as amarker for assessement of acute kidney injury severity in patient admitted at Assuit University Hospital Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Urinary Activin A in AKI
- What is being tested?
- Urinary activin A in AKI
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 5 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 to 99 years
- All sexes
- Adult, Older adult
Study population: * level of Activin A in urine correlate to the severity of the acute kidney injury (AKI), as the level of urinary Activin A in first stages of acute kidney injury is less than the second and third stages . (4) * so follow up of urinary Activin A in patients with acute kidney injury can be avery useful biomarker for assessement of severity of acute kidney injury
Who may be able to join
- The study will include patient with acute kidney injury with no history of chronic kidney diseases
Who cannot join
- patient with history of chronic kidney diseases , diseases associated with icreased activin A level such as ( heart failure , cancers , COPD , systemic sclerosis ,pregnant , viral infection , and Mycosis Fungoides and Sézary Syndrom
About this study
Urinary Activin A as amarker for assessement of acute kidney injury severity in patient admitted at Assuit University Hospital
Read the detailed description
Acute kidney injury has been ahealth problem all over the world , It's prevelance in developing and developed countries is increasing due to pre renal , renal , post renal causes .
Estimates of AKI prevalence range from <1% to 66%. These variations can be explained by not only population differences but also inconsistent use of standardized AKI classification criteria. The aetiology and incidence of AKI also differ between high-income and low-to-middle-income countries.(1)
- It can be presented in different stages according to AKIN classification (stage l (Increase in serum creatinine ≥0.3md/dl (≥26.4μmol/l) or increase to >150% to 200% (1.5 fold to 2 fold) from baseline , and urine output (<0.5 ml/kg/h for >6 h ))
- stage ll (Increase to >200% to 300% (>2 fold to 3 fold) from baseline) , and urine output (<0.5 ml/kg/h for >12 h ))
- stage lll(Increase in serum creatinine to >300% (>3 fold) from baseline, or serum creatinine >4.0mg/dl (>354μmol/l) with acute increase of atleast 0.5mg/dl ) Urine output(<0.3ml/kg/hr for 24 hours, or anuria for 12 hours). (2)
- In ischemic kidney, there is acytokine belong to the transforming growth factor (TGF)-B ( Activin A) that regulates the growth and differantiation of cell in variuos organs was significantly increasd in ischemic kidney . (3)
- level of Activin A in urine correlate to the severity of the acute kidney injury (AKI), as the level of urinary Activin A in first stages of acute kidney injury is less than the second and third stages . (4)
- so follow up of urinary Activin A in patients with acute kidney injury can be avery useful biomarker for assessement of severity of acute kidney injury. (4)
- Conditions
- Urinary Activin A in AKI
- Being tested
- Urinary activin A in AKI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary activin A in AKIOther
Urinary activin A in AKI patient
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary activin A in AKI
To correlate between Activin A level in urine and severity of AKI
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Mar 2024 (estimated)
- Primary completion5 Jan 2026 (estimated)
- Study completion5 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Activin A in AKIStudies 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
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamal mahmoud mohamed amin, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188533
- Sponsor's protocol ID
- Urinary activin A in AKI
- Status last verified
- Feb 2024
- First submitted
- 19 Dec 2023
- Last updated
- 28 Feb 2024
- 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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Activin A as Apredictive Marker for Assessement of Acute Kidney Injury Severity in Patient Admitted at Assuit University Hospital
- ClinicalTrials.gov ID
- NCT06188533
- Acronym / sponsor ID
- Urinary activin A in AKI
- Conditions
- Urinary Activin A in AKI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 5 Jan 2026 (estimated)
- Study completion
- 5 Dec 2026 (estimated)
- First posted
- 3 Jan 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.
Urinary Activin A as amarker for assessement of acute kidney injury severity in patient admitted at Assuit University Hospital
Detailed description
Acute kidney injury has been ahealth problem all over the world , It's prevelance in developing and developed countries is increasing due to pre renal , renal , post renal causes .
Estimates of AKI prevalence range from <1% to 66%. These variations can be explained by not only population differences but also inconsistent use of standardized AKI classification criteria. The aetiology and incidence of AKI also differ between high-income and low-to-middle-income countries.(1)
- It can be presented in different stages according to AKIN classification (stage l (Increase in serum creatinine ≥0.3md/dl (≥26.4μmol/l) or increase to >150% to 200% (1.5 fold to 2 fold) from baseline , and urine output (<0.5 ml/kg/h for >6 h ))
- stage ll (Increase to >200% to 300% (>2 fold to 3 fold) from baseline) , and urine output (<0.5 ml/kg/h for >12 h ))
- stage lll(Increase in serum creatinine to >300% (>3 fold) from baseline, or serum creatinine >4.0mg/dl (>354μmol/l) with acute increase of atleast 0.5mg/dl ) Urine output(<0.3ml/kg/hr for 24 hours, or anuria for 12 hours). (2)
- In ischemic kidney, there is acytokine belong to the transforming growth factor (TGF)-B ( Activin A) that regulates the growth and differantiation of cell in variuos organs was significantly increasd in ischemic kidney . (3)
- level of Activin A in urine correlate to the severity of the acute kidney injury (AKI), as the level of urinary Activin A in first stages of acute kidney injury is less than the second and third stages . (4)
- so follow up of urinary Activin A in patients with acute kidney injury can be avery useful biomarker for assessement of severity of acute kidney injury. (4)
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- * level of Activin A in urine correlate to the severity of the acute kidney injury (AKI), as the level of urinary Activin A in first stages of acute kidney injury is less than the second and third stages . (4) * so follow up of urinary Activin A in patients with acute kidney injury can be avery useful biomarker for assessement of severity of acute kidney injury
Key inclusion criteria (1 listed)
- The study will include patient with acute kidney injury with no history of chronic kidney diseases
Key exclusion criteria (1 listed)
- patient with history of chronic kidney diseases , diseases associated with icreased activin A level such as ( heart failure , cancers , COPD , systemic sclerosis ,pregnant , viral infection , and Mycosis Fungoides and Sézary Syndrom
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 |
|---|---|---|
| Urinary activin A in AKIUrinary activin A in AKI patient | Other | – |
Primary outcome
Urinary activin A in AKI
Time frame: Baseline
To correlate between Activin A level in urine and severity of AKI
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 28 Feb 2024.
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 Urinary Activin A in AKI, 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 1 inclusion and 1 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 28 Feb 2024. 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?
Urinary activin A in AKI (time frame: Baseline). 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 28 Feb 2024.