Evaluation of Biopcy Proven Glomerulonephritis Patients by Renal Shear Wave ElastographyNCT06623877
Using Renal Elastography Measurements for Evaluation of Glomerulonephritis Patients
A study testing renal shear wave elastography in people with Evaluation of Biopcy Proven Glomerulonephritis Patients by Renal Shear Wave Elastography, run by Assiut University at 1 site in Egypt.
Trial summary
All participants will clinically evaluated by history taking, full physical examination including body weight and assessment of fluid status, and blood and urine samples for lab analysis (serum creatinine, urea, sodium, potassium, corrected calcium, phosphorous, estimated glomerular filtration rate(GFR) by Cokcroft… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Evaluation of Biopcy Proven Glomerulonephritis Patients by Renal Shear Wave Elastography
- What is being tested?
- renal shear wave elastography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 Nov 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
a-inclusion criteria :
- adult patients aged 18 years old or more
- patients diagnosed as glomerulonephritis ( biopcy proven ) and not started specific tratement in Assiut University Hospitals
- Exclusion criteria:
- patient with urinary tract obstruction
- patient who has GN and started corticosteroid and/or immunosuppressive drugs
- patient who has congenital anomalies in renal system
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of medicine,Assiut universty,Egypy
Asyut, Asyut Governorate, 2063045
About this study
All participants will clinically evaluated by history taking, full physical examination including body weight and assessment of fluid status, and blood and urine samples for lab analysis (serum creatinine, urea, sodium, potassium, corrected calcium, phosphorous, estimated glomerular filtration rate(GFR) by Cokcroft equation ((140 - age ) x body weight by Kg/creatinine by µmol )complete urine analysis including microscopic examination of urine , 24 hours urinary protein , haemoglobin level .
All participants will undergo renal shear wave elastography measurements. Values will be obtained from the upper, middle, and lower zones of each kidney. A total of six shear wave elastography measurements will be collected to get mean elastography values (MEVs) of each participant.
Read the detailed description
We will collect results of MEV plus blood and urine samples of each participant then data will undergo statistical analysis to compare between MEV of healthy persons and biopcy proven glomerulonephritis patients
- Being tested
- renal shear wave elastography
- Keywords
- elastography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal shear wave elastographyDiagnostic test
Renal shear wave elastography is a non-invasive ultrasound elastography technique that allows measurements of tissue stiffness. It provides real-time measurements of shear wave velocity (SWV) generated with an acoustic impulse, thereby providing quantitative information about tissue elasticity. Harder tissues have been shown to have higher SWV .
Renal shear wave elastography will be done to both groups
| Study group | Role | What they receive |
|---|---|---|
| Group A: biopcy proven glomerulonephritis patients not started specific treatement | Experimental | agroup of Biopcy proven glomerulonephritis patients not started specific treatement will undergo for renal shear wave elastography Receives: Diagnostic Test: renal shear wave elastography |
| Group B : healthy persons | Experimental | A group of healthy persons will undergo for renal shear wave elastography Receives: Diagnostic Test: renal shear wave elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparisons between the shear wave elastography measurements in GN patients and healthy persons .
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluation of Biopcy Proven Glomerulonephritis Patients by Renal Shear Wave ElastographyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmes Essam Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623877
- Sponsor's protocol ID
- 6121820722
- Status last verified
- Sep 2024
- First submitted
- 24 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Renal Elastography Measurements for Evaluation of Glomerulonephritis Patients
- ClinicalTrials.gov ID
- NCT06623877
- Acronym / sponsor ID
- 6121820722
- Keywords
- elastography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 2 Oct 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.
All participants will clinically evaluated by history taking, full physical examination including body weight and assessment of fluid status, and blood and urine samples for lab analysis (serum creatinine, urea, sodium, potassium, corrected calcium, phosphorous, estimated glomerular filtration rate(GFR) by Cokcroft equation ((140 - age ) x body weight by Kg/creatinine by µmol )complete urine analysis including microscopic examination of urine , 24 hours urinary protein , haemoglobin level .
All participants will undergo renal shear wave elastography measurements. Values will be obtained from the upper, middle, and lower zones of each kidney. A total of six shear wave elastography measurements will be collected to get mean elastography values (MEVs) of each participant.
Detailed description
We will collect results of MEV plus blood and urine samples of each participant then data will undergo statistical analysis to compare between MEV of healthy persons and biopcy proven glomerulonephritis patients
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: biopcy proven glomerulonephritis patients not started specific treatement | Experimental | Diagnostic Test: renal shear wave elastographyagroup of Biopcy proven glomerulonephritis patients not started specific treatement will undergo for renal shear wave elastography |
| Group B : healthy persons | Experimental | Diagnostic Test: renal shear wave elastographyA group of healthy persons will undergo for renal shear wave elastography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 shear wave elastographyRenal shear wave elastography is a non-invasive ultrasound elastography technique that allows measurements of tissue stiffness. It provides real-time measurements of shear wave velocity (SWV) generated with an acoustic impulse, thereby providing quantitative information about tissue elasticity. Harder tissues have been shown to have higher SWV . Renal shear wave elastography will be done to both groups | Diagnostic test | Group A: biopcy proven glomerulonephritis patients not started specific treatement, Group B : healthy persons |
Primary outcome
comparisons between the shear wave elastography measurements in GN patients and healthy persons .
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 shear wave elastography in people with Evaluation of Biopcy Proven Glomerulonephritis Patients by Renal Shear Wave Elastography, run by Assiut 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?
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 2 Oct 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?
Results are not available in the source record.
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?
comparisons between the shear wave elastography measurements in GN patients and healthy persons . (time frame: One year). 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 2 Oct 2024.