- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06623877
Using Renal Elastography Measurements for Evaluation of Glomerulonephritis Patients
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Assiut, Egypt, 2063045
- Faculty of medicine,Assiut universty,Egypy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
b. 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A: biopcy proven glomerulonephritis patients not started specific treatement
agroup of Biopcy proven glomerulonephritis patients not started specific treatement will undergo for renal shear wave elastography
|
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 |
|
Experimental: Group B : healthy persons
A group of healthy persons will undergo for renal shear wave elastography
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
comparisons between the shear wave elastography measurements in GN patients and healthy persons .
Time Frame: One year
|
One year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6121820722
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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