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Shear Wave Elastography in Native Kidney Disease

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ClinicalTrials.gov Identifier: NCT02830438
Recruitment Status : Terminated (Not enough participants recruited)
First Posted : July 12, 2016
Results First Posted : June 5, 2020
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Mario Naranjo-Tovar, MD, Albert Einstein Healthcare Network

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Acute Kidney Disease
Chronic Kidney Disease
Intervention Device: Shear wave elastography
Enrollment 8
Recruitment Details Outpatient
Pre-assignment Details  
Arm/Group Title Shear Wave Elastography Group
Hide Arm/Group Description

Patients referred for kidney biopsy will then undergo shear wave elastography measurements.

Shear wave elastography: Ultrasound technique of the kidneys to assess wave elastography.

Period Title: Overall Study
Started 8
Completed 8
Not Completed 0
Arm/Group Title Shear Wave Elastography Group
Hide Arm/Group Description

Patients referred for kidney biopsy will then undergo shear wave elastography measurements.

Shear wave elastography: Ultrasound technique of the kidneys to assess wave elastography.

Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
  62.5%
>=65 years
3
  37.5%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 8 participants
52.1
(33 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
4
  50.0%
Male
4
  50.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
African American
3
  37.5%
Caucasian
2
  25.0%
Hispanic/Latino
3
  37.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
 100.0%
1.Primary Outcome
Title Shear Wave Velocity of Kidney Parenchyma
Hide Description The shear wave velocity of the kidneys will be determined using the elastography ultrasound machine. This will enable us to calculate the tissue elasticity using a standard formula. Shear wave velocity is measured in meters per second, at a range of 0-5 m/s with the highest number reporting hard consistency (fibrosis - worse outcome).
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Shear Wave Elastography Group
Hide Arm/Group Description:

Patients referred for kidney biopsy will then undergo shear wave elastography measurements.

Shear wave elastography: Ultrasound technique of the kidneys to assess wave elastography.

Overall Number of Participants Analyzed 8
Median (Standard Deviation)
Unit of Measure: meters per second
0.21  (0.71)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Shear Wave Elastography Group
Hide Arm/Group Description

Patients referred for kidney biopsy will then undergo shear wave elastography measurements.

Shear wave elastography: Ultrasound technique of the kidneys to assess wave elastography.

All-Cause Mortality
Shear Wave Elastography Group
Affected / at Risk (%)
Total   0/8 (0.00%) 
Hide Serious Adverse Events
Shear Wave Elastography Group
Affected / at Risk (%)
Total   0/8 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Shear Wave Elastography Group
Affected / at Risk (%)
Total   0/8 (0.00%) 
Early termination leading to small numbers of subjects analyzed due to technical problems during recruitment.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mario Naranjo-Tovar
Organization: AlbertEHN
Phone: 2157965542
EMail: mario.edu6@hotmail.com
Layout table for additonal information
Responsible Party: Mario Naranjo-Tovar, MD, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT02830438    
Other Study ID Numbers: 4837
8574 ( Other Grant/Funding Number: Albert Einstein Society Grant )
First Submitted: July 7, 2016
First Posted: July 12, 2016
Results First Submitted: April 13, 2020
Results First Posted: June 5, 2020
Last Update Posted: June 5, 2020