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Shear Wave Elastography in Native Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 7, 2016
First Posted Date  ICMJE July 12, 2016
Results First Submitted Date  ICMJE April 13, 2020
Results First Posted Date  ICMJE June 5, 2020
Last Update Posted Date June 5, 2020
Actual Study Start Date  ICMJE July 1, 2016
Actual Primary Completion Date June 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2020)
Shear Wave Velocity of Kidney Parenchyma [ Time Frame: 6 months ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: July 8, 2016)
Shear Wave Velocity of Kidney Parenchyma [ Time Frame: 6 months ]
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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Shear Wave Elastography in Native Kidney Disease
Official Title  ICMJE Shear Wave Elastography in Native Kidney Disease: a Pilot Study
Brief Summary

In this proposal, the aim is to examine shear wave elastography (SWE) measurements in diseased native kidneys and correlate them with grades of fibrosis using histological samples.

The overall goals of the proposed study are addressed by the following specific aim.

Specific aim: To determine whether differences exist in elasticity measurements between native kidneys with and without fibrosis.

Hypothesis: Kidneys with higher grades of fibrosis will demonstrate higher measures of tissue elasticity and stiffness compared to kidneys with zero fibrosis.

Detailed Description

The proposed project is a prospective cross-sectional study correlating native kidney shear wave elastography (SWE) measurements with histology. Briefly, patients referred for a native kidney biopsy will undergo SWE and the shear wave velocity (SWV) will be correlated with degree of fibrosis determined by a pathologist.

A list of patients who recently underwent a native kidney biopsy will be obtained from the pathology department on a weekly basis. Patients will then be contacted about participating in the study and consented during a follow up visit with their nephrologist.

After their biopsies, patients will be scheduled to come for a renal ultrasound and SWE. SWE examination will be conducted using an ultrasound machine equipped with a Philips Epiq ARFI Shear wave ElastPQ C1-5 mHz transducer. Shear wave velocity will be obtained and an estimate of tissue elasticity (Young's modulus) will be calculated. All measurements will be performed by one of two qualified radiology physicians who will be blinded to the clinical and pathological data. We will allow a period of 90 days to obtain the images after the biopsy; otherwise the patient is no longer eligible to participate.

The primary outcome measure of this study is to determine whether tissue elasticity determined by SWE can assess kidney fibrosis. Linear regression analysis will be performed to describe the relation of the extent of fibrosis and parenchymal stiffness.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Acute Kidney Disease
  • Chronic Kidney Disease
Intervention  ICMJE Device: Shear wave elastography
Ultrasound technique of the kidneys to assess wave elastography.
Study Arms  ICMJE Experimental: Shear wave elastography group
Patients referred for kidney biopsy will then undergo shear wave elastography measurements.
Intervention: Device: Shear wave elastography
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 19, 2020)
8
Original Estimated Enrollment  ICMJE
 (submitted: July 8, 2016)
40
Actual Study Completion Date  ICMJE June 10, 2018
Actual Primary Completion Date June 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients over 18 years of age who are referred for a native kidney biopsy.

Exclusion Criteria:

  • BMI > 35
  • Patients with polycystic kidney disease, renal cell carcinoma, hydronephrosis or renal stones.
  • Patients who develop severe post biopsy complications (infection, significant bleeding requiring transfusion or intervention)
  • Pregnant patients.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02830438
Other Study ID Numbers  ICMJE 4837
8574 ( Other Grant/Funding Number: Albert Einstein Society Grant )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mario Naranjo-Tovar, MD, Albert Einstein Healthcare Network
Study Sponsor  ICMJE Albert Einstein Healthcare Network
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mario Naranjo-Tovar, MD Albert Einstein Healthcare Network
PRS Account Albert Einstein Healthcare Network
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP