NCT02830438

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2018

Completed
2 years until next milestone

Results Posted

Study results publicly available

June 5, 2020

Completed
Last Updated

June 5, 2020

Status Verified

May 1, 2020

Enrollment Period

1.9 years

First QC Date

July 7, 2016

Results QC Date

April 13, 2020

Last Update Submit

May 19, 2020

Conditions

Acute Kidney DiseaseChronic Kidney Disease

Keywords

kidney diseasefibrosisultrasoundelastography

Outcome Measures

Primary Outcomes (1)

  • Shear Wave Velocity of Kidney Parenchyma

    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).

    6 months

Study Arms (1)

Shear wave elastography group

EXPERIMENTAL

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

Device: Shear wave elastography

Interventions

Shear wave elastographyDEVICE

Ultrasound technique of the kidneys to assess wave elastography.

Shear wave elastography group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albert Einstein Healthcare Network

Philadelphia, Pennsylvania, 19141, United States

Location

Related Publications (3)

  • Hu Q, Wang XY, He HG, Wei HM, Kang LK, Qin GC. Acoustic radiation force impulse imaging for non-invasive assessment of renal histopathology in chronic kidney disease. PLoS One. 2014 Dec 29;9(12):e115051. doi: 10.1371/journal.pone.0115051. eCollection 2014.

    PMID: 25546304BACKGROUND

  • Samir AE, Allegretti AS, Zhu Q, Dhyani M, Anvari A, Sullivan DA, Trottier CA, Dougherty S, Williams WW, Babitt JL, Wenger J, Thadhani RI, Lin HY. Shear wave elastography in chronic kidney disease: a pilot experience in native kidneys. BMC Nephrol. 2015 Jul 31;16:119. doi: 10.1186/s12882-015-0120-7.

    PMID: 26227484RESULT

  • Lee J, Oh YT, Joo DJ, Ma BG, Lee AL, Lee JG, Song SH, Kim SU, Jung DC, Chung YE, Kim YS. Acoustic Radiation Force Impulse Measurement in Renal Transplantation: A Prospective, Longitudinal Study With Protocol Biopsies. Medicine (Baltimore). 2015 Sep;94(39):e1590. doi: 10.1097/MD.0000000000001590.

    PMID: 26426636RESULT

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney DiseasesFibrosis

Condition Hierarchy (Ancestors)

Renal InsufficiencyUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed due to technical problems during recruitment.

Results Point of Contact

Title
Mario Naranjo-Tovar
Organization
AlbertEHN
mario.edu6@hotmail.com
2157965542

Study Officials

  • Mario Naranjo-Tovar, MD

    Albert Einstein Healthcare Network

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 7, 2016

First Posted

July 12, 2016

Study Start

July 1, 2016

Primary Completion

June 10, 2018

Study Completion

June 10, 2018

Last Updated

June 5, 2020

Results First Posted

June 5, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)