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Validity of Strain Elastography for the Evaluation of Chronic Allograft Nephropathy

Primary Purpose

Chronic Allograft Nephropathy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Elastography arm
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Allograft Nephropathy focused on measuring Nephropathy, Chronic Tubulointerstitial, Kidney Transplantation, ultrasonography, Elasticity Imaging Techniques

Eligibility Criteria

14 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Renal transplant patients of more than 2 years duration, Chronic allograft nephropathy proved by renal biopsy done within 1 month from the date of the strain elastography, Body mass index less than 30 kg/m2, Skin allograft distance of less than 3.5 cm, Parenchyma thickness of more than 1 cm and no fluid accumulation around the allograft. Exclusion Criteria: Body mass index more than 30 kg/m2, Skin allograft distance more than 3.5 cm, Parenchymal thickness less than 1 cm, Presence of any fluid collection around the allograft, GFR less than 15 ml/min, Graft stones or backpressure and less than 14 years old or more than 55 years old.

Sites / Locations

  • Cairo university hospitals

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Elastography arm

Arm Description

single arm that includes all patient who have consented for ultrasound elastography

Outcomes

Primary Outcome Measures

Grade of fibrosis
degree of fibrosis obtained by elastography

Secondary Outcome Measures

Full Information

First Posted
December 27, 2022
Last Updated
December 27, 2022
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05682313
Brief Title
Validity of Strain Elastography for the Evaluation of Chronic Allograft Nephropathy
Official Title
Validity of Strain Elastography for the Evaluation of Chronic Allograft Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 7, 2021 (Actual)
Primary Completion Date
July 13, 2022 (Actual)
Study Completion Date
October 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Chronic allograft nephropathy is one of dreaded complication of kidney transplant. It is one of the major determinants of long term graft survival. There are a number of factors that can contribute to chronic allograft nephropathy including chronic use of calcineurin inhibitors. Renal biopsy is the investigation of choice to detect chronic renal allograft nephropathy. renal biopsy has a number of complications . This includes infection and bleeding. The non invasive renal sono-elastography (strain and Shear Wave Imaging) technique has shown very good yield of detecting and scoring fibrosis. In this study our aim is to determine the sensitivity and specificity of ( strain sono-elastography) in the detection and classifying of chronic allograft nephropathy as compared to transcutaneous renal biops
Detailed Description
Chronic allograft nephropathy is one of dreaded complication of kidney transplant. It is one of the major determinants of long term graft survival. There are a number of factors that can contribute to chronic allograft nephropathy including chronic use of calcineurin inhibitors. Renal biopsy is the investigation of choice to detect chronic renal allograft nephropathy. renal biopsy has a number of complications . This includes infection and bleeding. The non invasive renal sono-elastography (strain and Shear Wave Imaging) technique has shown very good yield of detecting and scoring fibrosis. In this study our aim is to determine the sensitivity and specificity of ( strain sono-elastography) in the detection and classifying of chronic allograft nephropathy as compared to transcutaneous renal biopsy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Allograft Nephropathy
Keywords
Nephropathy, Chronic Tubulointerstitial, Kidney Transplantation, ultrasonography, Elasticity Imaging Techniques

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elastography arm
Arm Type
Experimental
Arm Description
single arm that includes all patient who have consented for ultrasound elastography
Intervention Type
Diagnostic Test
Intervention Name(s)
Elastography arm
Intervention Description
Renal ultrasound elastography to detect and classify the degree of fibrosis
Primary Outcome Measure Information:
Title
Grade of fibrosis
Description
degree of fibrosis obtained by elastography
Time Frame
At the time of recruitment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Renal transplant patients of more than 2 years duration, Chronic allograft nephropathy proved by renal biopsy done within 1 month from the date of the strain elastography, Body mass index less than 30 kg/m2, Skin allograft distance of less than 3.5 cm, Parenchyma thickness of more than 1 cm and no fluid accumulation around the allograft. Exclusion Criteria: Body mass index more than 30 kg/m2, Skin allograft distance more than 3.5 cm, Parenchymal thickness less than 1 cm, Presence of any fluid collection around the allograft, GFR less than 15 ml/min, Graft stones or backpressure and less than 14 years old or more than 55 years old.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarek Abdelaziz
Organizational Affiliation
Kasr Alaini University Hsopitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo university hospitals
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Validity of Strain Elastography for the Evaluation of Chronic Allograft Nephropathy

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