Validity of Strain Elastography for the Evaluation of Chronic Allograft Nephropathy

NCT05682313 | Completed

• 1 other identifier: MD-53-2021
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Allograft Nephropathy

Keywords

Nephropathy, Chronic Tubulointerstitial; Kidney Transplantation; ultrasonography; Elasticity Imaging Techniques

Outcome Measures

Primary Outcomes (1)

• Grade of fibrosis

  degree of fibrosis obtained by elastography

  At the time of recruitment

Study Arms (1)

Elastography arm

EXPERIMENTAL

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

Diagnostic Test: Elastography arm

Interventions

Elastography arm DIAGNOSTIC_TEST

Renal ultrasound elastography to detect and classify the degree of fibrosis

Elastography arm

Eligibility Criteria

• Age: 14 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Cairo university hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Nephropathy, Chronic Tubulointerstitial

Study Officials

• Tarek Abdelaziz

  Kasr Alaini University Hsopitals

  PRINCIPAL INVESTIGATOR

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: Associate professor

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: January 12, 2023
• Study Start: January 7, 2021
• Primary Completion: July 13, 2022
• Study Completion: October 24, 2022
• Last Updated: January 12, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)