Validity of Strain Elastography for the Evaluation of Chronic Allograft Nephropathy

Chronic Allograft Nephropathy Clinical Trial

Official title:

Validity of Strain Elastography for the Evaluation of Chronic Allograft Nephropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05682313
• Other study ID #: MD-53-2021
• Status: Completed
• Phase: N/A
• Start date: January 7, 2021
• Est. completion date: October 24, 2022

Study information

• Verified date: December 2022
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: October 24, 2022
• Est. primary completion date: July 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Allograft Nephropathy
• Kidney Diseases

Intervention

Diagnostic Test:
• Elastography arm
Renal ultrasound elastography to detect and classify the degree of fibrosis

Locations

Country	Name	City	State
Egypt	Cairo university hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grade of fibrosis	degree of fibrosis obtained by elastography	At the time of recruitment