Chronic Allograft NephropathyNCT05682313
Validity of Strain Elastography for the Evaluation of Chronic Allograft Nephropathy
A study testing Elastography arm in people with Chronic Allograft Nephropathy, run by Kasr El Aini Hospital at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 14 to 55 years
- Conditions the study is for
- Chronic Allograft Nephropathy
- What is being tested?
- Elastography arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jan 2021to 24 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Conditions
- Chronic Allograft Nephropathy
- Being tested
- Elastography arm
- Keywords
- Nephropathy, Chronic Tubulointerstitial, Kidney Transplantation, ultrasonography, Elasticity Imaging Techniques
- Medical subject headings
- Nephropathy, Chronic Tubulointerstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastography armDiagnostic test
Renal ultrasound elastography to detect and classify the degree of fibrosis
| Study group | Role | What they receive |
|---|---|---|
| Elastography arm | Experimental | single arm that includes all patient who have consented for ultrasound elastography Receives: Diagnostic Test: Elastography arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade of fibrosis
degree of fibrosis obtained by elastography
Measured: At the time of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start7 Jan 2021
- Primary completion13 Jul 2022
- Study completion24 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Allograft NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Samy Abdelaziz, Kasr El Aini Hospital
- Investigators
- Tarek Abdelaziz, Principal investigator, Kasr Alaini University Hsopitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682313
- Sponsor's protocol ID
- MD-53-2021
- Status last verified
- Dec 2022
- First submitted
- 27 Dec 2022
- Last updated
- 12 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of Strain Elastography for the Evaluation of Chronic Allograft Nephropathy
- ClinicalTrials.gov ID
- NCT05682313
- Acronym / sponsor ID
- MD-53-2021
- Conditions
- Chronic Allograft Nephropathy
- Keywords
- Nephropathy, Chronic Tubulointerstitial, Kidney Transplantation, ultrasonography, Elasticity Imaging Techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 13 Jul 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elastography arm | Experimental | Diagnostic Test: Elastography armsingle arm that includes all patient who have consented for ultrasound elastography |
Who may qualify
- Ages
- 14 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elastography armRenal ultrasound elastography to detect and classify the degree of fibrosis | Diagnostic test | Elastography arm |
Primary outcome
Grade of fibrosis
Time frame: At the time of recruitment
degree of fibrosis obtained by elastography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarek Abdelaziz principal investigator
Kasr Alaini University Hsopitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elastography arm in people with Chronic Allograft Nephropathy, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade of fibrosis (time frame: At the time of recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.