Renal FailureNCT04423458
Evaluation of Advanced US Tools in Assessing Allograft Complications
An observational study of Renal Failure and Chronic Kidney Diseases, run by Imperial College London at 1 site in United Kingdom.
Trial summary
This study evaluates the role of advanced US technology in assessing renal transplants as screening tools such as 3D Ultrasound, Ultrasound SWE, and MFI besides current ultrasound conventional metheds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure, Chronic Kidney Diseases, Failure,Kidney
- What is being tested?
- 3D imaging
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jan 2022to 30 Sep 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients having /had kindey transplant
Who may be able to join
- Patients ≥ 18 years.
- Tx patients.
- Gender.
Who cannot join
- Prisoners.
- Patients < 18 years.
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Evaluation of Advanced Ultrasonography Applications in the Assessment of Transplanted Kidney Complications
This study evaluates the role of advanced US technology in assessing renal transplants as screening tools such as 3D Ultrasound, Ultrasound SWE, and MFI besides current ultrasound conventional metheds.
Read the detailed description
This study will focus on monitoring renal after transplantation using all US advanced technology.
Aim one will concentrate on the 3D US in assessing artery stenosis (TRAS) compared to the gold standard.
Aim two focuses on will concentrate on Ultrasound elastography in assessing renal stiffness.
Aim three will compare US colour modes such as PD, CD and MFI to assess renal perfusion in three groups.
Duration: 18 Months; participants will have a patient information sheet; once they are happy to participate, consent will be obtained.
Study data will be entered into a database encrypted and stored in the department. Only the study principal investigator (PI) will know the study database password.
- Conditions
- Renal Failure, Chronic Kidney Diseases, Failure,Kidney, Renal Artery Stenosis, Fibrosis, Complications
- Being tested
- 3D imaging
- Keywords
- 3D Ultrasound, US elastography, US MFI, Ultrasound, MRI, CT
- Medical subject headings
- Renal Insufficiency, Renal Insufficiency, Chronic, Renal Artery Obstruction, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D imagingDevice
The study will focus on the accuracy of ultrasound technology in assessing renal transplants.
The entire assessment should not take more than 25 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Transplanted kidney | No intervention is required. Routine Doppler assessment + 3D scan + Shear wave elastography + MicrFlow Imaging will be immediately recorded afterwards Receives: Device: 3D imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak systolic velocity (cm/s).
Pean of the blood flow velocities in the artery/ vein peak systolic velocity ≥200 cm/s velocity difference between pre- and post-stenotic segments of 2:1
Measured: 12 weeks
Peak systolic velocity ratio (PSVR).
High velocity flow at the stenosis site divided by a reference velocity (normal before stenosis)
Measured: 12 weeks
Resistive Index (RI).
An RI less than 0.7 to 0.8 is considered normal, more than that it is indicator of transplant dysfunction.
Measured: 12 weeks
Secondary outcomes (2)
Volumetric stenosis.
Plaque volume is calculated automatically with the aid of software with a package of 3D laptop.
Measured: 12 weeks
3D GSM.
Plaque volume is calculated automatically with the aid of software with a package of 3D laptop.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start4 Jan 2022
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammed Aslam, PhD, Study director, Academic Supervisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423458
- Sponsor's protocol ID
- 848 -20HH6053
- Status last verified
- Feb 2023
- First submitted
- 5 Jun 2020
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Advanced Ultrasonography Applications in the Assessment of Transplanted Kidney Complications
- ClinicalTrials.gov ID
- NCT04423458
- Acronym / sponsor ID
- 848 -20HH6053
- Conditions
- Renal Failure, Chronic Kidney Diseases, Failure,Kidney, Renal Artery Stenosis, Fibrosis, Complications
- Keywords
- 3D Ultrasound, US elastography, US MFI, Ultrasound, MRI, CT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 9 Jun 2020 (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.
This study evaluates the role of advanced US technology in assessing renal transplants as screening tools such as 3D Ultrasound, Ultrasound SWE, and MFI besides current ultrasound conventional metheds.
Detailed description
This study will focus on monitoring renal after transplantation using all US advanced technology.
Aim one will concentrate on the 3D US in assessing artery stenosis (TRAS) compared to the gold standard.
Aim two focuses on will concentrate on Ultrasound elastography in assessing renal stiffness.
Aim three will compare US colour modes such as PD, CD and MFI to assess renal perfusion in three groups.
Duration: 18 Months; participants will have a patient information sheet; once they are happy to participate, consent will be obtained.
Study data will be entered into a database encrypted and stored in the department. Only the study principal investigator (PI) will know the study database password.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transplanted kidney | – | Device: 3D imagingNo intervention is required. Routine Doppler assessment + 3D scan + Shear wave elastography + MicrFlow Imaging will be immediately recorded afterwards |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients having /had kindey transplant
Key inclusion criteria (3 listed)
- Patients ≥ 18 years.
- Tx patients.
- Gender.
Key exclusion criteria (3 listed)
- Prisoners.
- Patients < 18 years.
- Pregnant women
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 |
|---|---|---|
| 3D imagingThe study will focus on the accuracy of ultrasound technology in assessing renal transplants. The entire assessment should not take more than 25 minutes. | Device | Transplanted kidney |
Primary outcome
Peak systolic velocity (cm/s).
Time frame: 12 weeks
Pean of the blood flow velocities in the artery/ vein peak systolic velocity ≥200 cm/s velocity difference between pre- and post-stenotic segments of 2:1
Peak systolic velocity ratio (PSVR).
Time frame: 12 weeks
High velocity flow at the stenosis site divided by a reference velocity (normal before stenosis)
Resistive Index (RI).
Time frame: 12 weeks
An RI less than 0.7 to 0.8 is considered normal, more than that it is indicator of transplant dysfunction.
2 secondary outcomes
Volumetric stenosis.
Time frame: 12 weeks
3D GSM.
Time frame: 12 weeks
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 8 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Renal Failure
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Mohammed Aslam, PhD study director
Academic Supervisor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Failure and Chronic Kidney Diseases, run by Imperial College London at 1 site in United Kingdom.
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 3 inclusion and 3 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 8 Feb 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 United Kingdom. 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?
Peak systolic velocity (cm/s). (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 8 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.