Diagnostic ImagingNCT04044404
Application of Ultrasound Integrated Precision Diagnosis Technology in Prevention of Kidney Disease and Its Progress
An observational study of Diagnostic Imaging and Diagnosis, run by RenJi Hospital at 2 sites in China.
Trial summary
In this study, a prospective, randomized and controlled clinical study would be carried out to establish Ultrasound Integrated Precision Diagnosis Technology with elastography as the core technology to evaluate renal injury and repair comprehensively and accurately, and to improve the clinical diagnosis chance of… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diagnostic Imaging, Diagnosis, Kidney Disease
- What is being tested?
- Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography)
- How many people
- 208 participants
- Where
- 2 sitesChina
- Study dates
- 29 Apr 2019to 30 Jun 2021
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: For A on C group:18-70 years old patient who can cooperate with breath-holding, breath-holding and breath-exhaling movements, and communicate without obstacles, signed informed consent and with abnormal renal pathology or glomerular filtration rate(GFR) (15 <GFR<90 ml/min.1.73 m2) or proteinuria > 1 g/24 h due to any cause. For fDGF in kidney transplantation patient :18-65 years old patient who can cooperate with breath-holding, breath-holding and breath-exhaling movements, and communicate without obstacles, signed informed consent and received Kidney transplant recipients in our hospital from May 2019 to November 2019.
Who may be able to join
- for A on C group 1.18-70 years old; gender is not limited; 2. Patients who can cooperate with breath-holding, breath-holding and breath-exhaling movements, and communicate without obstacles.
- 3.The informed consent has been signed; 4.Abnormal renal pathology or glomerular filtration rate(GFR) (15 <GFR<90 ml/min.1.73 m2) or proteinuria > 1 g/24 h due to any cause.
- for kidney transplantation
- 18-70 years old; gender is not limited;
- It can cooperate with breath-holding, breath-holding and breath-exhaling movements, and communicate without obstacles.
- The informed consent has been signed;
- Kidney transplant recipients in our hospital from May 2019 to November 2019
Who cannot join
- for A on C group
- Can't cooperate, can't lie down for at least 10 minutes, unconsciousness, severe hypoxia, restlessness need to rescue patients.
- Patients with pregnancy or cancer;
- There are other serious diseases that the researchers do not think it is suitable to participate in this experiment.
- Absolute contraindications of renal puncture, ① Obvious bleeding tendency; ②Severe hypertension (systolic pressure greater than 180 mm Hg or diastolic pressure greater than 115 mm Hg); ③Psychiatric patients or non-cooperating operators and isolated kidney (small kidney) Or relative contraindications of renal puncture: ① Active pyelonephritis, renal tuberculosis, hydronephrosis or pyonephrosis, ②renal abscess or perirenal abscess. ③Renal tumors or renal aneurysms. ④Polycystic kidney or renal cyst. ⑤Kidney position is too high (deep inhalation of the lower pole of the kidney is not below the twelve ribs) or migratory kidney. ⑥Obesity, severe ascites.
- b）for kidney transplantation
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- Can't cooperate, can't lie down for at least 10 minutes, unconsciousness, severe hypoxia, restlessness need to rescue patients.
- Patients with pregnancy or cancer;
- There are other serious diseases that the researchers do not think it is suitable to participate in this experiment.
- Absolute contraindications of renal puncture, ① Obvious bleeding tendency; ②Severe hypertension (systolic pressure greater than 180 mm Hg or diastolic pressure greater than 115 mm Hg); ③Psychiatric patients or non-cooperating operators and isolated kidney (small kidney) Or relative contraindications of renal puncture: ① Active pyelonephritis, renal tuberculosis, hydronephrosis or pyonephrosis, ②renal abscess or perirenal abscess. ③Renal tumors or renal aneurysms. ④Polycystic kidney or renal cyst. ⑤Kidney position is too high (deep inhalation of the lower pole of the kidney is not below the twelve ribs) or migratory kidney. ⑥Obesity, severe ascites.
Trial locations and contacts
2 sites in 1 country.
China2 sites
China-Japan Friendship Hospital
Beijing
Department of nephrology , Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
About this study
In this study, a prospective, randomized and controlled clinical study would be carried out to establish Ultrasound Integrated Precision Diagnosis Technology with elastography as the core technology to evaluate renal injury and repair comprehensively and accurately, and to improve the clinical diagnosis chance of renal injury (or renal fibrosis).
Combined with the dynamic changes of biomarkers (inflammatory factors, cytokines secreted by immune cells, etc.) after kidney injury, the research on the prognosis of kidney disease with ultrasound elastography technology as the core would be explored, which aims to provide a scientific basis for the application of Ultrasound Integrated Precision Diagnosis Technology.
- Conditions
- Diagnostic Imaging, Diagnosis, Kidney Disease
- Being tested
- Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography)
- Keywords
- Ultrasound Elastography, Ultrasound Integrated Precision Diagnosis Technology, Acute on Chronic Kidney Disease, Kidney transplantation, kidney fibrosis
- Medical subject headings
- Disease, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography)Diagnostic test
Compare the ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography) with the diagnostic gold standard of kidney disease---kidney biopsy
| Study group | Role | What they receive |
|---|---|---|
| A on C group | Acute on Chronic Kidney Disease patients Receives: Diagnostic Test: Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography) | |
| functional delayed graft function group | patients with functional delayed graft function(fDGF) after kidney transplantation Receives: Diagnostic Test: Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography) | |
| Normal | without functional kidney injury Receives: Diagnostic Test: Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with creatinine increasing by more than 50%
Number of patients with creatinine increasing by more than 50% of baseline.
Measured: 1st month-12 month
Number of patients with initiation of continuous renal replacement therapy
for non-transplantation patient
Measured: 1st month-12 month
Rate of death
for all patients
Measured: 1st month-12 month
Secondary outcomes (3)
Number of patients with cardiovascular events
(acute myocardial infarction, unstable angina pectoris, heart failure requiring hospitalization or death from cardiovascular diseases);
Measured: 1st month-12 month
Number of patients with cerebrovascular events
(cerebral hemorrhage, subarachnoid hemorrhage, ischemic stroke, transient ischemic attack or death from cerebrovascular diseases);
Measured: 1st month-12 month
Number of patients with new serious infections requiring hospitalization
for all kidney injury
Measured: 1st month-12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start29 Apr 2019
- Primary completion29 May 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnostic ImagingStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Duke University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044404
- Sponsor's protocol ID
- RJ2018049
- Other IDs
- 2019-52-K33
- Status last verified
- Nov 2023
- First submitted
- 1 Aug 2019
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Ultrasound Integrated Precision Diagnosis Technology in Prevention of Kidney Disease and Its Progress
- ClinicalTrials.gov ID
- NCT04044404
- Acronym / sponsor ID
- RJ2018049
- Conditions
- Diagnostic Imaging, Diagnosis, Kidney Disease
- Keywords
- Ultrasound Elastography, Ultrasound Integrated Precision Diagnosis Technology, Acute on Chronic Kidney Disease, Kidney transplantation, kidney fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Duke University
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 29 May 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 5 Aug 2019 (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.
In this study, a prospective, randomized and controlled clinical study would be carried out to establish Ultrasound Integrated Precision Diagnosis Technology with elastography as the core technology to evaluate renal injury and repair comprehensively and accurately, and to improve the clinical diagnosis chance of renal injury (or renal fibrosis).
Combined with the dynamic changes of biomarkers (inflammatory factors, cytokines secreted by immune cells, etc.) after kidney injury, the research on the prognosis of kidney disease with ultrasound elastography technology as the core would be explored, which aims to provide a scientific basis for the application of Ultrasound Integrated Precision Diagnosis Technology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A on C group | – | Diagnostic Test: Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography)Acute on Chronic Kidney Disease patients |
| functional delayed graft function group | – | Diagnostic Test: Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography)patients with functional delayed graft function(fDGF) after kidney transplantation |
| Normal | – | Diagnostic Test: Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography)without functional kidney injury |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For A on C group:18-70 years old patient who can cooperate with breath-holding, breath-holding and breath-exhaling movements, and communicate without obstacles, signed informed consent and with abnormal renal pathology or glomerular filtration rate(GFR) (15 <GFR<90 ml/min.1.73 m2) or proteinuria > 1 g/24 h due to any cause. For fDGF in kidney transplantation patient :18-65 years old patient who can cooperate with breath-holding, breath-holding and breath-exhaling movements, and communicate without obstacles, signed informed consent and received Kidney transplant recipients in our hospital from May 2019 to November 2019.
Key inclusion criteria (7 listed)
- for A on C group 1.18-70 years old; gender is not limited; 2. Patients who can cooperate with breath-holding, breath-holding and breath-exhaling movements, and communicate without obstacles.
- 3.The informed consent has been signed; 4.Abnormal renal pathology or glomerular filtration rate(GFR) (15 <GFR<90 ml/min.1.73 m2) or proteinuria > 1 g/24 h due to any cause.
- for kidney transplantation
Key exclusion criteria (11 listed)
- for A on C group
- b）for kidney transplantation
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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 |
|---|---|---|
| Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography)Compare the ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography) with the diagnostic gold standard of kidney disease---kidney biopsy | Diagnostic test | A on C group, Normal, functional delayed graft function group |
Primary outcome
Number of patients with creatinine increasing by more than 50%
Time frame: 1st month-12 month
Number of patients with creatinine increasing by more than 50% of baseline.
Number of patients with initiation of continuous renal replacement therapy
Time frame: 1st month-12 month
for non-transplantation patient
Rate of death
Time frame: 1st month-12 month
for all patients
3 secondary outcomes
Number of patients with cardiovascular events
Time frame: 1st month-12 month
Number of patients with cerebrovascular events
Time frame: 1st month-12 month
Number of patients with new serious infections requiring hospitalization
Time frame: 1st month-12 month
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 27 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnostic Imaging and Diagnosis, run by RenJi Hospital at 2 sites in China.
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 7 inclusion and 11 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 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Number of patients with creatinine increasing by more than 50% (time frame: 1st month-12 month). 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 27 Nov 2023.