HealthyPhase 2NCT05764642
A Study of Renal Microvessel Imaging for Chronic Kidney Disease
A Phase 2 study testing Definity and Super-resolution ultrasound imaging in people with Healthy and Chronic Kidney Diseases, run by Mayo Clinic at 2 sites in United States.
Trial summary
The purpose of this research is to study the efficacy of ultrasound microvessel imaging for evaluation of Chronic Kidney Disease. Definity is an ultrasound contrast agent currently approved by the FDA for use on the heart, liver, and urinary tract. This study will look at its effectiveness on the kidney. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Chronic Kidney Diseases
- What is being tested?
- Definity and Super-resolution ultrasound imaging
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Aug 2023to Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers or Chronic Kidney Disease (CKD) patients with clinically indicated renal biopsy.
Who cannot join
- Subjects lacking capacity to consent.
- Vulnerable subjects such as prisoners; pregnant women; nursing mother.
- Subjects with history of hypersensitivity allergic reactions to ultrasound contrast agents.
- Patients with high-risk cardiac diseases.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Mayo Clinic Florida
Jacksonville, Florida, 32224
Mayo Clinic Minnesota
Rochester, Minnesota, 55905
About this study
Official title: Renal Microvessel Imaging for Characterization of Chronic Kidney Disease
The purpose of this research is to study the efficacy of ultrasound microvessel imaging for evaluation of Chronic Kidney Disease. Definity is an ultrasound contrast agent currently approved by the FDA for use on the heart, liver, and urinary tract. This study will look at its effectiveness on the kidney.
- Conditions
- Healthy, Chronic Kidney Diseases
- Being tested
- Definity, Super-resolution ultrasound imaging
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DefinityDrug
Also called Perflutren Lipid Microsphere
Ultrasound contrast agent administered intravenously
Super-resolution ultrasound imagingDiagnostic test
Also called SRUI
Imaging technology for microvessel imaging. This technology localizes and tracks individual microbubbles (FDA approved ultrasound contrast agents) to map microvessel morphology and flow speed at a spatial resolution about 10 times higher than conventional ultrasound imaging.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Kidney Disease Group | Experimental | Subjects with Chronic Kidney Disease (CKD) with clinically indicated renal biopsy will have microvessel images obtained by Super-Resolution Ultrasound Imaging (SRUI) using Definity ultrasound contrast agent. Receives: Drug: Definity; Diagnostic Test: Super-resolution ultrasound imaging |
| Healthy Control Group | Active comparator | Healthy volunteers with normal eGFR will have microvessel images obtained by Super-Resolution Ultrasound Imaging (SRUI) using Definity ultrasound contrast agent. Receives: Drug: Definity; Diagnostic Test: Super-resolution ultrasound imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal cortex microvessel density
Super-Resolution Ultrasound Imaging (SRUI) parameters reported in percentage
Measured: Baseline
Renal cortex microvessel diameter
Super-Resolution Ultrasound Imaging (SRUI) parameters reported in millimeters (mm)
Measured: Baseline
Renal blood flow velocity
Super-Resolution Ultrasound Imaging (SRUI) parameters reported in centimeters per second (cm/sec)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start9 Aug 2023
- Primary completion1 Apr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shigao Chen, Mayo Clinic
- Investigators
- Shigao Chen, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764642
- Sponsor's protocol ID
- 22-006499
- Other IDs
- R01DK129205
- Status last verified
- Sep 2026
- First submitted
- 28 Feb 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Microvessel Imaging for Characterization of Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05764642
- Acronym / sponsor ID
- 22-006499
- Conditions
- Healthy, Chronic Kidney Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 10 Mar 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.
The purpose of this research is to study the efficacy of ultrasound microvessel imaging for evaluation of Chronic Kidney Disease. Definity is an ultrasound contrast agent currently approved by the FDA for use on the heart, liver, and urinary tract. This study will look at its effectiveness on the kidney.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Kidney Disease Group | Experimental | Drug: Definity, Diagnostic Test: Super-resolution ultrasound imagingSubjects with Chronic Kidney Disease (CKD) with clinically indicated renal biopsy will have microvessel images obtained by Super-Resolution Ultrasound Imaging (SRUI) using Definity ultrasound contrast agent. |
| Healthy Control Group | Active comparator | Drug: Definity, Diagnostic Test: Super-resolution ultrasound imagingHealthy volunteers with normal eGFR will have microvessel images obtained by Super-Resolution Ultrasound Imaging (SRUI) using Definity ultrasound contrast agent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers or Chronic Kidney Disease (CKD) patients with clinically indicated renal biopsy.
Key exclusion criteria (4 listed)
- Subjects lacking capacity to consent.
- Vulnerable subjects such as prisoners; pregnant women; nursing mother.
- Subjects with history of hypersensitivity allergic reactions to ultrasound contrast agents.
- Patients with high-risk cardiac diseases.
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 |
|---|---|---|
| DefinityAlso: Perflutren Lipid MicrosphereUltrasound contrast agent administered intravenously | Drug | Chronic Kidney Disease Group, Healthy Control Group |
| Super-resolution ultrasound imagingAlso: SRUIImaging technology for microvessel imaging. This technology localizes and tracks individual microbubbles (FDA approved ultrasound contrast agents) to map microvessel morphology and flow speed at a spatial resolution about 10 times higher than conventional ultrasound imaging. | Diagnostic test | Chronic Kidney Disease Group, Healthy Control Group |
Primary outcome
Renal cortex microvessel density
Time frame: Baseline
Super-Resolution Ultrasound Imaging (SRUI) parameters reported in percentage
Renal cortex microvessel diameter
Time frame: Baseline
Super-Resolution Ultrasound Imaging (SRUI) parameters reported in millimeters (mm)
Renal blood flow velocity
Time frame: Baseline
Super-Resolution Ultrasound Imaging (SRUI) parameters reported in centimeters per second (cm/sec)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- 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.
Shigao Chen, PhD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Definity and Super-resolution ultrasound imaging in people with Healthy and Chronic Kidney Diseases, run by Mayo Clinic at 2 sites in United States.
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 4 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: enrolling by invitation, as of the sponsor's last update on 11 Sep 2026. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Renal cortex microvessel density (time frame: Baseline). 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 11 Sep 2026.