Autosomal Dominant Polycystic Kidney DiseaseNCT05288998
Intrarenal Microvasculature in ADPKD
An observational study of Autosomal Dominant Polycystic Kidney Disease, run by Mayo Clinic at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the use of Super-resolution ultrasound (SRU) to assess the intrarenal microvasculature in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) and healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney Disease
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2021to Dec 2026
- Phase
- Observational
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with a previous diagnosis of ADPKD that meet the inclusion criteria, and healthy volunteers
Who may be able to join
- Male and female subjects 18 - 40 years of age, inclusive
- Previous diagnosis of ADPKD (based on Ravine et al. criteria)
- Class 1 according to imaging classification
- Estimated GFR> 90 mL/min/m2 (CKD-Epi equation)
- Ability to provide written, informed consent
- Male and female subjects 18 - 40 years of age, inclusive
- Estimated GFR> 90 mL/min/m2 (CKD-Epi equation)
- Ability to provide written, informed consent
Who cannot join
- Class 2 according to imaging classification
- A concomitant systemic disease affecting the kidney (e.g., lupus, hepatitis B or C, amyloidosis)
- Diabetes mellitus (fasting glucose > 126 mg/dL or treatment with insulin or oral hypoglycemics).
- Predicted urine protein excretion in urinalysis >1 g/24 hrs.
- Subjects having contraindications to or interference with MRI assessments. [For example ferromagnetic metal prostheses, aneurysm clips, severe claustrophobia, large abdominal/back tattoos, etc.].
- History of hypersensitivity allergic reactions to ultrasound contrast agents
Show all 17Show fewer
- High-risk cardiac disease (such as unstable hospital in-patients or ICU patients
- Patients that are part of an interventional study or are taking tolvaptan
- Female subjects that are pregnant
- Family and/or personal history of kidney disease
- Concomitant systemic disease that may affect the kidney
- Diabetes mellitus
- Predicted urine protein excretion in >1 g/24 hrs, and or Abnormal urinalysis
- Pregnant or lactating women
- Subjects having contraindications to or interference with MRI assessments. [For example ferromagnetic metal prostheses, aneurysm clips, severe claustrophobia, large abdominal/back tattoos, etc.].
- History of hypersensitivity allergic reactions to ultrasound contrast agents
- High risk cardiac disease (such as unstable hospital in-patients or ICU patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Noninvasive Evaluation of the Intrarenal Microvasculature in ADPKD
The primary objective of this study is to evaluate the use of Super-resolution ultrasound (SRU) to assess the intrarenal microvasculature in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) and healthy volunteers.
Read the detailed description
An intact intrarenal microcirculation is vital to preserving normal kidney function, and microvascular dysfunction, damage, and loss are known to contribute to renal function decline. In ADPKD, extensive vascular remodeling has been proposed to play an important role in its progression. However, microvascular analyses in rodents and humans with ADPKD have been performed ex vivo or in vitro and from kidneys removed at the time of renal failure due to the invasive nature and additional limitations of the currently available techniques. A non-invasive and direct method to assess the intrarenal microvasculature is needed to improve early detection and gauge the progression of microvascular alterations and monitor the success of therapeutic approaches.
Current imaging modalities, such as micro-computed tomography, magnetic resonance imaging, and contrast-enhanced ultrasound, have attempted to provide a non-invasive assessment of the intrarenal microvasculature in pre-clinical models of kidney diseases. However, each of these modalities has important limitations when translating into humans, including high cost, requiring long imaging times, using nephrotoxic contrast agents, radiation exposure, low spatial resolution, and poor reproducibility.
Super-resolution ultrasound (SRU) imaging is among the most rapidly advancing imaging techniques introduced to overcome the limitation of the inherent spatial resolution of ultrasound. With the use of non-nephrotoxic contrast microbubbles to break the diffraction limit of ultrasound, and the introduction of ultrasound localization microscopy which utilizes ultrafast frame rate imaging to reconstruct a super-resolved composite image, SRU has provided a paradigm-shifting tool for structural and functional evaluation of tissue microvasculature. However, in vivo, human imaging, and kidney imaging pose significant organ depth challenges (which results in ultrasound signals with lower signal-to-noise ratio) and physiologic and operator-induced motion (which reduces the available data accumulation time). Our team recently implemented advanced filtering and microbubble localization and tracking techniques to overcome these limitations, which extract only microbubble signals and reliably pinpoint the center of each microbubble from the extracted signals.
The investigators' broad objective is to deploy and evaluate the use of SRU imaging coupled with advanced post-processing techniques to assess the intrarenal microvasculature in patients with early ADPKD and healthy volunteers.
Participants in this study will have a renal ultrasound to determine intrarenal microvascular parameters, and an abdominal MRI to determine the patient's total kidney volume (TKV), and additional vascular parameters. In addition, participants will have a blood and a urine sample collected to determine biomarkers of endothelial function and injury.
- Keywords
- ADPKD, Intrarenal microvasculature
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with a previous diagnosis of ADPKD | Patients that have been diagnosed with ADPKD and meet the study's inclusion criteria | |
| Healthy Volunteers | Subjects without a family or personal history of kidney disease or concomitant systemic disorder that might affect the kidney |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of intrarenal microvascular density in HV and patients with ADPKD
Renal vessel density as percentage, determined by SRU.
Measured: Baseline
Assessment of intrarenal microvascular flow speed in HV and patients with ADPKD
Microvascular flow speed (mm/s), determined by SRU.
Measured: Baseline
Assessment of intrarenal microvascular perfusion in HV and patients with ADPKD
Intrarenal perfusion (mm/s), determined by SRU.
Measured: Baseline
Assessment of intrarenal tortuosity indices in HV and patients with ADPKD
Tortuosity indices defined as sum of angles metric (SOAM) (rad/mm), determined by SRU
Measured: Baseline
Secondary outcomes (3)
Inter-sonographer variability of the intrarenal microvasculature
Second US at the same visit performed by a different sonographer, and used to calculate the intraclass correlation coefficient
Measured: Baseline
Day-to-day variability of intrarenal microvasculature in healthy volunteers
A second US within 1-7 days is performed by the same sonographer, to determine the within-person variability for each of the primary outcome measures
Measured: Baseline to 7 days
Patient-to-patient variability in patients with ADPKD
Correlation between primary outcome measures and image class (A, B, C, D and E) as determined by the Image classification.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start30 Nov 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autosomal Dominant Polycystic Kidney DiseaseStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria V. Irazabal Mira, Mayo Clinic
- Investigators
- Maria V Irazabal, M.D., Ph.D, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288998
- Sponsor's protocol ID
- 21-005117
- Other IDs
- 1R21DK129886-01
- Status last verified
- Jan 2026
- First submitted
- 21 Feb 2022
- Last updated
- 16 Jan 2026
- 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 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Evaluation of the Intrarenal Microvasculature in ADPKD
- ClinicalTrials.gov ID
- NCT05288998
- Acronym / sponsor ID
- 21-005117
- Keywords
- ADPKD, Intrarenal microvasculature
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Mar 2022 (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 primary objective of this study is to evaluate the use of Super-resolution ultrasound (SRU) to assess the intrarenal microvasculature in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) and healthy volunteers.
Detailed description
An intact intrarenal microcirculation is vital to preserving normal kidney function, and microvascular dysfunction, damage, and loss are known to contribute to renal function decline. In ADPKD, extensive vascular remodeling has been proposed to play an important role in its progression. However, microvascular analyses in rodents and humans with ADPKD have been performed ex vivo or in vitro and from kidneys removed at the time of renal failure due to the invasive nature and additional limitations of the currently available techniques. A non-invasive and direct method to assess the intrarenal microvasculature is needed to improve early detection and gauge the progression of microvascular alterations and monitor the success of therapeutic approaches.
Current imaging modalities, such as micro-computed tomography, magnetic resonance imaging, and contrast-enhanced ultrasound, have attempted to provide a non-invasive assessment of the intrarenal microvasculature in pre-clinical models of kidney diseases. However, each of these modalities has important limitations when translating into humans, including high cost, requiring long imaging times, using nephrotoxic contrast agents, radiation exposure, low spatial resolution, and poor reproducibility.
Super-resolution ultrasound (SRU) imaging is among the most rapidly advancing imaging techniques introduced to overcome the limitation of the inherent spatial resolution of ultrasound. With the use of non-nephrotoxic contrast microbubbles to break the diffraction limit of ultrasound, and the introduction of ultrasound localization microscopy which utilizes ultrafast frame rate imaging to reconstruct a super-resolved composite image, SRU has provided a paradigm-shifting tool for structural and functional evaluation of tissue microvasculature. However, in vivo, human imaging, and kidney imaging pose significant organ depth challenges (which results in ultrasound signals with lower signal-to-noise ratio) and physiologic and operator-induced motion (which reduces the available data accumulation time). Our team recently implemented advanced filtering and microbubble localization and tracking techniques to overcome these limitations, which extract only microbubble signals and reliably pinpoint the center of each microbubble from the extracted signals.
The investigators' broad objective is to deploy and evaluate the use of SRU imaging coupled with advanced post-processing techniques to assess the intrarenal microvasculature in patients with early ADPKD and healthy volunteers.
Participants in this study will have a renal ultrasound to determine intrarenal microvascular parameters, and an abdominal MRI to determine the patient's total kidney volume (TKV), and additional vascular parameters. In addition, participants will have a blood and a urine sample collected to determine biomarkers of endothelial function and injury.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with a previous diagnosis of ADPKD | – | –Patients that have been diagnosed with ADPKD and meet the study's inclusion criteria |
| Healthy Volunteers | – | –Subjects without a family or personal history of kidney disease or concomitant systemic disorder that might affect the kidney |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with a previous diagnosis of ADPKD that meet the inclusion criteria, and healthy volunteers
Key inclusion criteria (8 listed)
- Male and female subjects 18 - 40 years of age, inclusive
- Previous diagnosis of ADPKD (based on Ravine et al. criteria)
- Class 1 according to imaging classification
- Estimated GFR> 90 mL/min/m2 (CKD-Epi equation)
- Ability to provide written, informed consent
Key exclusion criteria (17 listed)
- Class 2 according to imaging classification
- A concomitant systemic disease affecting the kidney (e.g., lupus, hepatitis B or C, amyloidosis)
- Diabetes mellitus (fasting glucose > 126 mg/dL or treatment with insulin or oral hypoglycemics).
- Predicted urine protein excretion in urinalysis >1 g/24 hrs.
- Subjects having contraindications to or interference with MRI assessments. [For example ferromagnetic metal prostheses, aneurysm clips, severe claustrophobia, large abdominal/back tattoos, etc.].
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of intrarenal microvascular density in HV and patients with ADPKD
Time frame: Baseline
Renal vessel density as percentage, determined by SRU.
Assessment of intrarenal microvascular flow speed in HV and patients with ADPKD
Time frame: Baseline
Microvascular flow speed (mm/s), determined by SRU.
Assessment of intrarenal microvascular perfusion in HV and patients with ADPKD
Time frame: Baseline
Intrarenal perfusion (mm/s), determined by SRU.
Assessment of intrarenal tortuosity indices in HV and patients with ADPKD
Time frame: Baseline
Tortuosity indices defined as sum of angles metric (SOAM) (rad/mm), determined by SRU
3 secondary outcomes
Inter-sonographer variability of the intrarenal microvasculature
Time frame: Baseline
Day-to-day variability of intrarenal microvasculature in healthy volunteers
Time frame: Baseline to 7 days
Patient-to-patient variability in patients with ADPKD
Time frame: Baseline
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 16 Jan 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. This study is not recruiting at the moment.
Maria V Irazabal, M.D., Ph.D principal investigator
Mayo Clinic
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 Autosomal Dominant Polycystic Kidney Disease, run by Mayo Clinic at 1 site 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 8 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2026. 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 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.
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?
Assessment of intrarenal microvascular density in HV and patients with ADPKD (time frame: Baseline). The study lists 4 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 16 Jan 2026.