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Enrolling by invitation NCT05764642

A Study of Renal Microvessel Imaging for Chronic Kidney Disease

Phase II Interventional Healthy Chronic Kidney Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Definity, Super-resolution ultrasound imaging.
Who it may be relevant to
Registry conditions: Healthy, Chronic Kidney Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Renal Microvessel Imaging for Characterization of Chronic Kidney Disease

Overview

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.

Interventions

  • Drug Definity
    Ultrasound contrast agent administered intravenously
  • Diagnostic test Super-resolution ultrasound imaging
    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.

Primary outcome measures

  • Renal cortex microvessel density [Time frame: Baseline]
  • Renal cortex microvessel diameter [Time frame: Baseline]
  • Renal blood flow velocity [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

\- Healthy volunteers or Chronic Kidney Disease (CKD) patients with clinically indicated renal biopsy.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 2 centers
  • Mayo Clinic Florida — Jacksonville
  • Mayo Clinic Minnesota — Rochester

Identifiers

NCT: NCT05764642 · 22-006499 · R01DK129205

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗