A Study of Renal Microvessel Imaging for Chronic Kidney Disease

Mayo Clinic

Status and phase: Invitation-only; Phase 2

Conditions: Chronic Kidney Diseases; Healthy

Treatments: Diagnostic Test: Super-resolution ultrasound imaging; Drug: Definity

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05764642

R01DK129205 (U.S. NIH Grant/Contract)

22-006499

Details and patient eligibility

About

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.

Enrollment: 186 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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186 participants in 2 patient groups

Chronic Kidney Disease Group

Experimental group

Description:

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.

Treatment:

Drug: Definity

Diagnostic Test: Super-resolution ultrasound imaging

Healthy Control Group

Active Comparator group

Description:

Healthy volunteers with normal eGFR will have microvessel images obtained by Super-Resolution Ultrasound Imaging (SRUI) using Definity ultrasound contrast agent.

Treatment:

Drug: Definity

Diagnostic Test: Super-resolution ultrasound imaging