A Study of Renal Microvessel Imaging for Chronic Kidney Disease

Phase 2

• Conditions: Chronic Kidney Diseases; Healthy
• Interventions: Drug: Definity; Diagnostic Test: Super-resolution ultrasound imaging

• Registration Number: NCT05764642
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-02-28
• Study First Posted: 2023-03-10
• Study Start: 2023-08-09
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-17
• Primary Completion: 2028-04-01
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chronic Kidney Disease Group	Super-resolution ultrasound imaging	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.
Healthy Control Group	Super-resolution ultrasound imaging	Healthy volunteers with normal eGFR will have microvessel images obtained by Super-Resolution Ultrasound Imaging (SRUI) using Definity ultrasound contrast agent.
Chronic Kidney Disease Group	Definity	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.
Healthy Control Group	Definity	Healthy volunteers with normal eGFR will have microvessel images obtained by Super-Resolution Ultrasound Imaging (SRUI) using Definity ultrasound contrast agent.

Primary Outcome Measures

Name	Time	Method
Renal cortex microvessel diameter	Baseline	Super-Resolution Ultrasound Imaging (SRUI) parameters reported in millimeters (mm)
Renal blood flow velocity	Baseline	Super-Resolution Ultrasound Imaging (SRUI) parameters reported in centimeters per second (cm/sec)
Renal cortex microvessel density	Baseline	Super-Resolution Ultrasound Imaging (SRUI) parameters reported in percentage

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States