Contrast-Enhanced Ultrasound for Kidney Transplant

NCT02911714 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: IRB_00092223KL2TR002539
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Contrast-enhanced ultrasound (CEUS) is a promising non-invasive imaging tool that may aid in the early detection of kidney transplant complications, such as delayed graft function (DGF) and acute allograft rejection. The technique uses an intravenous contrast agent to improve organ visualization with standard duplex ultrasound equipment. A number of FDA-approved agents, including Optison, Definity and Lumason are widely used to improve visualization in technically limited echocardiograms, and Lumason was recently approved for contrast-enhanced ultrasound of the liver. The specific aims of this study are to: develop, implement and refine a contrast-enhanced ultrasound protocol using Lumason to safely maximize kidney allograft visualization; determine associations between contrast-enhanced ultrasound and patterns of allograft injury consistent with delayed graft function; and to compare contrast-enhanced ultrasound with duplex ultrasound for differentiating acute rejection from other causes of dysfunction.

Conditions

Kidney Transplantation

Keywords

Kidney Transplantation; Delayed Graft Function; Acute Allograft Rejection; Acute Kidney Injury

Outcome Measures

Primary Outcomes (2)

• Biomarker-Defined Delayed Graft Function

  A meta-analysis of 19 studies found urine neutrophil gelatinase-associated lipocalin (NGAL) \>150 ng/mL (within hours of the inciting event) had an area under the receiver-operating characteristic curve (AUC) of 0.815 for identifying acute kidney injury (defined as an ensuing rise in serum creatinine by ≥50%). We noted an AUC of 0.82 for predicting the need for dialysis in the first week (i.e., dialysis-defined delayed graft function) with an optimal urine NGAL cutoff of \>350 ng/mL. For this study outcome, we will determine the Spearman correlation between CEUS-assessed allograft perfusion and degree of allograft injury based on post-operative day 1 urine NGAL concentration.

  Post-Operative Day 1

• Biopsy-Proven Acute Rejection

  The Banff (2013) classification of acute kidney allograft rejection requires histologic evidence of acute tissue injury, evidence of recent antibody interaction with renal vascular endothelium, and serologic evidence of donor-specific antibodies in order to diagnose acute antibody-mediate rejection. Acute T-cell mediated rejection is histologically graded by the extent of interstitial inflammation and vascular involvement.

  Any Time After Kidney Transplantation

Secondary Outcomes (1)

• Dialysis-Defined Delayed Graft Function

  First Post-Operative Week

Study Arms (2)

CEUS and Delayed Graft Function

EXPERIMENTAL

On the first post-operative day after kidney transplantation, recipients enrolled in the study will undergo CEUS using Lumason to quantify microvascular perfusion within the cortical and medullary zones of the kidney allograft for comparison to the concentration of neutrophil gelatinase-associated lipocalin (NGAL, an early biomarker of acute kidney injury) measured from recipient urine simultaneously collected on the first post-operative day.

Drug: Lumason Contrast-Enhanced Ultrasound

CEUS and Biopsy-Proven Acute Rejection

EXPERIMENTAL

We will identify and enroll kidney transplant recipients in need of clinically-indicated duplex ultrasounds and possible biopsy to evaluate allograft dysfunction during hospital admissions and outpatient follow-up. Immediately after the duplex ultrasound, we will perform CEUS using Lumason for allograft perfusion measurements to determine its potential association with biopsy-proven acute rejection according to the most recent Banff criteria.

Drug: Lumason Contrast-Enhanced Ultrasound

Interventions

Lumason Contrast-Enhanced Ultrasound DRUG

In both arms, we will use Lumason to measure kidney allograft perfusion via contrast-enhanced ultrasound.

Also known as: Sulfur hexafluoride lipid-type A microspheres

CEUS and Biopsy-Proven Acute Rejection; CEUS and Delayed Graft Function

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult living-donor or deceased-donor kidney transplant recipients

You may not qualify if:

• Subject is Pregnant
• History of non-renal transplant
• Uncontrolled diabetes or hypertension
• Symptomatic or significant pulmonary or cardiovascular disease
• Clinical decision by the treating team to forego the study procedure due to medical/surgical instability

Sponsors & Collaborators

• National Center for Advancing Translational Sciences (NCATS): collaborator
• University of Utah: lead
• National Kidney Foundation, United States: collaborator
• American Heart Association: collaborator

Study Sites (1)

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Delayed Graft Function; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Isaac E Hall, M.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: September 22, 2016
• Study Start: February 21, 2018
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)