What side effects are associated with this type of intervention?

Contrast-Enhanced Ultrasound (CEUS) using Lumason for kidney transplants is generally well-tolerated, but potential side effects include mild reactions such as headache, nausea, and injection site reactions. Serious adverse effects are rare but can include hypersensitivity reactions. For broader kidney transplant treatments, common side effects of immunosuppressive therapies include increased risk of infections, impaired glucose tolerance, weight gain, and potential kidney toxicity. It is important to discuss these risks with a healthcare provider to tailor the treatment plan to individual needs.

What prior FDA approvals exist?

The FDA has approved several intravenous contrast agents for enhancing ultrasound imaging, which are relevant to kidney transplant care. These agents include Optison, Definity, and Lumason. Lumason, in particular, has been approved for contrast-enhanced ultrasound of the liver and is being studied for its potential to improve visualization of kidney allografts, aiding in the early detection of complications such as delayed graft function and acute allograft rejection.

What other types of research exist?

Promising alternatives to CEUS with Lumason for kidney transplant patients include: 1) Multiparametric MRI, which combines different MRI sequences to provide detailed information about tissue structure and function without the need for contrast agents. 2) Shear Wave Elastography, a non-invasive ultrasound technique that measures tissue stiffness and can help detect fibrosis and other complications. 3) Advanced CT imaging techniques, such as dual-energy CT, which can provide detailed vascular and tissue characterization. These alternatives offer non-invasive options with potential for early detection of transplant complications.

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Contrast-Enhanced Ultrasound for Kidney Transplant Complications

Phase 1

Waitlist Available

Led By Isaac E Hall, M.D.

Research Sponsored by Isaac E. Hall

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult living-donor or deceased-donor kidney transplant recipients

Be older than 18 years old

Must not have

Uncontrolled diabetes or hypertension

Symptomatic or significant pulmonary or cardiovascular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first post-operative week

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing a new ultrasound technique with a special contrast agent to better detect problems in kidney transplant patients. It aims to find issues like delayed graft function and rejection earlier than current methods. This could help avoid invasive biopsies and improve long-term outcomes for patients. The new ultrasound method offers a non-invasive alternative to traditional biopsy methods.

Who is the study for?

This trial is for adults who have received a kidney transplant from either a living or deceased donor. It's not suitable for pregnant individuals, those with unstable medical/surgical conditions, previous non-renal transplants, uncontrolled diabetes or hypertension, or serious lung/heart disease.

What is being tested?

The study tests Lumason Contrast-Enhanced Ultrasound (CEUS) to detect early complications in kidney transplants like delayed function and rejection. CEUS uses an IV contrast agent with ultrasound to better visualize the new kidney compared to standard methods.

What are the potential side effects?

While generally safe and non-invasive, contrast agents used in CEUS can sometimes cause mild side effects such as nausea, headache, flushing or allergic reactions. Serious side effects are rare but may include heart problems or severe allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have received a kidney transplant from a living or deceased donor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My diabetes or blood pressure is not well-controlled.

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I have serious lung or heart disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-operative day 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-operative day 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-operative day 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Biomarker-Defined Delayed Graft Function

Biopsy-Proven Acute Rejection

Secondary study objectives

Dialysis-Defined Delayed Graft Function

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: CEUS and Delayed Graft FunctionExperimental Treatment1 Intervention

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.

Group II: CEUS and Biopsy-Proven Acute RejectionExperimental Treatment1 Intervention

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.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Contrast-enhanced ultrasound (CEUS) with Lumason improves kidney transplant outcomes by using an intravenous contrast agent to enhance organ visualization. This technique allows for the early detection of complications such as delayed graft function and acute rejection, which are critical for timely intervention and management. By providing clearer images of the kidney allograft, CEUS helps healthcare providers monitor the transplant's health more effectively, leading to better patient outcomes and potentially reducing the need for more invasive procedures like biopsies.

Renal transplants: what ultrasound can and cannot do.