Lumason Contrast-Enhanced Ultrasound for Kidney Transplantation

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Utah Hospital, Salt Lake City, UT
Lumason Contrast-Enhanced Ultrasound - Drug
Eligibility
18+
All Sexes
Eligible conditions
Kidney Transplantation

Study Summary

This study is evaluating whether contrast-enhanced ultrasound may be useful for detecting kidney transplant complications.

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether Lumason Contrast-Enhanced Ultrasound will improve 2 primary outcomes and 1 secondary outcome in patients with Kidney Transplantation. Measurement will happen over the course of Any Time After Kidney Transplantation.

Any Time After Kidney Transplantation
Biopsy-Proven Acute Rejection
First Post-Operative Week
Dialysis-Defined Delayed Graft Function
Post-Operative Day 1
Biomarker-Defined Delayed Graft Function

Trial Safety

Trial Design

2 Treatment Groups

No Control Group
CEUS and Biopsy-Proven Acute Rejection

This trial requires 55 total participants across 2 different treatment groups

This trial involves 2 different treatments. Lumason Contrast-Enhanced Ultrasound is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

CEUS and Biopsy-Proven Acute Rejection
Drug
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.
CEUS and Delayed Graft Function
Drug
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: first post-operative week
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly first post-operative week for reporting.

Closest Location

University of Utah Hospital - Salt Lake City, UT

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Adult living-donor or deceased-donor kidney transplant recipients

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of kidney transplantation?

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A nephrectomy in [kidney transplant](https://www.withpower.com/clinical-trials/kidney-transplant)ation is mainly indicated if a functional graft cannot be maintained. A histological diagnosis is made when posttransplantation graft dysfunction (such as proteinuria) or glomerulosclerosis is present. A pathological evaluation of all grafts is necessary. Nephrectomies in a previously functioning graft can be indicated as a treatment option when it is a prerequisite for subsequent transplantation. In the case of malignancy, this treatment option is not possible. The posttransplantation management in this case is determined by the indication of malignancy. In summary, nephrectomy should be considered in cases of renal failure or a malignancy in a transplanted kidney.

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What causes kidney transplantation?

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Although a small number of patients have [kidney transplant](https://www.withpower.com/clinical-trials/kidney-transplant)s purely for economic motives, the majority may derive substantial gains. A number do so as patients with end stage renal disease, others as transplants for familial cystic kidney disease. In certain countries, kidney transplantation is performed for purely financial motives, for example in Brazil, India and Russia. This is an ethical dilemma as the patients have poor insight to the nature and magnitude of their plight. The question is also complicated because renal units are scarce. We argue that there is a distinction in the treatment of end stage renal disease between people who require dialysis and those who should receive, regardless of the financial benefits.

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Can kidney transplantation be cured?

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While the initial excitement is over, there is no cure for transplant rejection. Kidney transplantation is still a life-saving treatment for end-stage renal disease, and the potential benefit to the recipient and patient of kidney transplantation is profound.

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How many people get kidney transplantation a year in the United States?

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Approximately 25,000 US renal transplant recipients are awaiting a kidney transplant each year. On average, 4.5 patients die while waiting for a kidney transplant. Survival is better after kidney transplantation but patients may be at greater risk for future malignancies and heart disease.

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What are common treatments for kidney transplantation?

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There are multiple common treatments and procedures for kidney transplantation. The procedure of choice depends on the location and type of donated kidney, and the recipient’s health. The most common options include corticosteroid therapy, anti-rejection, hemodialysis therapy, plasmapheresis, intravenous immunoglobulin, medications that inhibit tacrolimus (Ciclosporin), interferon alfa-2b, and corticosteroids in those who are on immunosuppressants.

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What is kidney transplantation?

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It is the replacement of a malfunctioning or diseased kidney with a healthy kidney of the same or another species. Most common type is a donor-recipient transplantation between members of the same species. Kidney transplantation is a highly effective treatment of end-stage kidney disease and an established treatment for select, chronic indications such as autoimmune kidney diseases, hereditary renal diseases, and other genic renal diseases. It is also a potentially curative treatment option for the most common indications of dialysis, and the number of recipients is rising exponentially, especially in Europe.

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Who should consider clinical trials for kidney transplantation?

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Clinical trials are an important route for the introduction of new treatments to those on waiting lists for organs. Despite the high probability of rejection in patients who must endure several years of medication before being transplanted, some patients have lived longer than 5 years on the kidney waiting list. Most clinical trials are conducted in the United States and Canada but the National Transplant Network offers free consultation to patients from the United Kingdom in relation to clinical trials for transplant. At present, the National Transplant Network receives information from many countries and they can assist patients in contacting clinical trials in other countries. Most clinical trials are in the first year after transplantation, but there should be more studies on the late effects of the transplant disease.

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What is the latest research for kidney transplantation?

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The existing information about this topic is limited to a limited number of recent and rigorous publications. It is suggested to perform some rigorous and well-designed RCTs to provide more knowledge about kidney transplantation to optimize its long-term outcomes.

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How serious can kidney transplantation be?

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Almost all patients are well within the first year after transplantation when they are followed by generalist nephrology clinics. However, if they do have kidney symptoms, they tend to be long-term problems. This problem seems more relevant in renal replacement treatment than in the medical management of patients with end stage kidney disease.

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Does lumason contrast-enhanced ultrasound improve quality of life for those with kidney transplantation?

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Lumason CEUS is a highly useful method not only for detecting small renal tumors but also for enhancing tumoral-vessel contrast and delineating vascularity. The application of Lumason CEUS will improve quality of life for patients after renal transplantation, and may alleviate patients' fear and anxiety.

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Have there been other clinical trials involving lumason contrast-enhanced ultrasound?

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There has been some clinical trial evidence of improved cancer outcomes after CHEUS. However, further work is required to establish a full evidence base. The most advanced clinical trials to date are evaluating CHEUS for renal and non-renal cancers. Future clinical trial design considerations should be based on the existing evidence, considering the limitations of CHEUS and the potential advantages of lumason.

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How does lumason contrast-enhanced ultrasound work?

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Contrary to clinical opinion, the Lumason Imaging System provides good contrast using a low-molecular-weight contrast agent, and thus it may be used to distinguish solid renal lesions from other cysts.

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