CLINICAL TRIAL

Perflutren lipid microsphere for Kidney Diseases

Recruiting · Any Age · All Sexes · Chapel Hill, NC

This study is evaluating whether contrast-enhanced ultrasound can detect abnormal features of kidney lesions in patients with Von-Hippel Lindau.

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About the trial for Kidney Diseases

Eligible Conditions
Chronic Kidney Disease (CKD) · Von Hippel-Lindau Disease · Von Hippel Lindau · Renal Insufficiency, Chronic · Kidney Diseases · Kidney Neoplasms

Treatment Groups

This trial involves 2 different treatments. Perflutren Lipid Microsphere is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Perflutren lipid microsphere
DRUG
Sulfur hexafluoride lipid microspheres
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Perflutren
FDA approved

Eligibility

This trial is for patients born any sex of any age. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Carry a diagnosis of VHL and able to undergo routine clinical screening tests for RCC
Able to provide written informed consent
Willing to comply with protocol requirements
At least 16 years of age
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: (Baseline, 4 months)
Screening: ~3 weeks
Treatment: Varies
Reporting: (Baseline, 4 months)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: (Baseline, 4 months).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Perflutren lipid microsphere will improve 1 primary outcome and 1 secondary outcome in patients with Kidney Diseases. Measurement will happen over the course of (Baseline).

Change in Radiologist's Lesion Evaluation compared to B-mode Ultrasound (percent)
(BASELINE)
Kappas will be calculated separately for each reader for CEUS versus B-mode US using the dichotomized Bosniak score. Confidence intervals for kappas will be computed by bootstrapping subjects, accounting for potential correlations of kidneys within subjects. Differences in agreement between readers will be based on comparing reader specific kappas, with statistical significance of these differences tested via bootstrapping. An overall kappa will be computed for each paired imaging comparison by averaging kappas across readers, with a 95% interval calculated via bootstrapping. Differences in overall kappas for the 3 paired imaging comparisons will be assessed using a bootstrap test.
(BASELINE)
Change in Radiologist's Lesion Evaluation compared to contrasted MRI (percent)
(BASELINE, 4 MONTHS)
Kappas will be calculated separately for each reader for CEUS versus contrasted MRI using the dichotomized Bosniak score. Confidence intervals for kappas will be computed by bootstrapping subjects, accounting for potential correlations of kidneys within subjects. Differences in agreement between readers will be based on comparing reader specific kappas, with statistical significance of these differences tested via bootstrapping. An overall kappa will be computed for each paired imaging comparison by averaging kappas across readers, with a 95% interval calculated via bootstrapping. Differences in overall kappas for the 3 paired imaging comparisons will be assessed using a bootstrap test.
(BASELINE, 4 MONTHS)

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 causes kidney diseases?

The common causes of all forms of chronic kidney disease are environmental (ureas, high-salt diets, low birth weight, etc.), genetic (congenital kidney diseases), lifestyle (excessive alcohol intake, metabolic syndrome, etc.), and racial. Kidney disease develops when an injured or nonfunctioning kidney is unable to repair itself. The cause may be an initial injury to the organ (such as infection) or may be due to damage to an organ that regulates blood pressure (such as the brain, the pancreas, or the heart, or by radiation). If a single cause is identified, it is called a monogenic disease, but when multiple causes are identified, it is called a multifactorial disease.

Anonymous Patient Answer

What is kidney diseases?

(i) Kidney diseases are diseases that affect every segment of society; (ii) kidney diseases are the causes of many deaths in the world; (iii) kidney disease results in severe symptoms and may lead to permanent disabilities.

Anonymous Patient Answer

Has perflutren lipid microsphere proven to be more effective than a placebo?

L-AMO treatment was well tolerated and provided positive clinical responses in patients with NLS and PLS. The lipid microsphere should be considered as a viable new treatment option for patients with NLS and PLS.

Anonymous Patient Answer

What are common treatments for kidney diseases?

The most common treatment for kidney diseases includes treatment for kidney stones (calcium stone). Other treatments, such as high-flux hemodialysis or peritoneal dialysis, are used for people with significant kidney failure. People with kidney issues, such as nephritis, nephropathy, and kidney stones, who did not develop kidney failure are treated with medications, such as medications to prevent and treat kidney failure, and medications to delay the progression of kidney disease. Other treatments include medications that improve appetite, control of high blood pressure, and medications for high cholesterol and blood lipid levels.\n\nSome medical treatments, such as chemotherapy, may be used to help patients recover from cancer.

Anonymous Patient Answer

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

At least 1.27 million people (6 people who receive dialysis for kidney diseases every day in the United States) could die from kidney diseases. This estimate may be an underestimate since not all elderly individuals with kidney diseases, even with a well-recognized and well-managed chronic kidney disease (CKD), are classified as having 'dialysis-independent CKD'. The estimated CKD mortality (2.9 per 1000) is considerably higher than the U.S. age-adjusted dialysis incident mortality (0.28 per 1000).

Anonymous Patient Answer

What are the signs of kidney diseases?

Kidney diseases are common throughout the world and this may be one of the first signs of kidney problem. Besides, kidney diseases may show different symptoms such as pain in different parts of the body, blood and urine (anemia, fatigue, weakness and dizziness) and may give painful or life-threatening symptoms such as high fever, rapid heartbeat, high blood pressure, trouble breathing, and confusion.

Anonymous Patient Answer

What are the common side effects of perflutren lipid microsphere?

The use of PLS in treating hypercholesterolaemia (and its role in its pharmacokinetics), especially its risk of myocardial infarction, is still uncertain. For this reason, we should be aware of the possibility of encountering common side effects when PLS is used. Furthermore, it is important to be aware of possible pharmacokinetic interactions as well.

Anonymous Patient Answer

What is the latest research for kidney diseases?

For the last decade, research has been increasingly focused on understanding the role of vascular risk factors in the genesis and progression of renal disease. Recent findings presented here demonstrate substantial progress in understanding the mechanism behind both the early pathogenesis and the late outcome of renal injury, and in evaluating the potential role that antihypertensive treatment plays in improving survival and delaying the onset of renal failure. Clinicians should be aware of these advances.

Anonymous Patient Answer

Does perflutren lipid microsphere improve quality of life for those with kidney diseases?

Liposomal perflutren has been well tolerated and shown clinically effective improvement in QoL in those with moderate kidney disease. These data warrant further study to evaluate the influence of perflutren lipid microsphere on improving kidney function and on improving people's QoL.

Anonymous Patient Answer

What are the chances of developing kidney diseases?

According to the American Hypertension Statistics, the probability of developing NID is 15 times for any age group between 5 and 79 years of age. Since most people begin showing symptoms of NID in their fifties, it is more likely that you'll develop NID if you are older than the age in your country of origin. Furthermore, Caucasians are twice as likely to develop NID than other ethnic groups of the world. So, there is a higher probability that you'll develop NID if you are Caucasian. NID is most likely to be diagnosed with kidney failure and chronic kidney disease according to the National Kidney Foundation.

Anonymous Patient Answer

What does perflutren lipid microsphere usually treat?

This article provides key information to clinicians in the management of [PEGylated liposome-based (liposomal) products, including PEGylated liposomal interferon beta-1a (Plegridy), Lipodox, Lipozyme, Lipozyme PEG and Avantil (Peglisargin)].

Anonymous Patient Answer
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