Is NCT04065438 recruiting in Akron, OH?

Yes, NCT04065438 is currently recruiting participants at its Akron, OH location. This focal segmental glomerulosclerosis clinical trial is actively enrolling qualified participants.

How do I join the focal segmental glomerulosclerosis clinical trial in Akron?

To join this clinical trial in Akron, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Akron clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Focal Segmental Glomerulosclerosis Clinical Trial in Akron, OH

About This Focal Segmental Glomerulosclerosis Study in Akron

This multicenter, prospective, single-arm clinical study will evaluate the probable benefit and safety of the LIPOSORBER® LA-15 System for the treatment of adult patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis, when the standard treatment options, including corticosteroid and/or calcineurin inhibitors treatments, have been unsuccessful or not well tolerated, and the patient has a GFR ≥ 45 ml/min/1.73m2, or the patient has post-renal transplant recurrence. Treatment for FSGS is considered unsuccessful if the patient is unresponsive to standard therapy (e.g., at least 8 weeks of corticosteroids) and fails to achieve complete or partial remission. A standard treatment is considered not well tolerated if the patient experiences severe side effects without providing an acceptable level of clinical benefit.

Sponsor: Kaneka Medical America LLC

Who Can Participate

Inclusion Criteria

A patient is deemed suitable for inclusion in the study if the patient has nephrotic syndrome associated with primary FSGS when: • Standard treatment options, including corticosteroid and/or calcineurin inhibitors, are unsuccessful or not well tolerated and the patient's glomerular filtration rate (GFR) ≥ 45 ml/min/1.73 m2. or • The patient is post renal transplantation.

Exclusion Criteria

General Exclusion Criteria

Patient is greater than 75 years of age at the start of the treatment period or less than 22

The patient is unwilling or unable to sign and date the informed consent

Pregnant, lactating, or planning to become pregnant prior to completing the study (Note: The safety of the use of LIPOSORBER® in pregnant women has not been studied. There may be unknown risks to an embryo/fetus. Sexually active women of childbearing potential should avoid pregnancy during the use of the LIPOSORBER device and throughout the study duration.)

Unable or unwilling to comply with the follow-up schedule

Simultaneously participating in another investigational drug or device study

Body weight \< 15 kg (33.1 lbs) Medical Exclusion Criteria

Currently being administered ACE inhibitors that cannot be withheld for at least 24 hours prior to each apheresis treatment (Note: The time period to withhold ACE inhibitors should be prolonged, if determined by the treating physician, considering each individual's renal function and the biological half-life of the ACE-inhibitor currently in use.)

Currently being administered antihypertensive drugs other than ACE inhibitors (e.g., ARBs) that cannot be withheld on the day of apheresis until after the procedure

Medical condition or disorder that would limit life expectancy to less than the primary clinical study endpoint or that may cause noncompliance with the study plan or confound the data analysis

Hypersensitivity to dextran sulfate, heparin, or ethylene oxide

Adequate anticoagulation cannot be achieved due to severe hemophilia, severe hemorrhage diathesis, severe gastrointestinal ulcers, or are recipients of vitamin K antagonist medications

Extracorporeal circulation therapy with LIPOSORBER® LA-15 System cannot be tolerated due to severe cardiac insufficiency, acute myocardial infarction, severe cardiac arrhythmia, acute apoplexy, severe uncontrollable hypertension, or severe uncontrollable hypotension Note: Severe uncontrollable hypotension/hypertension indicates the cases with systolic and/or diastolic blood pressure ≤ 5th percentile for age, gender, and height.

Cardiac impairments such as uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure, or valvular disease

Functional thyroid disease or liver abnormalities

Unresolved systemic or local infection that could affect the clinical study outcomes

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Akron?

Yes, this clinical trial (NCT04065438) has an active research site in Akron, OH that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Focal Segmental Glomerulosclerosis Treatment Options in Akron, OH

If you're searching for focal segmental glomerulosclerosis treatment options in Akron, OH, this clinical trial (NCT04065438) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Akron research site is actively enrolling participants for this clinical trial. You'll receive care from experienced focal segmental glomerulosclerosis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all focal segmental glomerulosclerosis clinical trials near you to find additional studies recruiting in your area.

Focal Segmental Glomerulosclerosis Clinical Trial in Akron, OH

Expert Care in Akron

IRB Approved

No-Cost Care

Apply for This Akron Location

Why Participate?

Simple Process