Description: This is a post approval study, working to confirm the safety and efficacy of the Liposorber® LA-15 System in the treatment of drug-resistant pediatric primary FSGS.
|Condition||Focal Segmental Glomerulosclerosis|
|Start Date||March 2015|
|Intervention||Liposorber® LA-15 System|
|Estimated Enrollment||35 participants|
|Age||Up to 21 years|
|Accepts Healthy Volunteers||No|
- A pediatric patient is deemed suitable for inclusion in the study if the patient has FSGS with a GFR ≥ 60 ml/min/1.73 m 2 and any of the following:
- Refractory nephrotic syndrome in which standard treatment options are unsuccessful (i.e., patient is unresponsive to standard corticosteroid and/or calcineurin inhibitor therapy for at least 8 weeks resulting in failure to achieve complete or partial remission);
- Refractory nephrotic syndrome in which standard treatment options are not well tolerated (i.e., patients intolerant to standard therapies due to severe side effects that negatively affect quality of life without providing an acceptable level of clinical benefit);
- Refractory or recurrent nephrotic syndrome in which standard therapy is contraindicated
- Pediatric post renal transplant patients with nephrotic syndrome associated with primary FSGS.
- Patient is greater than 21 years of age
- Parent or patient is unwilling or unable to sign and date the informed consent
- Pregnant, lactating, or planning to become pregnant prior to completing the study
- Unable or unwilling to comply with the follow-up schedule
- Simultaneously participating in another investigational drug or device study
- Body weight less than 40 pounds
- Currently being administered ACE inhibitors that cannot be withheld for at least 24 hours prior to each treatment
- Currently being administered antihypertensive drugs other than ACE inhibitors
- 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
- Severe hemophilia, severe hemorrhage diathesis, severe gastrointestinal ulcers, or are recipients of vitamin K antagonist medications
- Extracorporeal circulation therapy
- Cardiac impairments such as uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure, or valvular disease
- Thyroid disease or liver abnormalities
- Unresolved systemic or local infection
Frequently Asked Questions (FAQs):
- Does this study require me to stop taking other medications?
- Yes, participants cannot be taking ACE inhibitors or any other antihypertensive drugs.
- Is there a placebo used in this study?
- No, all participants will receive the intervention.
- What would I/my child have to do if involved in this study?
All study patients who meet the study eligibility criteria will undergo the extracorporeal treatment using Liposorber® LA-15 System. The participants are to be treated with the system twice weekly for the 3 weeks and then once weekly for the following 6 weeks.
Who can participate?
Patients diagnosed with FSGS up to 21 years of age.
Who do I contact with general questions?
or visit www.liposorber.com
Where can I participate?
The following is a list of study sites in the US and Canada with contact information for the corresponding principal investigators:
Contact Information by Trial Site
|State||City||Site Name||Contact Information|
|DE||Wilmington||Nemours Hospital for Children||Joshua Zaritsky, MD, PhD: 302-651-5527, firstname.lastname@example.org|
|FL||Orlando||Nemours Children's Hospital||Robert S Mathias, MD: 407-650-7715, Robert.Mathias@nemours.org; Charmaine Garcia: 407-567-6204, email@example.com|
|OH||Akron||Akron Children's Hospital||Rupesh Raina, MD: 330-543-8950, firstname.lastname@example.org|