Focal Segmental GlomerulosclerosisFSGS pediatricNCT02235857
Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children
A study testing LIPOSORBER® LA-15 System in people with Focal Segmental Glomerulosclerosis, run by Kaneka Medical America LLC at 12 sites in United States.
Trial summary
Liposorber® LA-15 System is a blood purification therapy that selectively removes malignant lipoproteins including low density lipoprotein from circulating blood flow and rapidly reduces the plasma cholesterol level. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Focal Segmental Glomerulosclerosis
- What is being tested?
- LIPOSORBER® LA-15 System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 12 sitesUnited States
- Study dates
- 3 May 2015to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- A pediatric patient is deemed suitable for inclusion in the study if the patient has FSGS with a GFR ≥ 45 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.
- or
- Pediatric post renal transplant patients with nephrotic syndrome associated with primary FSGS.
Who cannot join
- General Exclusion Criteria
- Patient is greater than 21 years of age
- Parent or patient is unwilling or unable to sign and date the informed consent (Note: Only patients 18-21 years of age may sign the informed consent on their own behalf)
- 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 child bearing 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
Show all 17Show fewer
- 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., Angiotensin II receptor blockers (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
- Cardiac impairments such as uncontrolled arrhyth¬mia, 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
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 10 recruiting
- Recruiting
Akron Children's Hospital
Akron, Ohio, 44308
Rupesh Raina, MD, 330-543-8950, RRaina@chmca.org
Ann Pokelsek, BSN, RN,, 330-543-0702, apokelsek@akronchildrens.org
- Recruiting
University of North Carolina
Chapel Hill, North Carolina, 27599
Koyal Jain, MD
Anne Froment, (919) 445-2622, anne_froment@med.unc.edu
- Recruiting
Medical University of South Carolina Children's Hospital
Charleston, South Carolina, 29425
Katherine E Twombley, MD, 843-792-8904, twombley@musc.edu
- Recruiting
Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Alejandro Quiroga, MD, 616-267-2400
- Recruiting
Loma Linda University Children's Hospital
Loma Linda, California, 92354
Cheryl P Sanchez-Kazi, MD, 909-651-1904
- Recruiting
Cedars Sinai Medical Center
Los Angeles, California, 90048
Ananth S Karumanchi, 310-423-7608, SAnanth.Karumanchi@csmc.edu
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55454
Michelle Rheault, MD, 612-626-2922, rheau002@umn.edu
- Recruiting
Weill Cornell Medical Center / NewYork-Presbyterian
New York, New York, 10065
Eduardo M Perelstein, MD, 646-962-4324, emperels@med.cornell.edu
- Terminated
Nemours Children's Health
Orlando, Florida, 32827
- Recruiting
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
Joshua J Zaritsky, MD, 215-427-5190
- Withdrawn
Children's Hospital of Richmond at VCU
Richmond, Virginia, 23219
- Recruiting
Nemours/A.I. duPont Hospital for Children
Wilmington, Delaware, 19803
Joshua Zaritsky, MD PhD, 302-651-5527, joshua.zaritsky@nemours.org
About this study
Official title: Treatment of Drug-resistant Pediatric Primary Focal Segmental Glomerulosclerosis Using the Liposorber® LA-15 System
Liposorber® LA-15 System is a blood purification therapy that selectively removes malignant lipoproteins including low density lipoprotein from circulating blood flow and rapidly reduces the plasma cholesterol level. The system was originally developed for the treatment of patients with serious dyslipidemia such as familial hypercholesterolemia and then applied to improve the dyslipidemia, a common complication of nephrotic syndrome and found to bring about improvement not only with the dyslipidemic condition but the nephrotic condition (e.g, proteinuria and hypoproteinemia).
Although the definitive mechanism by which the system may relieve nephrotic syndrome is unknown, it has been recognized as one of alternative therapies for refractory nephrotic syndrome including focal segmental glomerulosclerosis (FSGS) in Japan and referred in the Guidelines for the Treatment of Nephrotic Syndrome endorsed by The Japanese Society of Nephrology.
This study is conducted as a post approval study imposed by Humanitarian Device Exemption (HDE) order to confirm the safety and efficacy of the Liposorber® LA-15 System in the treatment of drug-resistant pediatric primary FSGS.
- Conditions
- Focal Segmental Glomerulosclerosis
- Being tested
- LIPOSORBER® LA-15 System
- Keywords
- pediatric, renal transplantation, recurrence, drug-resistant
- Medical subject headings
- Glomerulosclerosis, Focal Segmental, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIPOSORBER® LA-15 SystemDevice
Also called LDL apheresis, LDL adsorption, dextran sulfate column
LIPOSORBER® LA-15 System is an extracorporeal blood purification system. Approximately 3 to 4 L of plasma is treated in a single treatment session and it takes 2 to 3 hours. Recommended frequency of the treatment is twice weekly for 3 weeks followed by once weekly for 6 weeks, thus it takes 9 weeks for a total of 12 treatment sessions.
| Study group | Role | What they receive |
|---|---|---|
| Liposorber® LA-15 System | Experimental | 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 3weeks and then once weekly for the following 6 weeks. Receives: Device: LIPOSORBER® LA-15 System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent of patients who show complete or partial remission
Measured: 1 month after the final treatment
the rate of device-related and procedure-related serious adverse events
Measured: During the period in which the apheresis procedures are administered and up to at the 1-month follow-up visit
Secondary outcomes (5)
Nephrotic Condition
Nephrotic condition defined as follows:
urine protein:creatinine ratio > 2.0 (g/g) with a first morning void urine sample
Measured: 1, 3, 6, 12, and 24 months after the final treatment
The percent of patients who obtain complete or partial remission
Measured: 3, 6, 12, and 24 months after the final treatment
Incidence of adverse events
The protocol indicates the standard treatment schedule as follows:
2 sessions weekly for the first 3 weeks followed by 1 session weekly for 6 weeks
Measured: From the initiation of the first apheresis session until the termination of the last (usually 12th) apheresis session, standad period of 9 weeks for a total of 12 aoheresis sessions
Incidence of adverse events and severe adverse events
Measured: From 1 months to 24 months after the final aphresis
Various laboratory values
Various laboratory values include Urine protein, Urine creatinine, Serum creatinine, Estimated glomerular filtration rate (eGFR), serum total protein, Serum albumin, Serum vitamin E, Hematocrit, Red blood cell, White blood cell, Platelet, Total cholesterol, LDL cholesterol, HDL cholesterol, Triglycerides, Serum soluble urokinase plasminogen activator receptor.
Measured: 1,3, 6, 12, and 24 months after the final apheresis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study start3 May 2015
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Focal Segmental GlomerulosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with focal segmental glomerulosclerosis treated by LIPOSORBER® LA-15 system
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaneka Medical America LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey I Silberzweig, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235857
- Sponsor's protocol ID
- KMA-FSGS-H120005
- Acronym
- FSGS pediatric
- Status last verified
- Aug 2026
- First submitted
- 6 Sep 2014
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Reidy K, Kaskel FJ. Pathophysiology of focal segmental glomerulosclerosis. Pediatr Nephrol. 2007 Mar;22(3):350-4. doi: 10.1007/s00467-006-0357-2. Epub 2007 Jan 10.
PubMed 17216262Franceschini N, North KE, Kopp JB, McKenzie L, Winkler C. NPHS2 gene, nephrotic syndrome and focal segmental glomerulosclerosis: a HuGE review. Genet Med. 2006 Feb;8(2):63-75. doi: 10.1097/01.gim.0000200947.09626.1c.
PubMed 16481888Korbet SM. The treatment of primary focal segmental glomerulosclerosis. Ren Fail. 2000 Nov;22(6):685-96. doi: 10.1081/jdi-100101956.
PubMed 11104158Tarshish P, Tobin JN, Bernstein J, Edelmann CM Jr. Cyclophosphamide does not benefit patients with focal segmental glomerulosclerosis. A report of the International Study of Kidney Disease in Children. Pediatr Nephrol. 1996 Oct;10(5):590-3. doi: 10.1007/s004670050167.
PubMed 8897562Fine RN. Recurrence of nephrotic syndrome/focal segmental glomerulosclerosis following renal transplantation in children. Pediatr Nephrol. 2007 Apr;22(4):496-502. doi: 10.1007/s00467-006-0361-6. Epub 2006 Dec 21.
PubMed 17186280Schwartz GJ, Munoz A, Schneider MF, Mak RH, Kaskel F, Warady BA, Furth SL. New equations to estimate GFR in children with CKD. J Am Soc Nephrol. 2009 Mar;20(3):629-37. doi: 10.1681/ASN.2008030287. Epub 2009 Jan 21.
PubMed 19158356Trachtman H, Vento S, Gipson D, Wickman L, Gassman J, Joy M, Savin V, Somers M, Pinsk M, Greene T. Novel therapies for resistant focal segmental glomerulosclerosis (FONT) phase II clinical trial: study design. BMC Nephrol. 2011 Feb 10;12:8. doi: 10.1186/1471-2369-12-8.
PubMed 21310077Meliambro K, He JC, Campbell KN. Podocyte-targeted therapies - progress and future directions. Nat Rev Nephrol. 2024 Oct;20(10):643-658. doi: 10.1038/s41581-024-00843-z. Epub 2024 May 9.
PubMed 38724717
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Drug-resistant Pediatric Primary Focal Segmental Glomerulosclerosis Using the Liposorber® LA-15 System
- ClinicalTrials.gov ID
- NCT02235857
- Acronym / sponsor ID
- FSGS pediatric / KMA-FSGS-H120005
- Conditions
- Focal Segmental Glomerulosclerosis
- Keywords
- pediatric, renal transplantation, recurrence, drug-resistant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Kaneka Medical America LLCIndustry (pharma, biotech, devices)
- Study start
- 3 May 2015 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 10 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Liposorber® LA-15 System is a blood purification therapy that selectively removes malignant lipoproteins including low density lipoprotein from circulating blood flow and rapidly reduces the plasma cholesterol level. The system was originally developed for the treatment of patients with serious dyslipidemia such as familial hypercholesterolemia and then applied to improve the dyslipidemia, a common complication of nephrotic syndrome and found to bring about improvement not only with the dyslipidemic condition but the nephrotic condition (e.g, proteinuria and hypoproteinemia).
Although the definitive mechanism by which the system may relieve nephrotic syndrome is unknown, it has been recognized as one of alternative therapies for refractory nephrotic syndrome including focal segmental glomerulosclerosis (FSGS) in Japan and referred in the Guidelines for the Treatment of Nephrotic Syndrome endorsed by The Japanese Society of Nephrology.
This study is conducted as a post approval study imposed by Humanitarian Device Exemption (HDE) order to confirm the safety and efficacy of the Liposorber® LA-15 System in the treatment of drug-resistant pediatric primary FSGS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with focal segmental glomerulosclerosis treated by LIPOSORBER® LA-15 system
| Arm | Type | Receives |
|---|---|---|
| Liposorber® LA-15 System | Experimental | Device: LIPOSORBER® LA-15 SystemAll 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 3weeks and then once weekly for the following 6 weeks. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- A pediatric patient is deemed suitable for inclusion in the study if the patient has FSGS with a GFR ≥ 45 ml/min/1.73 m 2 and any of the following:
- or
- Pediatric post renal transplant patients with nephrotic syndrome associated with primary FSGS.
Key exclusion criteria (17 listed)
- General Exclusion Criteria
- Medical Exclusion Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIPOSORBER® LA-15 SystemAlso: LDL apheresis, LDL adsorption, dextran sulfate columnLIPOSORBER® LA-15 System is an extracorporeal blood purification system. Approximately 3 to 4 L of plasma is treated in a single treatment session and it takes 2 to 3 hours. Recommended frequency of the treatment is twice weekly for 3 weeks followed by once weekly for 6 weeks, thus it takes 9 weeks for a total of 12 treatment sessions. | Device | Liposorber® LA-15 System |
Primary outcome
The percent of patients who show complete or partial remission
Time frame: 1 month after the final treatment
the rate of device-related and procedure-related serious adverse events
Time frame: During the period in which the apheresis procedures are administered and up to at the 1-month follow-up visit
5 secondary outcomes
Nephrotic Condition
Time frame: 1, 3, 6, 12, and 24 months after the final treatment
The percent of patients who obtain complete or partial remission
Time frame: 3, 6, 12, and 24 months after the final treatment
Incidence of adverse events
Time frame: From the initiation of the first apheresis session until the termination of the last (usually 12th) apheresis session, standad period of 9 weeks for a total of 12 aoheresis sessions
Incidence of adverse events and severe adverse events
Time frame: From 1 months to 24 months after the final aphresis
Various laboratory values
Time frame: 1,3, 6, 12, and 24 months after the final apheresis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Background: PubMed 17216262Reidy K, Kaskel FJ. Pathophysiology of focal segmental glomerulosclerosis. Pediatr Nephrol. 2007 Mar;22(3):350-4. doi: 10.1007/s00467-006-0357-2. Epub 2007 Jan 10.
- Background: PubMed 16481888Franceschini N, North KE, Kopp JB, McKenzie L, Winkler C. NPHS2 gene, nephrotic syndrome and focal segmental glomerulosclerosis: a HuGE review. Genet Med. 2006 Feb;8(2):63-75. doi: 10.1097/01.gim.0000200947.09626.1c.
- Background: PubMed 11104158Korbet SM. The treatment of primary focal segmental glomerulosclerosis. Ren Fail. 2000 Nov;22(6):685-96. doi: 10.1081/jdi-100101956.
- Background: PubMed 8897562Tarshish P, Tobin JN, Bernstein J, Edelmann CM Jr. Cyclophosphamide does not benefit patients with focal segmental glomerulosclerosis. A report of the International Study of Kidney Disease in Children. Pediatr Nephrol. 1996 Oct;10(5):590-3. doi: 10.1007/s004670050167.
- Background: PubMed 17186280Fine RN. Recurrence of nephrotic syndrome/focal segmental glomerulosclerosis following renal transplantation in children. Pediatr Nephrol. 2007 Apr;22(4):496-502. doi: 10.1007/s00467-006-0361-6. Epub 2006 Dec 21.
- Background: PubMed 19158356Schwartz GJ, Munoz A, Schneider MF, Mak RH, Kaskel F, Warady BA, Furth SL. New equations to estimate GFR in children with CKD. J Am Soc Nephrol. 2009 Mar;20(3):629-37. doi: 10.1681/ASN.2008030287. Epub 2009 Jan 21.
- Background: PubMed 21310077Trachtman H, Vento S, Gipson D, Wickman L, Gassman J, Joy M, Savin V, Somers M, Pinsk M, Greene T. Novel therapies for resistant focal segmental glomerulosclerosis (FONT) phase II clinical trial: study design. BMC Nephrol. 2011 Feb 10;12:8. doi: 10.1186/1471-2369-12-8.
- Derived from this study: PubMed 38724717Meliambro K, He JC, Campbell KN. Podocyte-targeted therapies - progress and future directions. Nat Rev Nephrol. 2024 Oct;20(10):643-658. doi: 10.1038/s41581-024-00843-z. Epub 2024 May 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeffrey I Silberzweig, MD principal investigator
Weill Medical College of Cornell University
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIPOSORBER® LA-15 System in people with Focal Segmental Glomerulosclerosis, run by Kaneka Medical America LLC at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayaka Kitamura (+81-74431813933, Ayaka.Kitamura1@kaneka.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percent of patients who show complete or partial remission (time frame: 1 month after the final treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02235857, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.