Focal Segmental GlomerulosclerosisFSGSALLAGENCT04065438
Post Approval Study for Treatment of Drug-resistant Adult and Pediatric Primary FSGS Using the LIPOSORBER® LA-15 System
A study testing LIPOSORBER® LA-15 in people with Focal Segmental Glomerulosclerosis, run by Kaneka Medical America LLC at 10 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Focal Segmental Glomerulosclerosis
- What is being tested?
- LIPOSORBER® LA-15
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 10 sitesUnited States
- Study dates
- 1 Jan 2020to 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 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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., 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Akron Children's Hospital
Akron, Ohio, 44308
Rupesh Raina, MD, 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
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Linda Walker, 843-792-6109, walkerlp@musc.edu
- Recruiting
Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Alejandro Quiroga, MD
- Recruiting
Loma Linda University Children's Hospital
Loma Linda, California, 92354
Cheryl P Sanchez-Kazi, MD
- Recruiting
Loma Linda University Hospital
Loma Linda, California, 92354
Amir Abdipour, MD
Daisy Sekly, DSekly@llu.edu
- Recruiting
Weill Cornell Medicine / NewYork-Presbyterian
New York, New York, 10065
Eduardo M Perelstein, MD
- Recruiting
Children's Hospital of Richmond at VCU
Richmond, Virginia, 23298
Megan M Lo, MD
- Recruiting
Nemours/Alfred I DuPont Hospital for Children
Wilmington, Delaware, 19803
Joshua J Zaritsly, MD, 302-651-5527, joshua.zaritsky@nemours.org
About this study
Official title: Treatment of Drug-resistant Adult and Pediatrc Primary Focal Segmental Glomerulosclerosis and Post -Transplant Recurrence Using the LIPOSORBER® LA-15 System
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.
Read the detailed description
This study will enroll up to 35 adult patients at 3-10 clinical sites. The duration of the treatment phase of the study will take approximately 9 weeks for a total of 12 apheresis treatments with the LIPOSORBER® LA-15 System; the treatments will be given twice weekly for 3 weeks followed by once weekly for 6 weeks. Patients will undergo follow-up at 1, 3, 6, 12, and 24 months after the final apheresis treatment.
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 primary FSGS and post Transplant recurrence.
- Conditions
- Focal Segmental Glomerulosclerosis
- Being tested
- LIPOSORBER® LA-15
- Keywords
- FSGS, Liposorber
- Medical subject headings
- Glomerulosclerosis, Focal Segmental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIPOSORBER® LA-15Device
LIPOSORBER® LA-15 is a blood purification therapy; selectively removes apoprotein B-containing lipoproteins such as LDL from circulating blood and rapidly reduces the plasma cholesterol level. It was originally developed for prevention of coronary atherosclerosis progression in patients with serious hyperlipidemia such as familial hypercholesterolemia.
In the late 1980's, LDL-A was used to improve dyslipidemia in Nephrotic Syndrome, initially to prevent organ damage. LDL-A was found to improve both the dyslipidemic condition and clinical symptoms (proteinuria and hypoproteinemia).
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and probable benefit of the LIPOSORBER® LA-15 System in relieving nephrotic syndrome associated with primary FSGS at 1 month after the final apheresis treatment. partial remission at 1 month after the final apheresis treatment.
The primary probable benefit endpoint will be assessed by calculating the percent reduction in Up/c values at screening and at 1 month after the final apheresis.
Measured: 1 month after the final Apheresis treatment.
Secondary outcomes (1)
Nephrotic condition at 1, 3, 6, 12, and 24 months after the final apheresis treatment, including the percentage of patients who obtain complete or partial remission at 3, 6, 12, and 24 months.
Nephrotic condition will be evaluated in following categories, CR (complete remission), PR (partial remission), or NS (nephrotic syndrome).
Measured: 1, 3, 6, 12, and 24 months after the final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start1 Jan 2020
- 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 (1)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
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065438
- Sponsor's protocol ID
- KMA-FSGS-H170002
- Acronym
- FSGSALLAGE
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2019
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Meliambro 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 Adult and Pediatrc Primary Focal Segmental Glomerulosclerosis and Post -Transplant Recurrence Using the LIPOSORBER® LA-15 System
- ClinicalTrials.gov ID
- NCT04065438
- Acronym / sponsor ID
- FSGSALLAGE / KMA-FSGS-H170002
- Conditions
- Focal Segmental Glomerulosclerosis
- Keywords
- FSGS, Liposorber
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Kaneka Medical America LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 22 Aug 2019 (actual)
- 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.
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.
Detailed description
This study will enroll up to 35 adult patients at 3-10 clinical sites. The duration of the treatment phase of the study will take approximately 9 weeks for a total of 12 apheresis treatments with the LIPOSORBER® LA-15 System; the treatments will be given twice weekly for 3 weeks followed by once weekly for 6 weeks. Patients will undergo follow-up at 1, 3, 6, 12, and 24 months after the final apheresis treatment.
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 primary FSGS and post Transplant recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LIPOSORBER® LA-15 System | Experimental | Device: LIPOSORBER® LA-15All 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 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
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-15LIPOSORBER® LA-15 is a blood purification therapy; selectively removes apoprotein B-containing lipoproteins such as LDL from circulating blood and rapidly reduces the plasma cholesterol level. It was originally developed for prevention of coronary atherosclerosis progression in patients with serious hyperlipidemia such as familial hypercholesterolemia. In the late 1980's, LDL-A was used to improve dyslipidemia in Nephrotic Syndrome, initially to prevent organ damage. LDL-A was found to improve both the dyslipidemic condition and clinical symptoms (proteinuria and hypoproteinemia). | Device | LIPOSORBER® LA-15 System |
Primary outcome
Evaluate the safety and probable benefit of the LIPOSORBER® LA-15 System in relieving nephrotic syndrome associated with primary FSGS at 1 month after the final apheresis treatment. partial remission at 1 month after the final apheresis treatment.
Time frame: 1 month after the final Apheresis treatment.
The primary probable benefit endpoint will be assessed by calculating the percent reduction in Up/c values at screening and at 1 month after the final apheresis.
1 secondary outcome
Nephrotic condition at 1, 3, 6, 12, and 24 months after the final apheresis treatment, including the percentage of patients who obtain complete or partial remission at 3, 6, 12, and 24 months.
Time frame: 1, 3, 6, 12, and 24 months after the final treatment
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.
- 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.
- Individual participant dataSharing planned: No
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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.
10 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 in people with Focal Segmental Glomerulosclerosis, run by Kaneka Medical America LLC at 10 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 4 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 10 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?
Evaluate the safety and probable benefit of the LIPOSORBER® LA-15 System in relieving nephrotic syndrome associated with primary FSGS at 1 month after the final apheresis treatment. partial remission at 1 month after the final apheresis treatment. (time frame: 1 month after the final Apheresis treatment.). 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 NCT04065438, which also lists 1 linked publication.
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.