Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2026-02-13 @ 12:56 AM
Study NCT ID:
NCT02235857
Status:
RECRUITING
Last Update Posted:
2025-04-30
First Post:
2014-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005923', 'term': 'Glomerulosclerosis, Focal Segmental'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients with focal segmental glomerulosclerosis treated by LIPOSORBER® LA-15 system'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-05-03', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2028-07-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2014-09-06', 'studyFirstSubmitQcDate': '2014-09-09', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-05-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percent of patients who show complete or partial remission', 'timeFrame': '1 month after the final treatment'}, {'measure': 'the rate of device-related and procedure-related serious adverse events', 'timeFrame': 'During the period in which the apheresis procedures are administered and up to at the 1-month follow-up visit'}], 'secondaryOutcomes': [{'measure': 'Nephrotic Condition', 'timeFrame': '1, 3, 6, 12, and 24 months after the final treatment', 'description': 'Nephrotic condition defined as follows:\n\nurine protein:creatinine ratio \\> 2.0 (g/g) with a first morning void urine sample'}, {'measure': 'The percent of patients who obtain complete or partial remission', 'timeFrame': '3, 6, 12, and 24 months after the final treatment'}, {'measure': 'Incidence of adverse events', 'timeFrame': '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', 'description': 'The protocol indicates the standard treatment schedule as follows:\n\n2 sessions weekly for the first 3 weeks followed by 1 session weekly for 6 weeks'}, {'measure': 'Incidence of adverse events and severe adverse events', 'timeFrame': 'From 1 months to 24 months after the final aphresis'}, {'measure': 'Various laboratory values', 'timeFrame': '1,3, 6, 12, and 24 months after the final apheresis', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['pediatric, renal transplantation, recurrence, drug-resistant'], 'conditions': ['Focal Segmental Glomerulosclerosis']}, 'referencesModule': {'references': [{'pmid': '17216262', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16481888', 'type': 'BACKGROUND', 'citation': 'Franceschini 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.'}, {'pmid': '11104158', 'type': 'BACKGROUND', 'citation': 'Korbet SM. The treatment of primary focal segmental glomerulosclerosis. Ren Fail. 2000 Nov;22(6):685-96. doi: 10.1081/jdi-100101956.'}, {'pmid': '8897562', 'type': 'BACKGROUND', 'citation': 'Tarshish 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.'}, {'pmid': '17186280', 'type': 'BACKGROUND', 'citation': 'Fine 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.'}, {'pmid': '19158356', 'type': 'BACKGROUND', 'citation': 'Schwartz 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.'}, {'pmid': '21310077', 'type': 'BACKGROUND', 'citation': 'Trachtman 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.'}]}, 'descriptionModule': {'briefSummary': '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).\n\nAlthough 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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:\n\n * 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);\n * 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);\n * Refractory or recurrent nephrotic syndrome in which standard therapy is contraindicated.\n\nor\n\n\\- Pediatric post renal transplant patients with nephrotic syndrome associated with primary FSGS.\n\nExclusion Criteria:\n\n* General Exclusion Criteria\n\n * Patient is greater than 21 years of age\n * 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)\n * 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.)\n * Unable or unwilling to comply with the follow-up schedule\n * Simultaneously participating in another investigational drug or device study\n * Body weight \\< 15 kg (33.1 lbs)\n* Medical Exclusion Criteria\n\n * 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.)\n * 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\n * 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\n * Hypersensitivity to dextran sulfate, heparin, or ethylene oxide\n * Adequate anticoagulation cannot be achieved due to severe hemophilia, severe hemorrhage diathesis, severe gastrointestinal ulcers, or are recipients of vitamin K antagonist medications\n * 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\n * Cardiac impairments such as uncontrolled arrhyth¬mia, unstable angina, decompensated congestive heart failure, or valvular disease\n * Functional thyroid disease or liver abnormalities\n * Unresolved systemic or local infection that could affect the clinical study outcomes"}, 'identificationModule': {'nctId': 'NCT02235857', 'acronym': 'FSGS pediatric', 'briefTitle': 'Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kaneka Medical America LLC'}, 'officialTitle': 'Treatment of Drug-resistant Pediatric Primary Focal Segmental Glomerulosclerosis Using the Liposorber® LA-15 System', 'orgStudyIdInfo': {'id': 'KMA-FSGS-H120005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liposorber® LA-15 System', 'description': '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.', 'interventionNames': ['Device: LIPOSORBER® LA-15 System']}], 'interventions': [{'name': 'LIPOSORBER® LA-15 System', 'type': 'DEVICE', 'otherNames': ['LDL apheresis', 'LDL adsorption', 'dextran sulfate column'], 'description': '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.', 'armGroupLabels': ['Liposorber® LA-15 System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cheryl P Sanchez-Kazi, MD', 'role': 'CONTACT', 'phone': '909-651-1904'}], 'facility': "Loma Linda University Children's Hospital", 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ananth S Karumanchi', 'role': 'CONTACT', 'email': 'SAnanth.Karumanchi@csmc.edu', 'phone': '310-423-7608'}], 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '19803', 'city': 'Wilmington', 'state': 'Delaware', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joshua Zaritsky, MD PhD', 'role': 'CONTACT', 'email': 'joshua.zaritsky@nemours.org', 'phone': '302-651-5527'}], 'facility': 'Nemours/A.I. duPont Hospital for Children', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '32827', 'city': 'Orlando', 'state': 'Florida', 'status': 'TERMINATED', 'country': 'United States', 'facility': "Nemours Children's Health", 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alejandro Quiroga, MD', 'role': 'CONTACT', 'phone': '616-267-2400'}], 'facility': "Helen DeVos Children's Hospital", 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '55454', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michelle Rheault, MD', 'role': 'CONTACT', 'email': 'rheau002@umn.edu', 'phone': '612-626-2922'}], 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eduardo M Perelstein, MD', 'role': 'CONTACT', 'email': 'emperels@med.cornell.edu', 'phone': '646-962-4324'}], 'facility': 'Weill Cornell Medical Center / NewYork-Presbyterian', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Koyal Jain, MD', 'role': 'CONTACT'}, {'name': 'Anne Froment', 'role': 'CONTACT', 'email': 'anne_froment@med.unc.edu', 'phone': '(919) 445-2622'}], 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '44308', 'city': 'Akron', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rupesh Raina, MD', 'role': 'CONTACT', 'email': 'RRaina@chmca.org', 'phone': '330-543-8950'}, {'name': 'Ann Pokelsek, BSN, RN,', 'role': 'CONTACT', 'email': 'apokelsek@akronchildrens.org', 'phone': '330-543-0702'}], 'facility': "Akron Children's Hospital", 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '19134', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joshua J Zaritsky, MD', 'role': 'CONTACT', 'phone': '215-427-5190'}], 'facility': "St. Christopher's Hospital for Children", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katherine E Twombley, MD', 'role': 'CONTACT', 'email': 'twombley@musc.edu', 'phone': '843-792-8904'}], 'facility': "Medical University of South Carolina Children's Hospital", 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '23219', 'city': 'Richmond', 'state': 'Virginia', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': "Children's Hospital of Richmond at VCU", 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'centralContacts': [{'name': 'Ayaka Kitamura', 'role': 'CONTACT', 'email': 'Ayaka.Kitamura1@kaneka.co.jp', 'phone': '+81-74431813933'}], 'overallOfficials': [{'name': 'Jeffrey I Silberzweig, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaneka Medical America LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}