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Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children

Study acronym: FSGS pediatric
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 4 months later May 3, 2026 → Sep 30, 2027
See other at-risk trials from Kaneka Medical America LLC

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from May 3, 2026 to Sep 30, 2027
    • Study completion pushed from Jul 3, 2028 to Sep 30, 2029
    v13
  2. 3 versions Re-verified since Oct 7, 2024, no change to tracked fieldsv10-v12
  3. Primary completion date: Oct 2022 to May 3, 2026
    • Start date: Mar 2015 to May 3, 2015
    • Study completion date: Oct 2024 to Jul 3, 2028
    v9
  4. Study sites: 7 to 12v8
  5. Study sites revised (7)
    • Eligibility criteria expanded, about 1 word
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Site contacts updated at 1 of 7 sitesv6
  2. Primary completion date: Oct 2018 to Oct 2022
    • Study sites: 3 to 7
    • Study completion date: Oct 2020 to Oct 2024
    • Interventions: Liposorber® LA-15 System (Device) to LIPOSORBER® LA-15 System (Device)
    v5
  3. Eligibility criteria revisedv4
  4. Study sites revised (3)v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Oct 2014 to Mar 2015
    • Study sites: 1 to 3
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02235857
Lead Sponsor Kaneka Medical America LLC
Conditions
(from sponsor)		 Focal Segmental Glomerulosclerosis
Related terms Glomerulosclerosis, Focal Segmental, Recurrence
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov