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Post Approval Study for Treatment of Drug-resistant Adult and Pediatric Primary FSGS Using the LIPOSORBER® LA-15 System

Study acronym: FSGSALLAGE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 5 months later Apr 1, 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 Apr 1, 2026 to Sep 30, 2027
    • Study completion pushed from Jun 1, 2028 to Sep 30, 2029
    v13
  2. Re-verified, no change to tracked fieldsv12
  3. Secondary endpoints: details revised at 1 of 1 entryv11
  4. Primary completion date: Apr 1, 2023 to Apr 1, 2026
    • Study completion date: Jun 1, 2025 to Jun 1, 2028
    • Secondary endpoints: details revised at 1 of 1 entry
    v10
  5. Study title expanded, about 2 wordsv9
Show 7 earlier versionsHide 7 earlier versions
  1. Re-verified, no change to tracked fieldsv8
  2. Eligibility criteria expanded, about 1 wordv7
  3. Study sites: 3 to 10v6
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 2 to 3
    v5
  5. Study sites: 0 to 2v4
  6. 2 versions Re-verified since Aug 21, 2019, no change to tracked fieldsv2-v3
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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.
Trial Details
NCT Number NCT04065438
Lead Sponsor Kaneka Medical America LLC
Conditions
(from sponsor)		 Focal Segmental Glomerulosclerosis
Related terms Glomerulosclerosis, Focal Segmental
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov