Condition: Focal Segmental Glomerulosclerosis · Sponsor: Kaneka Medical America LLC
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.
This description comes directly from the study's public registry record.
Ayaka Kitamura · +81-74431813933 · Ayaka.Kitamura1@kaneka.co.jp
Always discuss trial participation with your own doctor first.
| Loma Linda University Children's Hospital | Loma Linda, California, United States | Recruiting |
| Loma Linda University Hospital | Loma Linda, California, United States | Recruiting |
| Nemours/Alfred I DuPont Hospital for Children | Wilmington, Delaware, United States | Recruiting |
| Helen DeVos Children's Hospital | Grand Rapids, Michigan, United States | Recruiting |
| Weill Cornell Medicine / NewYork-Presbyterian | New York, New York, United States | Recruiting |
| University of North Carolina | Chapel Hill, North Carolina, United States | Recruiting |
| Akron Children's Hospital | Akron, Ohio, United States | Recruiting |
| Medical University of South Carolina Children's Hospital | Charleston, South Carolina, United States | Recruiting |
| Medical University of South Carolina | Charleston, South Carolina, United States | Recruiting |
| Children's Hospital of Richmond at VCU | Richmond, Virginia, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT04065438