Medical device study for patients with a rare kidney disease (Focal Segmental Glomerulosclerosis)
Full IRB Study Title:
Treatment of Drug-Resistant Pediatric Focal Segmental Glomerulosclerosis Using the Liposorber ® LA-15 System
IRB Study ID: 150111
This study is evaluating a new treatment for children with a rare kidney disease resulting from scar tissue in the kidney’s filtering system (the glomerulus). This part of the kidneys helps get rid of harmful waste materials in blood. If this filtering system doesn’t work properly, it may lead to kidney disease or even failure. The therapy we’re testing, the Liposorber LA-15 System, is a blood processing device that removes certain lipoproteins (known as “bad” cholesterol) from the patient’s blood. The device was first used in the U.S. to treat people whose very high cholesterol put them at significant risk for heart disease. We expect it will likely benefit children with this kidney filtering defect.
Study Sponsor:
Kaneka Pharma America, LLC
We are currently recruiting
If you are interested in this study or have questions about your child's eligibility, please contact:
Rebecca D. Considine Research Institute, 330-543-3193 or email research@akronchildrens.org
Who May Qualify:
- Pediatric patients with nephrotic syndrome associated with primary Focal Segmental Glomerulosclerosis (FSGS)
- Standard treatment options have been unsuccessful or not well tolerated
- The patient has a glomerular filtration rate (GFR) ≥ 60 ml/min/1.73m2
- OR- the patient has had a kidney transplant and the FSGS has returned
Who Does NOT Qualify:
- Patient is older than 21 years of age
- Body weight < 21 kg (46 lbs)
- Pregnant, lactating, or planning to become pregnant prior to completing the study
Lead Investigator
Rupesh Raina, MD, FACP, FAAP
Pediatric Nephrologist
Pediatric NephrologyPediatric Hypertension ClinicKidney Stone Clinic
