Offered by: Nemours
Location: Orlando, Fla.
A Phase II Study to Evaluate the Efficacy & Safety of IV Abatacept in Treatment Resistant FSGS/MCD
What is the trial about?
The purpose of this study is to see if the investigational study drug, Abatacept, can reduce the amount of protein in your child’s urine and improve your child’s kidney disease more than the treatment he or she has received or is already receiving.
Who can participate?
Males and Females greater than or equal to six years of age, diagnosed with Treatment Resistant Nephrotic Syndrome (TRNS) may be eligible to take part in this study.
What is involved?
FSGS/MCD — Focal Segmental Glomerulosclerosis/Minimal Change Disease - Abatacept - Renal for Males and Females greater than or equal to six years of age, diagnosed with Treatment Resistant Nephrotic Syndrome (TRNS)
(FSGS) Focal Segmental Glomerulosclerosis is a cause of nephrotic syndrome in children and adolescents, as well as a leading cause of kidney failure in adults. It is also known as "focal glomerular sclerosis" or "focal nodular glomerulosclerosis". It accounts for about a sixth of the cases of nephrotic syndrome.
(MCD) Minimal Change Disease is the most common cause of Nephrotic Syndrome in children — almost 85 percent of children with Nephrotic Syndrome symptoms have MCD. As a result, the term “Nephrotic Syndrome” is often used interchangeably with MCD. The diagnosis of MCD is given when the kidney biopsy reveals little or no change to the glomeruli or the surrounding kidney tissue. Tiny drops of a fatty substance may be present, but no scarring is seen within the kidney.
Participation will last about 21 months, and there will be about 27 visits in total. The frequency of visits varies from weekly to monthly.
Blood will be drawn at most of the study visits. Other procedures required for participation include: vital signs, physical exam, chest x-ray, tuberculosis screening, urine testing, questionnaires, medication and medical history review and intravenous infusion of the study drug.
Contact Nemours Clinical Trials
Trial Name: A Phase II Study to Evaluate the Efficacy & Safety of IV Abatacept in Treatment Resistant FSGS/MCD