Study Details
Obinutuzumab: A Study Drug for Childhood-Onset Idiopathic Nephrotic Syndrome (INShore study)
(IRB#: IRB_00161524)
Idiopathic Nephrotic Syndrome is a type of kidney disease. This condition may require many hospital visits, new medications, and relapses. Obinutuzumab is a study drug to help improve the lives of children and young people with this issue and their families. Research is needed to learn how safe and effective Obinutuzumab is when compared to a currently used common drug. The information we gain may aid future patients.
- All genders
- All Ages
- Volunteers with special conditions
- In Person
- Paid
Who can participate?
Gender: All genders
Age: All Ages
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria
- Ages 2 to 25 years old
- Children with frequent relapsing nephrotic syndrome (FRNS) must have two or more relapses within 6 months or four or more relapses in 12 months of having INS
- Children with steroid dependent nephrotic syndrome (SDNS) must have had two relapses in a row during therapy with types of oral corticosteroid medications or within 15 days of stopping oral corticosteroids
- Have had at least one relapse in 6 months or be at higher risk before participation
- Must be in complete remission at time of participation
Exclusion Criteria
- Pregnant, breastfeeding, or female and male participants unwilling to use specific birth control
- Secondary nephrotic syndrome such as reflux nephropathy
- History of steroid-resistant nephrotic syndrome or genetic defects caused by nephrotic syndrome
- Current active or history of alcohol or drug abuse
- Active infection or history of serious health issues such as cancer or tuberculosis
Will I be paid for my time?
Yes
IRB#: IRB_00161524
PI: Raoul Nelson
Department: PEDIATRICS
Approval Date: 2023-06-21 06:00:00
Specialties: Pediatric Nephrology