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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.

I AM INTERESTED

  • 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

For more information contact:

Nick Knight

nick.knight@hsc.utah.edu

  801-581-8218

IRB#: IRB_00161524

PI: Raoul Nelson

Department: PEDIATRICS

Approval Date: 2023-06-21 06:00:00

Specialties: Pediatric Nephrology

Last Updated: 6/8/23