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Abatacept for Nephrotic Syndrome (IM101566) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if abatacept can decrease the amount of protein in your child's urine and improve his/her kidney disease beyond the treatment your child has gotten or is already getting.

What is the Condition Being Studied?

Nephrotic Syndrome

Who Can Participate in the Study?

To be in this study, your child must be:
- Aged 6 years or older.
- Have treatment resistant nephrotic syndrome caused by kidney failure or kidney disease.
-Take medicine to help relax blood vessels or medicine to help narrow blood vessels.

Age Group
Adults, Children

What is Involved?

This study is divided into two periods.
If you decide to be part of this study:

During period 1 your child will:
Be randomized, like the flip of a coin, to first get either:
- The study drug Abatacept
- Placebo (salt water) for four months

During period 2:
Depending on what your child received during period 1, your child will switch to get either the study drug or placebo for another 4 months.  

Study Details

Full Title
A Phase II Randomized, Placebo-Controlled, Double-Blind, Parallel Arms, Pilot Study to Evaluate the Efficacy and Safety of Intravenous Abatacept in Treatment Resistant Nephrotic Syndrome (Focal Segmental Glomerulosclerosis/ Minimal Change
Principal Investigator
Pediatric Nephrologist
Protocol Number
IRB:PRO00071182
NCT:NCT02592798
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698