At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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 Disease)
In Brief
A Phase 2 clinical trial evaluating Abatacept, Normal Saline, and 1 other intervention for Nephrotic Syndrome and 2 related conditions. Completed, enrolled 36 participants across 27 sites.
Detailed Summary
The purpose of this study is evaluate if abatacept is effective and safe in decreasing the level of protein loss in the urine in patients with excessive loss of protein in the urine (nephrotic syndrome) due to either focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD). Candidates must have a prior kidney biopsy with either diagnosis. Another kidney biopsy will not be required as part of the study. Candidates must have failed or be intolerant of prior therapy for their kidney disease. The failed or intolerant therapy must include corticosteroids and at least one other drug. Candidates can be adults and children over the age of 6. Abatacept will be administered by venous infusion every 4 weeks.
Study Details
Timeline
Interventions
Abatacept IV administered on Day 1, 15, 29 and then every 28 days
Normal Saline administer on Day 1, 15, 29 and then every 28 days
Dextrose 5% in Water (D5W) administered on Day 1, 15, 29 and then every 28 days