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Recruiting

Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Adults and Children 6 Years and Older With Excessive Loss of Protein in the Urine Due to Either Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD) - IM101-566

Updated: 09 November, 2018   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participants Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 2

    Phase

  • Gender(s)

  • 6+

    Age Range

  • 28

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Abatacept
Drug: Abatacept
Other: Placebo
Other: D5W Other: Normal Saline

Key Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Male and female subjects ages ≥ 6 years - Subjects resistant to corticosteroids, calcineurin inhibitors (cyclosporine and tacrolimus), sirolimus, mycophenolate mofetil (MMF), mycophenolic acid (MPA), or cyclophosphamide or intolerant to at least 2 of these - UPCR ≥ 3 at screening - FSGS or MCD confirmed by renal biopsy - eGFR ≥ 45 for children and adults - Concomitant use of angiotensin-converting-enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) at stable doses for at least 2 weeks or have intolerance documented in the source documents maintained at the site Exclusion Criteria: - Kidney diseases other than FSGS or MCD - Collapsing FSGS - Systemic lupus erythematosus - Diabetes mellitus, both type 1 and type 2 - Clinically significant congestive heart failure - Post renal transplantation, including relapsing post-transplant FSGS - Body mass index (BMI): > 40 in subjects ≥ 18 years of age and ≥ 99% percentile for subjects < 18 years of age Other protocol defined inclusion/exclusion criteria may apply

Have questions? Call 855-907-3286 or Email Us

Have questions?
Call 855-907-3286 or Email Us