Clinical Trial: BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy

Brief Summary: The purpose of this study is to compare the effect of blisibimod plus standard of care versus placebo plus standard of care alone on the proportion of subjects achieving improvement in renal disease parameters.

Detailed Summary:
Sponsor: Anthera Pharmaceuticals

Current Primary Outcome:

  • The proportion of subjects to achieve the proteinuria threshold [ Time Frame: Week 24 ]
  • The proportion of subjects who progress to end-stage renal disease [ Time Frame: approximately 5 years ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in serum immunoglobulins IgA, IgG and IgM, plasma cells and B cell subsets [ Time Frame: Week 24 ]
  • Number of Participants with Adverse Events [ Time Frame: Week 24 ]
  • Change from baseline in serum creatinine [ Time Frame: Week 24 ]
  • Change from baseline in eGFR [ Time Frame: Week 24 ]
  • The proportion of subjects requiring the addition of corticosteroid or other therapy [ Time Frame: Week 24 ]


Original Secondary Outcome: Same as current

Information By: Anthera Pharmaceuticals

Dates:
Date Received: January 29, 2014
Date Started: October 2014
Date Completion: October 2021
Last Updated: July 28, 2015
Last Verified: July 2015