BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2014
Longer than P75 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2014
CompletedFirst Posted
Study publicly available on registry
February 3, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedJuly 30, 2015
July 1, 2015
2 years
January 29, 2014
July 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The proportion of subjects to achieve the proteinuria threshold
Week 24
The proportion of subjects who progress to end-stage renal disease
approximately 5 years
Secondary Outcomes (5)
Change from baseline in serum immunoglobulins IgA, IgG and IgM, plasma cells and B cell subsets
Week 24
Number of Participants with Adverse Events
Week 24
Change from baseline in serum creatinine
Week 24
Change from baseline in eGFR
Week 24
The proportion of subjects requiring the addition of corticosteroid or other therapy
Week 24
Study Arms (2)
Blisibimod
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- years of age or older.
- Biopsy-proven IgA nephropathy
- Proteinuria ≥ 2g/24hr or equivalent
- Receiving physician-directed optimized standard of care that includes ACEI and/or ARB.
- Estimated glomerular filtration rate (eGFR) \>40mL/min/1.73m2
You may not qualify if:
- Clinical or histologic evidence of non-IgA-related glomerulonephritis
- IgA nephropathy with greater than 50% glomerulosclerosis or cortical scarring
- Meets eGFR criteria
- Malignancy within past 5 years
- Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C
- Liver disease
- Neutropenia
- Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections
- History of active tuberculosis or a history of tuberculosis infection
- Pregnant or nursing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2014
First Posted
February 3, 2014
Study Start
October 1, 2014
Primary Completion
October 1, 2016
Study Completion
October 1, 2021
Last Updated
July 30, 2015
Record last verified: 2015-07