BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy
Primary Purpose
IgA Nephropathy
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Blisibimod
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for IgA Nephropathy focused on measuring Blisibimod, IgA nephropathy, BAFF, BLyS
Eligibility Criteria
Inclusion Criteria:
- 18 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Blisibimod
Placebo
Arm Description
Outcomes
Primary Outcome Measures
The proportion of subjects to achieve the proteinuria threshold
The proportion of subjects who progress to end-stage renal disease
Secondary Outcome Measures
Change from baseline in serum immunoglobulins IgA, IgG and IgM, plasma cells and B cell subsets
Number of Participants with Adverse Events
Change from baseline in serum creatinine
Change from baseline in eGFR
The proportion of subjects requiring the addition of corticosteroid or other therapy
Full Information
NCT ID
NCT02052219
First Posted
January 29, 2014
Last Updated
July 28, 2015
Sponsor
Anthera Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02052219
Brief Title
BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Withdrawn
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
October 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anthera Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Nephropathy
Keywords
Blisibimod, IgA nephropathy, BAFF, BLyS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blisibimod
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Blisibimod
Intervention Description
Blisibimod administered subcutaneously
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered subcutaneously
Primary Outcome Measure Information:
Title
The proportion of subjects to achieve the proteinuria threshold
Time Frame
Week 24
Title
The proportion of subjects who progress to end-stage renal disease
Time Frame
approximately 5 years
Secondary Outcome Measure Information:
Title
Change from baseline in serum immunoglobulins IgA, IgG and IgM, plasma cells and B cell subsets
Time Frame
Week 24
Title
Number of Participants with Adverse Events
Time Frame
Week 24
Title
Change from baseline in serum creatinine
Time Frame
Week 24
Title
Change from baseline in eGFR
Time Frame
Week 24
Title
The proportion of subjects requiring the addition of corticosteroid or other therapy
Time Frame
Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 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
Exclusion Criteria:
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
12. IPD Sharing Statement
Learn more about this trial
BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy
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