BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy
NCT ID: NCT02052219
Last Updated: 2015-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2014-10-31
2021-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Blisibimod
Blisibimod
Blisibimod administered subcutaneously
Placebo
Placebo
Placebo administered subcutaneously
Interventions
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Blisibimod
Blisibimod administered subcutaneously
Placebo
Placebo administered subcutaneously
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Anthera Pharmaceuticals
INDUSTRY
Responsible Party
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Other Identifiers
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AN-IGN3331
Identifier Type: -
Identifier Source: org_study_id
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