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

Phase 3

Withdrawn

• Conditions: IgA Nephropathy
• Interventions: Drug: Placebo; Drug: Blisibimod

• Registration Number: NCT02052219
• Lead Sponsor: Anthera Pharmaceuticals

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 Description

Not available

Study Timeline

• Study First Submitted: 2014-01-29
• Study First Submitted QC: 2014-01-30
• Study First Posted: 2014-02-03
• Study Start: 2014-10
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-28
• Last Update Posted: 2015-07-30
• Primary Completion: 2016-10
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Blisibimod	Blisibimod	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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