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

Anthera Pharmaceuticals

Status and phase: Withdrawn; Phase 3

Conditions: IgA Nephropathy

Treatments: Drug: Placebo; Drug: Blisibimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT02052219

AN-IGN3331

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Blisibimod

Experimental group

Treatment:

Drug: Blisibimod

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo