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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 August 2015
• Main ID: NCT02052219
• Date of registration: 29/01/2014
• Prospective Registration: Yes
• Primary sponsor: Anthera Pharmaceuticals
• Public title: BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy
• Date of first enrolment: October 2014
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02052219
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

IgA Nephropathy

Intervention(s)

Drug: Placebo

Drug: Blisibimod

Primary Outcome(s)

The proportion of subjects who progress to end-stage renal disease [Time Frame: approximately 5 years]

The proportion of subjects to achieve the proteinuria threshold [Time Frame: Week 24]

Secondary Outcome(s)

Change from baseline in eGFR [Time Frame: Week 24]

Number of Participants with Adverse Events [Time Frame: Week 24]

The proportion of subjects requiring the addition of corticosteroid or other therapy [Time Frame: Week 24]

Change from baseline in serum creatinine [Time Frame: Week 24]

Change from baseline in serum immunoglobulins IgA, IgG and IgM, plasma cells and B cell subsets [Time Frame: Week 24]

Secondary ID(s)

AN-IGN3331

Source(s) of Monetary Support

Please refer to primary and secondary sponsors