NCT02062684
Completed
Phase 2
A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy
Overview
- Phase
- Phase 2
- Intervention
- Blisibimod
- Conditions
- IgA Nephropathy
- Sponsor
- Anthera Pharmaceuticals
- Enrollment
- 57
- Locations
- 23
- Primary Endpoint
- Proportion of subjects achieving reduction in proteinuria from baseline
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of subcutaneous blisibimod administration in addition to standard therapy in patients with biopsy proven IgA Nephropathy with persistent proteinuria of between 1-6 g/day.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 - 65 years of age, inclusive
- •Biopsy-proven IgA nephropathy
- •Receiving stable, clinically-optimized ACEI and/or ARB
- •Proteinuria ≥ 1g/24hr but ≤ 6g/24hr at 2 consecutive time points
Exclusion Criteria
- •Clinical or histologic evidence of non-IgA-related glomerulonephritis
- •IgA nephropathy with greater than 50% glomerulosclerosis or cortical scarring
- •Meets eGFR criteria
- •History of treatment with oral or parenteral corticosteroids within 3 months or immunosuppressants within 6 months
- •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
Arms & Interventions
Blisibimod
Blisibimod administered subcutaneously
Intervention: Blisibimod
Placebo
Placebo administered subcutaneously
Intervention: Placebo
Outcomes
Primary Outcomes
Proportion of subjects achieving reduction in proteinuria from baseline
Time Frame: 24 weeks
Secondary Outcomes
- Percent change from baseline in complement C3 and C4(24 weeks)
- Proportion of subjects progressing to End Stage Renal Disease(Approximately 104 weeks)
- Proportion of subjects achieving reduction in proteinuria from baseline(Approximately 104 weeks)
- Numbers of subjects requiring the addition of corticosteroid or other therapy(24 weeks)
- Change from baseline in serum immunoglobulins IgA, IgG and IgM(24 weeks)
- Percent reduction from baseline in plasma cells and B-cell subsets(24 weeks)
Study Sites (23)
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