This trial is active, not recruiting.

Condition iga nephropathy
Treatments blisibimod, placebo
Phase phase 2/phase 3
Sponsor Anthera Pharmaceuticals
Start date July 2013
End date December 2018
Trial size 57 participants
Trial identifier NCT02062684, AN-IGN3321


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Blisibimod administered subcutaneously
(Placebo Comparator)
Placebo administered subcutaneously

Primary Outcomes

Proportion of subjects achieving reduction in proteinuria from baseline
time frame: 24 weeks

Secondary Outcomes

Change from baseline in serum immunoglobulins IgA, IgG and IgM
time frame: 24 weeks
Percent reduction from baseline in plasma cells and B-cell subsets
time frame: 24 weeks
Percent change from baseline in complement C3 and C4
time frame: 24 weeks
Proportion of subjects progressing to End Stage Renal Disease
time frame: Approximately 104 weeks
Proportion of subjects achieving reduction in proteinuria from baseline
time frame: Approximately 104 weeks
Numbers of subjects requiring the addition of corticosteroid or other therapy
time frame: 24 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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 - Pregnant or nursing

Additional Information

Official title A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Anthera Pharmaceuticals.