BRIGHT-SC: Blisibimod Response in IgA Nephropathy Following At-Home Treatment by Subcutaneous Administration

Anthera Pharmaceuticals

Status and phase

Completed

Phase 3

Phase 2

Conditions

IgA Nephropathy

Treatments

Drug: Placebo

Drug: Blisibimod

Study type

Interventional

Funder types

Industry

Identifiers

NCT02062684

AN-IGN3321

Details and patient eligibility

About

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.

Enrollment

57 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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