A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy

Anthera Pharmaceuticals0 sitesOctober 2014

ConditionsIgA Nephropathy

InterventionsBlisibimod Placebo

DrugsBlisibimod Placebo

Overview

Phase: Phase 3
Intervention: Blisibimod
Conditions: IgA Nephropathy
Sponsor: Anthera Pharmaceuticals
Primary Endpoint: The proportion of subjects to achieve the proteinuria threshold
Status: Withdrawn
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 2014

End Date

October 2021

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Anthera Pharmaceuticals

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Blisibimod

Intervention: Blisibimod

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

The proportion of subjects to achieve the proteinuria threshold

Time Frame: Week 24

The proportion of subjects who progress to end-stage renal disease

Time Frame: approximately 5 years

Secondary Outcomes

Change from baseline in serum creatinine(Week 24)
Number of Participants with Adverse Events(Week 24)
The proportion of subjects requiring the addition of corticosteroid or other therapy(Week 24)
Change from baseline in serum immunoglobulins IgA, IgG and IgM, plasma cells and B cell subsets(Week 24)
Change from baseline in eGFR(Week 24)