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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: IgA Nephropathy
• Intervention / Treatment: Drug: Placebo; Drug: Blisibimod

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo administered subcutaneously
Experimental: Blisibimod	Drug: Blisibimod; Blisibimod administered subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of subjects to achieve the proteinuria threshold	Week 24
The proportion of subjects who progress to end-stage renal disease	approximately 5 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Anthera Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: January 29, 2014
• First Submitted That Met QC Criteria: January 30, 2014
• First Posted (Estimate): February 3, 2014

Study Record Updates

• Last Update Posted (Estimate): July 30, 2015
• Last Update Submitted That Met QC Criteria: July 28, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: IgA nephropathy; BLyS; Blisibimod; BAFF
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Urologic Diseases; Nephritis; Glomerulonephritis; Kidney Diseases; Glomerulonephritis, IGA
• Other Study ID Numbers: AN-IGN3331