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

Primary Purpose

IgA Nephropathy

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Blisibimod

Placebo

About this trial

This is an interventional treatment trial for IgA Nephropathy focused on measuring Blisibimod, IgA nephropathy, BAFF, BLyS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Blisibimod

Placebo

Arm Description

Outcomes

Primary Outcome Measures

The proportion of subjects to achieve the proteinuria threshold

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

Secondary Outcome Measures

Change from baseline in serum immunoglobulins IgA, IgG and IgM, plasma cells and B cell subsets

Number of Participants with Adverse Events

Change from baseline in serum creatinine

Change from baseline in eGFR

The proportion of subjects requiring the addition of corticosteroid or other therapy

Full Information

NCT ID

NCT02052219

First Posted

January 29, 2014

Last Updated

July 28, 2015

Sponsor

Anthera Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02052219

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Withdrawn

Study Start Date

October 2014 (undefined)

Primary Completion Date

October 2016 (Anticipated)

Study Completion Date

October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Anthera Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

IgA Nephropathy

Keywords

Blisibimod, IgA nephropathy, BAFF, BLyS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Blisibimod

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Blisibimod

Intervention Description

Blisibimod administered subcutaneously

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo administered subcutaneously

Primary Outcome Measure Information:

Title

The proportion of subjects to achieve the proteinuria threshold

Time Frame

Week 24

Title

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

Time Frame

approximately 5 years

Secondary Outcome Measure Information:

Title

Change from baseline in serum immunoglobulins IgA, IgG and IgM, plasma cells and B cell subsets

Time Frame

Week 24

Title

Number of Participants with Adverse Events

Time Frame

Week 24

Title

Change from baseline in serum creatinine

Time Frame

Week 24

Title

Change from baseline in eGFR

Time Frame

Week 24

Title

The proportion of subjects requiring the addition of corticosteroid or other therapy

Time Frame

Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

Learn more about this trial

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

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