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

NCT ID: NCT02052219

Last Updated: 2015-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2021-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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IgA Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Blisibimod

Group Type EXPERIMENTAL

Blisibimod

Intervention Type DRUG

Blisibimod administered subcutaneously

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo administered subcutaneously

Interventions

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Blisibimod

Blisibimod administered subcutaneously

Intervention Type DRUG

Placebo

Placebo administered subcutaneously

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anthera Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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AN-IGN3331

Identifier Type: -

Identifier Source: org_study_id

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