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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Withdrawn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
Sponsored by
Anthera Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

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

    First Posted
    January 29, 2014
    Last Updated
    July 28, 2015
    Sponsor
    Anthera Pharmaceuticals
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    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
    No
    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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