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Trial record 1 of 1 for:    BRIGHT Anthera
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BRIGHT-SC: Blisibimod Response in IgA Nephropathy Following At-Home Treatment by Subcutaneous Administration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02062684
Recruitment Status : Completed
First Posted : February 14, 2014
Last Update Posted : September 18, 2017
Information provided by (Responsible Party):
Anthera Pharmaceuticals

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of subcutaneous blisibimod administration in addition to standard therapy in patients with biopsy proven IgA Nephropathy with persistent proteinuria of between 1-6 g/day.

Condition or disease Intervention/treatment Phase
IgA Nephropathy Drug: Blisibimod Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy
Actual Study Start Date : June 2013
Actual Primary Completion Date : March 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Blisibimod
Blisibimod administered subcutaneously
Drug: Blisibimod
Placebo Comparator: Placebo
Placebo administered subcutaneously
Drug: Placebo

Primary Outcome Measures :
  1. Proportion of subjects achieving reduction in proteinuria from baseline [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in serum immunoglobulins IgA, IgG and IgM [ Time Frame: 24 weeks ]
  2. Percent reduction from baseline in plasma cells and B-cell subsets [ Time Frame: 24 weeks ]
  3. Percent change from baseline in complement C3 and C4 [ Time Frame: 24 weeks ]
  4. Proportion of subjects progressing to End Stage Renal Disease [ Time Frame: Approximately 104 weeks ]
  5. Proportion of subjects achieving reduction in proteinuria from baseline [ Time Frame: Approximately 104 weeks ]
  6. Numbers of subjects requiring the addition of corticosteroid or other therapy [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 - 65 years of age, inclusive
  • Biopsy-proven IgA nephropathy
  • Receiving stable, clinically-optimized ACEI and/or ARB
  • Proteinuria ≥ 1g/24hr but ≤ 6g/24hr at 2 consecutive time points

Exclusion Criteria:

  • Clinical or histologic evidence of non-IgA-related glomerulonephritis
  • IgA nephropathy with greater than 50% glomerulosclerosis or cortical scarring
  • Meets eGFR criteria
  • History of treatment with oral or parenteral corticosteroids within 3 months or immunosuppressants within 6 months
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02062684

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Sponsors and Collaborators
Anthera Pharmaceuticals
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Anthera Pharmaceuticals Identifier: NCT02062684    
Other Study ID Numbers: AN-IGN3321
First Posted: February 14, 2014    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017
Keywords provided by Anthera Pharmaceuticals:
IgA Nephropathy
Kidney Disease
Persistent proteinuria
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Autoimmune Diseases
Immune System Diseases