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

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.
 
ClinicalTrials.gov Identifier: NCT02052219
Recruitment Status : Withdrawn
First Posted : February 3, 2014
Last Update Posted : July 30, 2015
Sponsor:
Information provided by (Responsible Party):
Anthera Pharmaceuticals

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 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 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy
Study Start Date : October 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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

Placebo Comparator: Placebo Drug: Placebo
Placebo administered subcutaneously




Primary Outcome Measures :
  1. The proportion of subjects to achieve the proteinuria threshold [ Time Frame: Week 24 ]
  2. The proportion of subjects who progress to end-stage renal disease [ Time Frame: approximately 5 years ]

Secondary Outcome Measures :
  1. Change from baseline in serum immunoglobulins IgA, IgG and IgM, plasma cells and B cell subsets [ Time Frame: Week 24 ]
  2. Number of Participants with Adverse Events [ Time Frame: Week 24 ]
  3. Change from baseline in serum creatinine [ Time Frame: Week 24 ]
  4. Change from baseline in eGFR [ Time Frame: Week 24 ]
  5. The proportion of subjects requiring the addition of corticosteroid or other therapy [ Time Frame: Week 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: Anthera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02052219    
Other Study ID Numbers: AN-IGN3331
First Posted: February 3, 2014    Key Record Dates
Last Update Posted: July 30, 2015
Last Verified: July 2015
Keywords provided by Anthera Pharmaceuticals:
Blisibimod
IgA nephropathy
BAFF
BLyS
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases