Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT02062684
Recruitment Status : Completed
First Posted : February 14, 2014
Last Update Posted : September 18, 2017
Sponsor:
Information provided by (Responsible Party):
Anthera Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE February 12, 2014
First Posted Date  ICMJE February 14, 2014
Last Update Posted Date September 18, 2017
Actual Study Start Date  ICMJE June 2013
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2014)
Proportion of subjects achieving reduction in proteinuria from baseline [ Time Frame: 24 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02062684 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2014)
  • Change from baseline in serum immunoglobulins IgA, IgG and IgM [ Time Frame: 24 weeks ]
  • Percent reduction from baseline in plasma cells and B-cell subsets [ Time Frame: 24 weeks ]
  • Percent change from baseline in complement C3 and C4 [ Time Frame: 24 weeks ]
  • Proportion of subjects progressing to End Stage Renal Disease [ Time Frame: Approximately 104 weeks ]
  • Proportion of subjects achieving reduction in proteinuria from baseline [ Time Frame: Approximately 104 weeks ]
  • Numbers of subjects requiring the addition of corticosteroid or other therapy [ Time Frame: 24 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BRIGHT-SC: Blisibimod Response in IgA Nephropathy Following At-Home Treatment by Subcutaneous Administration
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE IgA Nephropathy
Intervention  ICMJE
  • Drug: Blisibimod
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Blisibimod
    Blisibimod administered subcutaneously
    Intervention: Drug: Blisibimod
  • Placebo Comparator: Placebo
    Placebo administered subcutaneously
    Intervention: Drug: Placebo
Publications * Yeo SC, Liew A, Barratt J. Emerging therapies in immunoglobulin A nephropathy. Nephrology (Carlton). 2015 Nov;20(11):788-800. doi: 10.1111/nep.12527.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 17, 2016)
57
Original Estimated Enrollment  ICMJE
 (submitted: February 12, 2014)
200
Actual Study Completion Date  ICMJE June 30, 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   Germany,   Hong Kong,   Korea, Republic of,   Malaysia,   Philippines,   Singapore,   Taiwan,   Thailand,   United Kingdom
Removed Location Countries Canada,   Czech Republic,   Italy,   Russian Federation,   Spain
 
Administrative Information
NCT Number  ICMJE NCT02062684
Other Study ID Numbers  ICMJE AN-IGN3321
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anthera Pharmaceuticals
Study Sponsor  ICMJE Anthera Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Anthera Pharmaceuticals
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP