BRIGHT-SC: Blisibimod Response in IgA Nephropathy Following At-Home Treatment by Subcutaneous Administration

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

Tracking Information

• First Submitted Date: February 12, 2014
• First Posted Date: February 14, 2014
• Last Update Posted Date: September 18, 2017
• Actual Study Start Date: June 2013
• Actual Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 12, 2014): Proportion of subjects achieving reduction in proteinuria from baseline [ Time Frame: 24 weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: BRIGHT-SC: Blisibimod Response in IgA Nephropathy Following At-Home Treatment by Subcutaneous Administration
• 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
• 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: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: IgA Nephropathy

Intervention

• Drug: Blisibimod
• Drug: Placebo

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 17, 2016): 57
• Original Estimated Enrollment (submitted: February 12, 2014): 200
• Actual Study Completion Date: June 30, 2017
• Actual Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: 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: NCT02062684
• Other Study ID Numbers: AN-IGN3321
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Anthera Pharmaceuticals
• Original Responsible Party: Same as current
• Current Study Sponsor: Anthera Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Anthera Pharmaceuticals
• Verification Date: September 2017