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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Anthera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02062684
First received: February 12, 2014
Last updated: May 19, 2017
Last verified: May 2017
  Purpose
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 Intervention Phase
IgA Nephropathy Drug: Blisibimod Drug: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Anthera Pharmaceuticals:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 57
Actual Study Start Date: June 2013
Estimated Study Completion Date: May 31, 2017
Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Blisibimod
Blisibimod administered subcutaneously
Drug: Blisibimod
Placebo Comparator: Placebo
Placebo administered subcutaneously
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02062684

Locations
Czechia
Investigator Site 852
Olomouc, Czechia
Investigator 851
Prague, Czechia
Germany
Investigator Site 905
Dusseldorf, Germany, 40210
Hong Kong
Investigator Site 101
Hong Kong, Hong Kong
Korea, Republic of
Investigator Site 305
Busan, Korea, Republic of, 612-896
Investigator Site 306
Busan, Korea, Republic of, 614-735
Investigator Site 303
Daejeon, Korea, Republic of, 301-721
Investigator Site 301
Seoul, Korea, Republic of, 110-744
Investigator Site 302
Seoul, Korea, Republic of, 137-701
Malaysia
Investigator Site 603
Kajang, Malaysia, 43000
Philippines
Investigator Site 402
Quezon City, Philippines, 1101
Investigator Site 401
Quezon City, Philippines
Singapore
Investigator Site 202
Singapore, Singapore, 169608
Investigator Site 201
Singapore, Singapore, 308433
Taiwan
Investigator Site 704
Changhua, Taiwan, 500
Investigator Site 705
Tainan, Taiwan, 70428
Thailand
Investigator Site 504
Bangkok, Thailand, 10330
Investigator Site 505
Bangkok, Thailand, 10400
Investigator Site 503
Bangkok, Thailand, 10700
Investigator Site 501
Chang Mai, Thailand, 50200
United Kingdom
Investigator Site 806
Bradford, United Kingdom
Investigator Site 801
Leicester, United Kingdom
Investigator Site 803
London, United Kingdom
Sponsors and Collaborators
Anthera Pharmaceuticals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anthera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02062684     History of Changes
Other Study ID Numbers: AN-IGN3321
Study First Received: February 12, 2014
Last Updated: May 19, 2017

Keywords provided by Anthera Pharmaceuticals:
IgAN
IgA Nephropathy
A-623
Blisibimod
Kidney Disease
Persistent proteinuria

Additional relevant MeSH terms:
Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 22, 2017