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

Primary Purpose

IgA Nephropathy

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Blisibimod
Placebo
Sponsored by
Anthera Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IgA Nephropathy focused on measuring IgAN, IgA Nephropathy, A-623, Blisibimod, Kidney Disease, Persistent proteinuria

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigator Site 852
  • Investigator 851
  • Investigator Site 905
  • Investigator Site 101
  • Investigator Site 305
  • Investigator Site 306
  • Investigator Site 303
  • Investigator Site 301
  • Investigator Site 302
  • Investigator Site 603
  • Investigator Site 402
  • Investigator Site 401
  • Investigator Site 202
  • Investigator Site 201
  • Investigator Site 704
  • Investigator Site 705
  • Investigator Site 504
  • Investigator Site 505
  • Investigator Site 503
  • Investigator Site 501
  • Investigator Site 806
  • Investigator Site 801
  • Investigator Site 803

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Blisibimod

Placebo

Arm Description

Blisibimod administered subcutaneously

Placebo administered subcutaneously

Outcomes

Primary Outcome Measures

Proportion of subjects achieving reduction in proteinuria from baseline

Secondary Outcome Measures

Change from baseline in serum immunoglobulins IgA, IgG and IgM
Percent reduction from baseline in plasma cells and B-cell subsets
Percent change from baseline in complement C3 and C4
Proportion of subjects progressing to End Stage Renal Disease
Proportion of subjects achieving reduction in proteinuria from baseline
Numbers of subjects requiring the addition of corticosteroid or other therapy

Full Information

First Posted
February 12, 2014
Last Updated
September 14, 2017
Sponsor
Anthera Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02062684
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anthera Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Nephropathy
Keywords
IgAN, IgA Nephropathy, A-623, Blisibimod, Kidney Disease, Persistent proteinuria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blisibimod
Arm Type
Experimental
Arm Description
Blisibimod administered subcutaneously
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered subcutaneously
Intervention Type
Drug
Intervention Name(s)
Blisibimod
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Proportion of subjects achieving reduction in proteinuria from baseline
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in serum immunoglobulins IgA, IgG and IgM
Time Frame
24 weeks
Title
Percent reduction from baseline in plasma cells and B-cell subsets
Time Frame
24 weeks
Title
Percent change from baseline in complement C3 and C4
Time Frame
24 weeks
Title
Proportion of subjects progressing to End Stage Renal Disease
Time Frame
Approximately 104 weeks
Title
Proportion of subjects achieving reduction in proteinuria from baseline
Time Frame
Approximately 104 weeks
Title
Numbers of subjects requiring the addition of corticosteroid or other therapy
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Investigator Site 852
City
Olomouc
Country
Czechia
Facility Name
Investigator 851
City
Prague
Country
Czechia
Facility Name
Investigator Site 905
City
Dusseldorf
ZIP/Postal Code
40210
Country
Germany
Facility Name
Investigator Site 101
City
Hong Kong
Country
Hong Kong
Facility Name
Investigator Site 305
City
Busan
ZIP/Postal Code
612-896
Country
Korea, Republic of
Facility Name
Investigator Site 306
City
Busan
ZIP/Postal Code
614-735
Country
Korea, Republic of
Facility Name
Investigator Site 303
City
Daejeon
ZIP/Postal Code
301-721
Country
Korea, Republic of
Facility Name
Investigator Site 301
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Investigator Site 302
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Investigator Site 603
City
Kajang
ZIP/Postal Code
43000
Country
Malaysia
Facility Name
Investigator Site 402
City
Quezon City
ZIP/Postal Code
1101
Country
Philippines
Facility Name
Investigator Site 401
City
Quezon City
Country
Philippines
Facility Name
Investigator Site 202
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Investigator Site 201
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Investigator Site 704
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Investigator Site 705
City
Tainan
ZIP/Postal Code
70428
Country
Taiwan
Facility Name
Investigator Site 504
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Investigator Site 505
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Investigator Site 503
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Investigator Site 501
City
Chang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Investigator Site 806
City
Bradford
Country
United Kingdom
Facility Name
Investigator Site 801
City
Leicester
Country
United Kingdom
Facility Name
Investigator Site 803
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26032537
Citation
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.
Results Reference
derived

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

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