Trial record 1 of 1 for:
BRIGHT Anthera
BRIGHT-SC: Blisibimod Response in IgA Nephropathy Following At-Home Treatment by Subcutaneous Administration
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| ClinicalTrials.gov Identifier: NCT02062684 |
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Recruitment Status :
Completed
First Posted : February 14, 2014
Last Update Posted : September 18, 2017
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Sponsor:
Anthera Pharmaceuticals
Information provided by (Responsible Party):
Anthera Pharmaceuticals
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| IgA Nephropathy | Drug: Blisibimod Drug: Placebo | Phase 2 Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 57 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 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy |
| Actual Study Start Date : | June 2013 |
| Actual Primary Completion Date : | March 2017 |
| Actual Study Completion Date : | June 30, 2017 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Kidney Diseases
| Arm | Intervention/treatment |
|---|---|
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Experimental: Blisibimod
Blisibimod administered subcutaneously
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Drug: Blisibimod |
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Placebo Comparator: Placebo
Placebo administered subcutaneously
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Drug: Placebo |
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 ]
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02062684
Locations
Show 23 study locations
Sponsors and Collaborators
Anthera Pharmaceuticals
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Anthera Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT02062684 |
| Other Study ID Numbers: |
AN-IGN3321 |
| First Posted: | February 14, 2014 Key Record Dates |
| Last Update Posted: | September 18, 2017 |
| Last Verified: | September 2017 |
Keywords provided by Anthera Pharmaceuticals:
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IgAN IgA Nephropathy A-623 |
Blisibimod Kidney Disease Persistent proteinuria |
Additional relevant MeSH terms:
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Kidney Diseases Glomerulonephritis, IGA Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases |
Male Urogenital Diseases Glomerulonephritis Nephritis Autoimmune Diseases Immune System Diseases |