Clinical Trials List
2013-07-01 - 2017-05-26
Phase II/III
Terminated6
ICD-10N05.0
Unspecified nephritic syndrome with minor glomerular abnormality
ICD-10N05.1
Unspecified nephritic syndrome with focal and segmental glomerular lesions
ICD-10N05.6
Unspecified nephritic syndrome with dense deposit disease
ICD-10N05.7
Unspecified nephritic syndrome with diffuse crescentic glomerulonephritis
ICD-10N05.8
Unspecified nephritic syndrome with other morphologic changes
ICD-10N06.0
Isolated proteinuria with minor glomerular abnormality
ICD-10N06.1
Isolated proteinuria with focal and segmental glomerular lesions
ICD-10N06.6
Isolated proteinuria with dense deposit disease
ICD-10N06.7
Isolated proteinuria with diffuse crescentic glomerulonephritis
ICD-10N06.8
Isolated proteinuria with other morphologic lesion
ICD-10N07.0
Hereditary nephropathy, not elsewhere classified with minor glomerular abnormality
ICD-10N07.1
Hereditary nephropathy, not elsewhere classified with focal and segmental glomerular lesions
ICD-10N07.6
Hereditary nephropathy, not elsewhere classified with dense deposit disease
ICD-10N07.7
Hereditary nephropathy, not elsewhere classified with diffuse crescentic glomerulonephritis
ICD-10N07.8
Hereditary nephropathy, not elsewhere classified with other morphologic lesions
ICD-10N14.0
Analgesic nephropathy
ICD-10N14.1
Nephropathy induced by other drugs, medicaments and biological substances
ICD-10N14.2
Nephropathy induced by unspecified drug, medicament or biological substance
ICD-10N14.3
Nephropathy induced by heavy metals
ICD-10N14.4
Toxic nephropathy, not elsewhere classified
ICD-10N15.0
Balkan nephropathy
ICD-10N15.8
Other specified renal tubulo-interstitial diseases
ICD-9583.89
Nephritis and nephropathy, not specified as acute or chronic, with other specified pathological lesion in kidney
A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy
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Trial Applicant
CHILTERN RESEARCH INTERNATIONAL (SINGAPORE) PTE. LTD.
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Sponsor
Anthera Pharmaceuticals Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
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 ]
Inclution 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
The Estimated Number of Participants
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Taiwan
25 participants
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Global
58 participants
