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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
57
Investigator Site 852
Olomouc, Czechia
Investigator 851
Prague, Czechia
Proportion of subjects achieving reduction in proteinuria from baseline
Time frame: 24 weeks
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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Investigator Site 905
Düsseldorf, Germany
Investigator Site 101
Hong Kong, Hong Kong
Investigator Site 603
Kajang, Malaysia
Investigator Site 402
Quezon City, Philippines
Investigator Site 401
Quezon City, Philippines
Investigator Site 202
Singapore, Singapore
Investigator Site 201
Singapore, Singapore
Investigator Site 305
Busan, South Korea
...and 13 more locations