The purpose of this study is to evaluate the safety and the tolerability of ADR-001 in Immunoglobulin A (IgA) Nephropathy patients. In addition, the investigators will evaluate the efficacy of ADR-001 for IgA Nephropathy patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Once or twice with two week interval at a dose of 100 x 10 \^ 6 cells.
Kasugai Municipal Hospital
Kasugai, Aichi-ken, Japan
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Incidence of adverse events
Any adverse events are summarized.
Time frame: until 6 weeks after first administration
Clinical remission (proteinuria, hematuria)
Ratio and time frame to achieve remission are summarized.
Time frame: at 2, 4, 6, 12, 26, 38 and 52 weeks after first administration
Proteinuria
Change from baseline value and ratio to achieve threshold are summarized.
Time frame: at 2, 4, 6, 12, 26, 38 and 52 weeks after first administration
Hematuria
Change from baseline value and ratio to achieve threshold are summarized.
Time frame: at 2, 4, 6, 12, 26, 38 and 52 weeks after first administration
Estimated glomerular filtration rate (eGFR)
Change from baseline value are summarized.
Time frame: at 2, 4, 6, 12, 26, 38 and 52 weeks after first administration
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