Clinical trial of tamibarotene in patients with Autosomal Dominant Polycystic Kidney Disease
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
70
Subjects are administrated to tamibarotene 4 mg in daily for 52 weeks.
Subjects are administrated to placebo in daily for 52 weeks.
Kurume University Hospital
Kurume, Fukuoka, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Shonan Kamakura General Hospital
Kamakura, Kanagawa, Japan
Toranomon Hospital Kajigaya
Kawasaki, Kanagawa, Japan
Changes in TKV from baseline
TKV
Time frame: 52 Week after administration of Investigational Product
Changes in TLV from baseline
TLV
Time frame: 52 Week after administration of Investigational Product
Changes in eGFR from baseline
eGFR
Time frame: 52 Week after administration of Investigational Product
Incidence of adverse events
Safety
Time frame: 1 year
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Kyoto University Hospital
Kyoto, Kyoto, Japan
Juntendo University School of Medicine Juntendo Hospital
Bunkyo-ku, Tokyo, Japan
Toranomon Hospital
Minato-ku, Tokyo, Japan
Tokyo Women's Medical University Hospital
Shinjukuku, Tokyo, Japan