This study is a multicenter, double-blinded, randomized, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, PK, and efficacy of Isuzinaxib compared with placebo in subjects with DKD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
186
Oral dosing regimen once daily
Oral dosing regimen once daily
Korea University Ansan Hospital
Ansan-si, South Korea
RECRUITINGEfficacy endpoint: Urine Albumin-Creatinine Ratio
Change in Urine Albumin-Creatinine Ratio from baseline through Week 24 in the Isuzinaxib treatment groups versus the placebo group
Time frame: Over 24 Weeks
Efficacy endpoint: eGFR
Change from baseline in the eGFR
Time frame: Over 24 Weeks
Efficacy endpoint: Urine Albumin-Creatinine Ratio
Change in Urine Albumin-Creatinine Ratio from baseline through Week 20 in the Isuzinaxib treatment groups versus the placebo group
Time frame: Over 20 Weeks
Efficacy endpoint: Urine Albumin-Creatinine Ratio decrease
Subjects with a percentage decrease in Urine Albumin-Creatinine Ratio
Time frame: Over 24 Weeks
Efficacy endpoint: Incidence of Composite Renal Outcome
Number of subjects with end-stage kidney disease, kidney-related death, or renal replacement therapy
Time frame: Over 24 Weeks
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of treatment-emergent adverse events
Time frame: Over 24 Weeks
PK Endpoint: Pharmacokinetics
Assessment of plasma concentrations of Isuzinaxib
Time frame: Over 24 Weeks
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Inje university Busan Paik Hospital
Busan, South Korea
NOT_YET_RECRUITINGPusan National University Hospital
Busan, South Korea
RECRUITINGSoonChunHyang University Hospital Cheonan
Cheonan, South Korea
RECRUITINGKeimyung University Daegu Dongsan Hospital
Daegu, South Korea
RECRUITINGInje university Ilsan Paik Hospital
Goyang-si, South Korea
RECRUITINGHanyang University Guri Hospital
Guri-si, South Korea
RECRUITINGChung-Ang University Gwangmyeong Hospital
Gwangmyeong, South Korea
RECRUITINGThe Catholic University of Korea Incheon St. Mary's Hospital
Incheon, South Korea
RECRUITINGJeonbuk National University Hospital
Jeonju, South Korea
NOT_YET_RECRUITING...and 10 more locations