A Phase 2b Randomized, Double-blind, Placebo-controlled, Dose-ranging, Multicenter Study to Evaluate the Efficacy and Safety of Isuzinaxib in Subjects With Diabetic Kidney Disease
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• Male/female subject aged ≥19 years inclusive at the time of informed consent.
• Clinical diagnosis of type 2 diabetes and DKD.
• 18.5 kg/m² \< body mass index \< 35 kg/m².
• Stable UACR values prior to screening visit.
• UACR between 200 and 3000 mg/g.
• Hemoglobin A1c ≤10% at Screening Visit.
• Subject who has been taking unchanged dosage of angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blockers (ARB) medication.
• Subject who has been on stable anti-hyperglycemic prior to screening.
• Females of childbearing potential/sexually active males with a partner of childbearing potential: commitment to consistently and correctly use an acceptable method of birth control.
⁃ Willing to be under dietary management for diabetes.
⁃ Willing to comply with all study procedures and availability for the duration of the study.
⁃ Capable of understanding the content of and able voluntarily to provide a signed and dated written informed consent form (ICF) prior to any study procedures.
Locations
Other Locations
Republic of Korea
Korea University Ansan Hospital
RECRUITING
Ansan-si
Inje university Busan Paik Hospital
NOT_YET_RECRUITING
Busan
Pusan National University Hospital
RECRUITING
Busan
SoonChunHyang University Hospital Cheonan
RECRUITING
Cheonan
Keimyung University Daegu Dongsan Hospital
RECRUITING
Daegu
Inje university Ilsan Paik Hospital
RECRUITING
Goyang-si
Hanyang University Guri Hospital
RECRUITING
Guri-si
Chung-Ang University Gwangmyeong Hospital
RECRUITING
Gwangmyeong
The Catholic University of Korea Incheon St. Mary's Hospital
RECRUITING
Incheon
Jeonbuk National University Hospital
NOT_YET_RECRUITING
Jeonju
CHA Bundang Medical Center
RECRUITING
Seongnam-si
Boramae Medical Center
RECRUITING
Seoul
Korea University Guro Hospital
RECRUITING
Seoul
Kyung Hee University Hospital at Gangdon
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital
RECRUITING
Seoul
The Catholic University of Korea Seoul ST.MARY'S Hospital
RECRUITING
Seoul
The Catholic University of Korea Uijeongbu St. Mary's Hospital