Tests isuzinaxib in adults with diabetic kidney disease
Tests isuzinaxib against a placebo in adults with diabetic kidney disease.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety Study of Isuzinaxib in Subjects With DKD
Key facts
- Where
- Ansan-si, Busan, Cheonan, Daegu, Goyang-si, Guri-si, Gwangmyeong, Incheon, Jeonju, Seongnam-si, Seoul, Uijeongbu-si, Wŏnju, and Yangsan, South KoreaSee the 20 sites
- Phase
- Phase 2
Where in South Korea
- Korea University Ansan HospitalAnsan-si, South KoreaTaking people
- Inje University Busan Paik HospitalBusan, South KoreaNot yet recruiting
- Pusan National University HospitalBusan, South KoreaTaking people
- Soonchunhyang University Hospital CheonanCheonan, South KoreaTaking people
- Keimyung University Daegu Dongsan HospitalDaegu, South KoreaTaking people
- Inje University Ilsan Paik HospitalGoyang-si, South KoreaTaking people
- Hanyang University Guri HospitalGuri-si, South KoreaTaking people
- Chung-Ang University Gwangmyeong HospitalGwangmyeong, South KoreaTaking people
- The Catholic University of Korea, Incheon St. Mary's HospitalIncheon, South KoreaTaking people
- jeonbuk National University HospitalJeonju, South KoreaNot yet recruiting
- CHA Bundang Medical CenterSeongnam-si, South KoreaTaking people
- Boramae Medical CenterSeoul, South KoreaTaking people
- Korea University Guro HospitalSeoul, South KoreaTaking people
- Kyung Hee University Hospital at GangdonSeoul, South KoreaTaking people
- Seoul National University HospitalSeoul, South KoreaTaking people
- Severance hospitalSeoul, South KoreaTaking people
- The Catholic University of Korea, Seoul ST. Mary's HospitalSeoul, South KoreaTaking people
- The Catholic University of Korea Uijeongbu St. Mary's HospitalUijeongbu-si, South KoreaTaking people
- Wonju Severance Christian HospitalWŏnju, South KoreaNot yet recruiting
- Pusan National University Yangsan HospitalYangsan, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Aptabio Therapeutics, Inc.
- Trial code
- NCT06962098
- Record updated
- 18 July 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: History of drug or alcohol abuse within 1 year prior to screening; Administration of any investigational product; Major surgery within 28 days or not fully recovered surgery prior to randomization or major surgery planned during the next 6 months; History of type 1 diabetes mellitus or gestational diabetes; Subject's renal impairment and/or albuminuria is considered to be of origin other than DKD; History of renal transplant and/or plan to undergo a renal transplant during the study; History of acute kidney injury or renal dialysis; Subject with known or suspected hypersensitivity to any components of the APX-115 formulation; History of any cardiovascular event or cardiovascular procedure planned during the clinical study; Current or history of New York Heart Association class III or IV heart failure; Known significant liver disease; Subject with active urinary tract infection or has not fully recovered before randomization; History of malignancy within 5 years prior to screening; Positive hepatitis B surface antigen; Clinically significant abnormal laboratory findings at screening; Subject with uncontrolled blood pressure; Subject taking immunosuppressant; Clinically significant electrocardiogram (ECG) abnormalities; Female subject who is pregnant or breastfeeding; Other medical history which in the opinion of the Investigator would make the subject unsuitable for participation in the study; Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study or unable to cooperate because of a language problem or poor mental status.