Status:
RECRUITING
Efficacy and Safety Study of Isuzinaxib in Subjects With DKD
Lead Sponsor:
Aptabio Therapeutics, Inc.
Conditions:
Diabetic Kidney Disease (DKD)
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief 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 w...
Eligibility Criteria
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 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 uncontrolled blood pressure.
- Subject taking immunosuppressant.
- Subject with known or suspected hypersensitivity to any components of the APX-115 formulation.
- Clinically significant abnormal laboratory findings at screening.
- History of drug or alcohol abuse within 1 year prior to screening.
- 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.
- Clinically significant electrocardiogram (ECG) abnormalities.
- 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.
- 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.
- Positive hepatitis B surface antigen.
- 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.
Key Trial Info
Start Date :
May 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT06962098
Start Date
May 26 2025
End Date
June 30 2028
Last Update
July 18 2025
Active Locations (20)
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1
Korea University Ansan Hospital
Ansan-si, South Korea
2
Inje university Busan Paik Hospital
Busan, South Korea
3
Pusan National University Hospital
Busan, South Korea
4
SoonChunHyang University Hospital Cheonan
Cheonan, South Korea