Efficacy and Safety Study of Isuzinaxib in Subjects With DKD

Official title

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

Overview

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.

Interventions

• Drug Isuzinaxib
  Oral dosing regimen once daily
• Drug Placebo
  Oral dosing regimen once daily

Primary outcome measures

• Efficacy endpoint: Urine Albumin-Creatinine Ratio [Time frame: Over 24 Weeks]

Secondary outcome measures (6)

• Efficacy endpoint: eGFR [Time frame: Over 24 Weeks]
• Efficacy endpoint: Urine Albumin-Creatinine Ratio [Time frame: Over 20 Weeks]
• Efficacy endpoint: Urine Albumin-Creatinine Ratio decrease [Time frame: Over 24 Weeks]
• Efficacy endpoint: Incidence of Composite Renal Outcome [Time frame: Over 24 Weeks]
• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Time frame: Over 24 Weeks]
• PK Endpoint: Pharmacokinetics [Time frame: Over 24 Weeks]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

South Korea · 20 centers

• Korea University Ansan Hospital — Ansan-si
• Inje university Busan Paik Hospital — Busan
• Pusan National University Hospital — Busan
• SoonChunHyang University Hospital Cheonan — Cheonan
• Keimyung University Daegu Dongsan Hospital — Daegu
• Inje university Ilsan Paik Hospital — Goyang-si
• Hanyang University Guri Hospital — Guri-si
• Chung-Ang University Gwangmyeong Hospital — Gwangmyeong
• … and 12 more centers

Identifiers

NCT: NCT06962098 · APX-115-05

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗