NCT06962098招募中2 期
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
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 186
- 试验地点
- 20
- 主要终点
- Efficacy endpoint: Urine Albumin-Creatinine Ratio
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Isuzinaxib 400 mg
Active Comparator
Subject will receive the 400 mg of Isuzinaxib.
干预措施: Isuzinaxib (Drug)
Isuzinaxib 200 mg
Active Comparator
Subject will receive the 200 mg of Isuzinaxib.
干预措施: Isuzinaxib (Drug)
Placebo
Placebo Comparator
Subject will receive the Placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy endpoint: Urine Albumin-Creatinine Ratio
时间窗: Over 24 Weeks
Change in Urine Albumin-Creatinine Ratio from baseline through Week 24 in the Isuzinaxib treatment groups versus the placebo group
次要结局
- Efficacy endpoint: eGFR(Over 24 Weeks)
- Efficacy endpoint: Urine Albumin-Creatinine Ratio(Over 20 Weeks)
- Efficacy endpoint: Urine Albumin-Creatinine Ratio decrease(Over 24 Weeks)
- Efficacy endpoint: Incidence of Composite Renal Outcome(Over 24 Weeks)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](Over 24 Weeks)
- PK Endpoint: Pharmacokinetics(Over 24 Weeks)
研究者
研究点 (20)
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