NCT04419467已完成2 期
A Phase 2a, Double-blind, Randomized, Placebo-controlled, Proof of Concept Study of Vascular Endothelial Growth Factor (VEGF)-B Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 114
- 试验地点
- 37
- 主要终点
- Percent Change From Baseline in Urinary Albumin-to-creatinine Ratio (ACR)
研究概览
简要总结
This phase 2a, double-blind, randomized, placebo-controlled study will assess the efficacy, safety, tolerability, and pharmacokinetics (PK), of repeat doses of CSL346 in subjects with diabetic kidney disease (DKD) and albuminuria receiving standard of care treatment.
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects ≥ 25 years of age with a diagnosis of type 2 diabetes mellitus (T2DM)
- •Urinary ACR ≥ 150 mg/g
- •eGFR > 20 mL/min/1.73m2
- •Glycosylated HbA1c < 12%
排除标准
- •Current diagnosis of type 1 diabetes mellitus
- •History of acute kidney injury or chronic dialysis/renal transplant
- •Uncontrolled hypertension or class III / IV heart failure
- •Left ventricular ejection fraction < 50% by echocardiogram
- •Troponin-I > the upper reference limit
- •b-type natriuretic peptide > 200 pg/mL
- •ALT > 2x the upper limit of normal
研究组 & 干预措施
CSL346 (low dose)
Experimental
Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions
干预措施: CSL346 (Biological)
CSL346 (high dose)
Experimental
Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions
干预措施: CSL346 (Biological)
Placebo
Placebo Comparator
Administered as a single IV loading dose followed by SC infusions
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in Urinary Albumin-to-creatinine Ratio (ACR)
时间窗: Baseline up to Week 16
Data are presented as the geometric mean (GM) of percent change, which is calculated as the geometric mean of the Week 16 ACR to baseline, expressed as percent change from baseline.
次要结局
- Number of Subjects With Adverse Events of Special Interest (AESIs)(Up to 24 weeks)
- Observed Value and Mean Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)(Baseline up to 24 weeks)
- Percentage of Subjects With TEAEs(Up to 24 weeks)
- Observed Value and Mean Change From Baseline in Systolic Blood Pressure(Baseline up to 24 weeks)
- Percentage of Subjects With AESIs(Up to 24 weeks)
- Observed Value and Mean Change From Baseline in Serum Creatinine(Baseline up to 24 weeks)
- Observed Value and Mean Change From Baseline in Diastolic Blood Pressure(Baseline up to 24 weeks)
- Time to Reach Cmax in Serum (Tmax) After IV Loading Dose of CSL346 in Serum Samples(Up to 120 minutes after the IV loading dose for CSL346)
- Maximum Concentration (Cmax) After Intravenous (IV) Loading Dose of CSL346 in Serum Samples(Up to 120 minutes after the IV loading dose for CSL346)
- Cmax After First Subcutaneous (SC) Dose of CSL346 in Serum Samples(From Day 1 to Day 29)
- Area Under the Concentration-time Curve in First Dosing Interval(From Day 1 to Day 29)
- Number of Subjects With Treatment-emergent Adverse Events (TEAEs)(Up to 24 weeks)
- Tmax After First SC Dose of CSL346 in Serum Samples(From Day 1 to Day 29)
- Number of Subjects Positive for Anti-drug Antibodies(Weeks 4, 8, and 16)
- Trough Concentration After Each Dose(29 days after each dose)
- Percentage of Subjects Positive for Anti-drug Antibodies(Weeks 4, 8, and 16)
研究者
研究点 (37)
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