NCT03926117已完成2 期
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 264
- 试验地点
- 46
- 主要终点
- Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) Levels
研究概览
简要总结
Patients with chronic kidney disease, who have evidence of systemic inflammation with increased cardiovascular risk, will be enrolled into this trial. The purpose of this trial is to determine a dose to select for a potential cardiovascular outcome trial with Ziltivekimab. Doses to be tested will be 7.5 mg, 15 mg and 30 mg subcutaneous monthly compared to placebo for six months.
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)
盲法说明
Matching placebo
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age
- •Stage 3-5 CKD
- •hs-CRP > 2.0 mg/L
- •Comply with contraception
排除标准
- •Low neutrophil count
- •Low platelet count
- •Spot urine protein to creatinine ration > 4000 mg/g
- •ALT/AST >2.5x ULN
- •TSAT < 10%
- •Positive TB test
- •Evidence of HIV, hepatitis B
- •Blind or illiterate
- •Expected to require blood transfusion
- •Thromboembolic event within 12-weeks
- •Evidence of active infection
- •Peptic ulcer disease, diverticulitis, inflammatory bowel disease
- •Uncontrolled hypertension
- •Planned coronary revascularization
- •Major cardiac surgery, CHF
- •Active malignancy, bone marrow or organ transplant
- •Allergy to study drug
- •Treatment with investigational drug, treatment with HIF stabilizer or ESA
- •Use of immunosuppressive drugs, systemic antibiotics
- •Breastfeeding, any other significant medical history
研究组 & 干预措施
Placebo
Placebo Comparator
Matching placebo
干预措施: Ziltivekimab (Biological)
Ziltivekimab 7.5 mg
Experimental
干预措施: Ziltivekimab (Biological)
Ziltivekimab 15 mg
Experimental
干预措施: Ziltivekimab (Biological)
Ziltivekimab 30 mg
Experimental
干预措施: Ziltivekimab (Biological)
结局指标
主要结局
Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) Levels
时间窗: Baseline (average of the hs-CRP value prior to randomization and day 1), week 13
Percent change from baseline in hs-CRP levels at week 13 are presented.
次要结局
- Percent Change From Baseline in Fibrinogen(Baseline (day 1), week 13)
- Percent Change From Baseline in Serum Amyloid A (SAA)(Baseline (average of the values at week -1 and day 1), week 13)
- Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding Events(From week 0 to week 32)
- Change in Systolic Blood Pressure (SBP)(Baseline (week 1), week 32)
- Change in Diastolic Blood Pressure (DBP)(Baseline (week 1), week 32)
- Change in Respiratory Rate(Baseline (week 1), week 32)
- Change in Bicarbonate, Chloride, Potassium, Sodium(Baseline (week 1), week 32)
- Change in Direct Bilirubin, Bilirubin, Calcium, Creatinine, Glucose, Phosphate and Urea Nitrogen(Baseline (week 1), week 32)
- Percentage of Participants With Any Treatment-emergent Adverse Events of Special Interest (AESI)(From week 0 to week 32)
- Change in Body Mass Index (BMI)(Baseline (week 1), week 24)
- Change in Temperature(Baseline (week 1), week 32)
- Change in Electrocardiogram (ECG)(Baseline (week -1), Week 24)
- Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious AEs (TESAEs), Severe Hematologic AEs, Severe Non-hematologic AEs, and AEs Leading to Drug Discontinuation(From week 0 to week 32)
- Change in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AAT) Levels(Baseline (week 1), week 32)
- Number of Participants With Anti-drug Antibodies (ADAs)(From week 0 to week 32)
- Change in Heart Rate(Baseline (week 1), week 32)
- Follicle Stimulating Hormone (FSH) Levels(Baseline (week -1))
研究者
研究点 (46)
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