A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Phase 2 Study to Evaluate the Safety and Renal Efficacy of Baricitinib in Patients With Diabetic Kidney Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Change From Baseline in Urinary Albumin/Creatinine Ratio (UACR) at Week 24
研究概览
简要总结
This is a dose ranging study to evaluate the safety and efficacy of baricitinib in the treatment of participants with mild to moderate diabetic kidney disease.
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
- Double (Participant, Investigator)
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
- •Participants with Type 2 diabetes treated with at least one antihyperglycemic medicine for 12 months
- •Have diabetic kidney disease and receiving one of two specific medicines used to treat high blood pressure or diabetic kidney disease for at least 3 months
- •Estimated Glomerular Filtration Rate (eGFR) of 25 to 70 milliliter per minute per 1.73 square meter (mL/min/1.73 m²) (as determined by the Chronic Kidney Disease Epidemiology Collaboration equation) and a urinary albumin/creatinine ratio (UACR) >300 milligram per gram (mg/g) and <5000 mg/g
排除标准
- •Too high blood pressure when you enter the study
- •Some specific medicines used to treat high blood pressure or diabetic kidney disease
- •Frequent high blood glucose levels
- •Renal transplant or past history of dialysis
- •Nonsteroidal anti-inflammatory drugs (NSAIDs)
- •Had a special X-ray in the past 30 days which involved also receiving an injection of dye into the vein
- •Major surgery within 8 weeks of study entry or will require major surgery during the study
- •Some types of vaccination
- •Shingles or currently have symptoms of a cold sore
- •Serious viral, bacterial, fungal, or parasitic infection, or a urinary infection, Tuberculosis (TB)
- •Human immunodeficiency virus (HIV) infection- the virus that causes Acquired immunodeficiency syndrome (AIDS)
- •Have or had some blood disorders, enlarged lymph glands or spleen, or some cancers.
- •Serious circulatory, breathing, liver, stomach or bowel problems, neurological or psychiatric disorders
- •Heart attack or heart failure, or a stroke
- •Other serious disorders or illnesses
- •Electrocardiogram (ECG) heart trace abnormalities
- •Alcohol or illegal drug abuse
- •Donated more than 500 mL of blood in the last 30 days (no blood donations allowed during the study)
- •Pregnant or breastfeeding
研究组 & 干预措施
Placebo
Administered orally, given as three placebo tablets in the morning and one placebo tablet in the evening for 24 weeks.
干预措施: Placebo (Drug)
Baricitinib 0.75 mg/0.5 mg QD
Administered orally, 0.75 mg given as one 0.75 mg tablets and two placebo tablets in the morning and one placebo tablet in the evening for 24 weeks or 0.5 mg given as one 0.5 mg tablet and two placebo tablets in the morning and one placebo tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.
干预措施: Baricitinib (Drug)
Baricitinib 0.75 mg/0.5 mg QD
Administered orally, 0.75 mg given as one 0.75 mg tablets and two placebo tablets in the morning and one placebo tablet in the evening for 24 weeks or 0.5 mg given as one 0.5 mg tablet and two placebo tablets in the morning and one placebo tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.
干预措施: Placebo (Drug)
Baricitinib 0.75 mg/0.5 mg BID
Administered orally, 0.75 mg given as one 0.75 tablet and 2 placebo in the morning and one 0.75 mg tablet in the evening for 24 weeks or 0.5 mg given as one 0.5 mg tablet and two placebo tablets in the morning and one 0.5 mg tablet in the evening. Placebo tablets given to maintain blind.
干预措施: Baricitinib (Drug)
Baricitinib 0.75 mg/0.5 mg BID
Administered orally, 0.75 mg given as one 0.75 tablet and 2 placebo in the morning and one 0.75 mg tablet in the evening for 24 weeks or 0.5 mg given as one 0.5 mg tablet and two placebo tablets in the morning and one 0.5 mg tablet in the evening. Placebo tablets given to maintain blind.
干预措施: Placebo (Drug)
Baricitinib 1.5 mg/1 mg
Administered orally, 1.5 mg given as two 0.75 mg tablets and 1 placebo tablet in the morning and one placebo tablet in the evening for 24 weeks or 1 mg tablet and two placebo tablets in the morning and one placebo tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.
干预措施: Baricitinib (Drug)
Baricitinib 1.5 mg/1 mg
Administered orally, 1.5 mg given as two 0.75 mg tablets and 1 placebo tablet in the morning and one placebo tablet in the evening for 24 weeks or 1 mg tablet and two placebo tablets in the morning and one placebo tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.
干预措施: Placebo (Drug)
Baricitinib 4 mg/2.75 mg
Administered orally, 4 mg given as one tablet and 2 placebo tablets in the morning and one placebo tablet in the evening for 24 weeks or 2.75 mg given as two 1 mg tablets and one 0.75 mg tablet in the morning and one placebo tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.
干预措施: Baricitinib (Drug)
Baricitinib 4 mg/2.75 mg
Administered orally, 4 mg given as one tablet and 2 placebo tablets in the morning and one placebo tablet in the evening for 24 weeks or 2.75 mg given as two 1 mg tablets and one 0.75 mg tablet in the morning and one placebo tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Urinary Albumin/Creatinine Ratio (UACR) at Week 24
时间窗: Baseline, Week 24
UACR is a potential marker of chronic kidney disease, calculated as a ratio of Urinary Albumin and Urinary Creatinine. The least squares mean (LS mean) are from mixed model repeated measures (MMRM) analyses which include treatment, baseline estimated Glomerular Filtration Rate (eGFR) group (higher: 50 to 70 mL/min/1.73m² and lower: 25 to \<50 mL/min/1.73m²), visit, treatment-by-visit interaction, baseline UACR, and baseline UACR-by-visit interaction.
次要结局
- Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 24(Baseline, Week 24)
- Change From Baseline in Urinary Monocyte Chemotactic Protein 1 (MCP-1)/Creatinine Ratio(Baseline, Week 24)
- Change From Baseline in Creatinine Clearance at Week 24(Baseline, Week 24)
- Pharmacokinetics (PK): Area Under the Concentration-Time Curve at Steady State (AUC,ss)(Weeks 2 and 4 (1-2 hours postdose), 8 (3-6 hours postdose), 12 (in fasted state), 16 and 20 (6-9 hours postdose), 24 (in fasted state))