THE EFFECTS OF SITAXSENTAN ONCE DAILY DOSING ON PROTEINURIA, 24-HOUR BLOOD PRESSURE, AND ARTERIAL STIFFNESS IN SUBJECTS WITH CHRONIC KIDNEY DISEASE
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Change From Baseline in Mean 24-Hour Urine Total Protein Level at Week 6
研究概览
简要总结
This study is being conducted to evaluate sitaxsentan dosing in subjects with chronic kidney disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has stage 1-5 chronic kidney disease (CKD) as defined by the Kidney Disease Outcomes Quality Initiative (K/DOQI) with proteinuria, including any of the following aetiologies: immunoglobulin (IgA) nephropathy, polycystic kidney disease (PCKD), congenital abnormalities, reflux nephropathy, focal segmental glomerulosclerosis, minimal change nephropathy, and membranous nephropathy.
排除标准
- •Required peritoneal dialysis or haemodialysis.
- •Has kidney disease due to diabetes mellitus, vasculitis, systemic lupus erythematosus, or known renovascular disease; antiglomerular basement membrane disease; or is on immunosuppressive medication.
研究组 & 干预措施
Sitaxsentan
Sitaxsentan sodium 100 mg orally administered once daily (double blind arm)
干预措施: Open (Drug)
Nifedipine
Nifedipine 30 mg extended release tablets, orally administered once daily (open label arm)
干预措施: Nifedipine (Drug)
Placebo
Placebo for sitaxsentan, orally administered once daily (double blind arm)
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Mean 24-Hour Urine Total Protein Level at Week 6
时间窗: Baseline, Week 6
Mean urine total protein assessment included 24-hour urine collections to assess total protein excretion per 24 hours. Baseline was derived from an average of Week 0 (pre-dose) 24-hour urine collections prior to each treatment period. Week 6 was derived from an average of Week 6 24-hour urine collections for each treatment period.
次要结局
- Change From Baseline in Mean Systemic Arterial Blood Pressure (BP), Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 3 and 6(Baseline, Week 3 and 6)
- Change From Baseline in Carotid-Femoral Pulse Wave Velocity (PWV) at Week 3 and 6(Baseline, Week 3 and 6)