NCT01712061已完成2 期
A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Study To Evaluate The Efficacy And Safety Of Once-daily Administration Of A Chemokine Ccr2/5 Receptor Antagonist (Pf-04634817) In Adults With Type 2 Diabetes And Overt Nephropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 226
- 试验地点
- 138
- 主要终点
- Percent Reduction From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12
研究概览
简要总结
The study hypothesis under test is that administration of a CCR2/5 antagonist to subjects with type 2 diabetes and overt nephropathy will result in a reduction in urinary albumin, a surrogate for improved glomerular filtration.
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
- •Clinical diagnosis of type 2 diabetes together with stages 2, 3a, 3b or 4 CKD, based on an eGFR of 20-75 mL/min/1.73m
- •Evidence of persistent, overt albuminuria; defined as a UACR >=300 mg/g (>=33.9 mg/mmol) or UPCR >=390 mg/g (44.1 mg/mmol), or equivalent, for 3 months or longer.
- •Stable background therapy of RAAS inhibition (ie, an ACE inhibitor and/or an ARB, which may also include an aldosterone antagonist in double RAAS but not triple RAAS inhibitor therapy) for at least 3 months before screening and to be maintained for the duration of the study.
排除标准
- •Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD.
- •Subjects who are diagnosed with autosomal dominant polycystic kidney disease (ADPCKD), severe peripheral vascular disease (PVD) or obstructive uropathy.
研究组 & 干预措施
Arm 1 PF-04634817
Active Comparator
干预措施: PF-04634817 (Drug)
Arm 2 Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Reduction From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12
时间窗: Baseline and Week 12
The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.
次要结局
- Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) at Weeks 4, 8, 12 and 16(Baseline, Weeks 4, 8, 12 and 16)
- Change From Baseline in eGFR Using Cystatin Formula at Weeks 12 and 16(Baseline, Week 12, and Week 16)
- Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12(1, 2, 4 hours post-dose on Day 1; 2 hours post-dose on Weeks 1, 4, 8 and 12)
- Change From Baseline in UACR at Weeks 4, 8 and 16(Baseline, Weeks 4, 8 and 16)
- Change From Baseline in Serum Creatinine at Weeks 1, 4, 8, 12 and 16(Baseline, Week 1, 4, 8, 12 and 16)
- Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 4, 8, 12 and 16(Baseline, Weeks 4, 8, 12 and 16)
- Change From Baseline in Serum Cystatin C at Weeks 12 and 16(Baseline, Week 12, and Week 16)
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Abbreviated Modified Diet in Renal Disease (MDRD) Formula at Weeks 1, 4, 8, 12 and 16(Baseline, Week 1, 4, 8, 12 and 16)
研究者
研究点 (138)
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