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 PHOSPHODIESTERASE 5 INHIBITOR (PF-00489791) IN ADULTS WITH TYPE 2 DIABETES AND OVERT NEPHROPATHY
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 256
- 试验地点
- 156
- 主要终点
- Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 12
研究概览
简要总结
PF-00489791 is an inhibitor of phosphodiesterase type 5. Our hypothesis is that PF-00489791 will enhance the relaxation of blood vessels within the kidney and so reduce blood pressure, improving renal function.
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
- •Male or female subjects greater than or equal to 18 years. Female subjects must be of non-child bearing potential.
- •Clinical diagnosis of type 2 diabetes together with stages 3a, 3b or 4 CKD, based on an eGFR of 25-59 mL/min/1.73m
- •Evidence of persistent, overt albuminuria; defined as a UACR greater than or equal to 300 mg/g (greater than or equal to 33.9 mg/mmol) for greater than 3 months.
排除标准
- •Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD.
- •Subjects with poorly controlled diabetes mellitus, defined as HbA1C >9%.
- •Subjects on combination ACE inhibitor/ARB therapy.
研究组 & 干预措施
PF-00489791
干预措施: PF-00489791 (Drug)
Placebo
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 12
时间窗: Baseline, Week 12 (Day 5, 6, 7)
UACR was ratio of albumin measured in urine (milligram) to creatinine measured in urine (millimole), reported in units milligram per millimole (mg/mmol). A decrease in UACR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to \[Day 5, 6 of Week 12\], and with last sample collected on the morning of scheduled clinic visit \[Day 7 of Week 12\]) were used to determine UACR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UACR.
次要结局
- Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 3, 6 and 16(Baseline, Week 3 (Day 5, 6, 7), Week 6 (Day 5, 6, 7), Week 16 (Day 5, 6, 7))
- Change From Baseline in Urinary Protein Creatinine Ratio (UPCR) at Week 3, 6, 12, and 16(Baseline, Week 3 (Day 5, 6, 7), Week 6 (Day 5, 6, 7), Week 12 (Day 5, 6, 7), Week 16 (Day 5, 6, 7))
- Change From Baseline in Serum Creatinine Concentration at Week 3, 6, 12, and 16(Baseline, Week 3, 6, 12, 16 (follow-up))
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 3, 6, 12, and 16(Baseline, Week 3, 6, 12, 16 (follow-up))
- Systolic, Diastolic and Mean Blood Pressure at Week 0, 3, 6, 12, and 16(Week 0, 3, 6, 12, 16 (follow-up))
- Change From Baseline in Urine Transforming Growth Factor (TGF) Beta-1 Concentration at Week 3, 6, 12, and 16(Baseline, Week 3, 6, 12, 16 (follow-up))
- Change From Baseline in Serum High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 12 and 16(Baseline, Week 12, 16 (follow-up))
- Change From Baseline in Serum Cystatin-C Concentration at Week 12 and 16(Baseline, Week 12, 16 (follow-up))
- Plasma Concentration Versus Time Summary of PF-00489791(Pre-dose at Day 1 of Week 0, 3, 6 and 12; 4 hours post-dose on Day 1 of Week 0, 3 and 6)