NCT04179630已完成1 期
A Phase 1, Single-center, Open Label, Parallel Group Study to Evaluate the Pharmacokinetics, Safety & Tolerability of a Single Dose of Aldafermin (NGM282) in Subjects With Impaired Renal Function
NGM Biopharmaceuticals, Inc2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2019年11月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Area under the concentration-time curve from time zero extrapolated to infinity (AUC 0-infinity) of aldafermin (Day 1 through Day 4)
研究概览
简要总结
This is a single-center evaluation of Aldafermin (NGM282) in an open-label, single-dose and parallel group study in participants with Impaired Renal Function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current diagnosis of stable chronic kidney disease and eGFR, as assessed by the Modification of Diet in Renal Disease (MDRD) estimate:
- •Mild renal impairment: eGFR 60-89 mL/min/1.73m²
- •Moderate renal impairment: eGFR 30-59 mL/min/1.73m²
- •Severe renal impairment: eGFR < 30 mL/min/1.73m²
- •Healthy control subjects with normal renal function will be matched (age ± 10 years; sex, race, BMI ± 15%) to their respective subject in the impaired renal function groups and have eGFR ≥90 mL/min/1.73m . Healthy control subjects should have no systemic chronic disease.
- •Males and Females age 18-75
- •Body mass index (BMI) 25-40 kg/m²
排除标准
- •Renal allograft recipients
- •History of renal cell carcinoma or any history of metastatic disease involving the kidney
- •End Stage Renal disease, requiring or not requiring dialysis
- •Subject requiring or anticipated requirement of dialysis within 3 months of study entry
- •Diagnosis of acute kidney injury/acute renal failure, or hospitalization for kidney related issue within 3 months of Screening
- •Any renal disease or related condition actively being treated other than chronic kidney disease
- •Any acute disease or condition being treated by medical therapy (prescription or over the counter) known to possibly impact renal function within 2 weeks of Screening
- •History of treatment for a chronic condition with a medication that is known to have nephrotoxic potential, and after treatment, renal function/status has not been fully evaluated
- •Uncontrolled hypertension
- •Uncontrolled diabetes
结局指标
主要结局
Area under the concentration-time curve from time zero extrapolated to infinity (AUC 0-infinity) of aldafermin (Day 1 through Day 4)
时间窗: 12 Days
Maximum observed plasma concentration (Cmax) of aldafermin (Day 1 through Day 4)
时间窗: 12 Days
次要结局
- Type and frequency of Adverse Events (Day 1 through Day 11)(12 Days)
研究者
研究点 (2)
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