Measurement of Renal Functional Reserve With Urinary Clearance of Cold Iothalamate Before and After an Oral Protein Load
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Change in glomerular filtration rate after ingestion of protein
研究概览
简要总结
Single arm physiological study to measure renal functional reserve as a biomarker of kidney function and health
详细描述
The investigators will measure glomerular filtration rate using urinary clearance of cold iothalamate before and after an oral protein load in patients with chronic kidney disease and healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Estimated GFR >30 mL/min/1.73m2
排除标准
- •Allergy to iothalamate, shellfish or iodine
- •Use of metformin or amiodarone
- •Inability to maintain a stable regimen of medications which affect GFR for > one week prior to participation (e.g. non-steroidal anti-inflammatory drugs, angiotensin converting enzyme inhibitors, angiotensin receptor blockers)
- •Use of medications which directly affect elimination of creatinine (e.g. cimetidine and trimethoprim)
- •Acute exacerbation of asthma or chronic obstructive pulmonary disease within 3 months requiring hospitalization or oral steroid therapy
- •Inadequate intravenous access
- •Severe anemia (Hct <21%)
- •Acute kidney injury (rise in creatinine to ≥1.5 times the previous baseline or by ≥ 0.3 mg/dL on most recent labs prior to enrollment)
- •History of contrast-induced nephropathy
- •Hyperthyroidism
- •Pheochromocytoma
- •Sickle cell disease
- •Urinary retention or incontinence
- •Status post organ transplant
- •Pregnancy or active breast feeding
- •Cognitive impairment with inability to give consent
- •Institutionalized status
结局指标
主要结局
Change in glomerular filtration rate after ingestion of protein
时间窗: Single full-day clinic visit: Repeated glomerular filtration rate measurements are to be performed over the course of the day at a single study visit for each participant.
Short term-changes in the glomerular filtration rate will be measured before and after ingestion of oral protein
次要结局
未报告次要终点
研究者
Sushrut S Waikar
Constantine L. Hampers, MD Distinguished Chair in Renal Medicine
Brigham and Women's Hospital