Study to Investigate Renal Functional Reserve in Healthy Participants and in Participants With Impaired Renal Function.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Maximun kidneyfunction determined by measurement of creatinine clearance (mGFRCR)
研究概览
简要总结
The main purpose of this study is to investigate how reliable a test assessing the renal functional reserve (RFR) and the maximum glomerular filtration rate (maxGFR) are. MaxGFR and RFR assessments are repeated twice at 1-month intervals. If precise, this test may improve the measure of kidney function and be useful in future studies for people with chronic kidney problems.
To do this, the researchers will collect and analyze information about kidney function from up to 50 adults, including healthy people and people with stable kidney problems. Each person will come to the study center for a screening visit and then three study days, each about a month apart. On each study day, participants will have blood and urine samples taken before and after drinking a protein shake. The tests will measure things like creatinine, cystatin C, and other markers in the blood and urine to see how the kidneys are working. The study will also record basic health information, weight, blood pressure, and any medicines being taken.
The study will last about 2 to 2.5 months for each participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •Participant must be 18 to 75 years of age inclusive, at the time of signing the ICF.
- •Stable medical condition defined as no new drug or other treatment prescribed for a chronic condition within 60 days prior to Study Day
- •Body weight between 50 and 100 kg.
- •Female Participants: A participant is eligible to participate if not pregnant or breastfeeding. If a urine test cannot be confirmed as negative at screening (e.g., an ambiguous result), the participant must be excluded from participation.
排除标准
- •Recent surgical intervention within 60 days prior to Study Day
- •New clinical diagnosis established within 60 days prior to Study Day
- •New drug prescription within 60 days prior to Study Day
- •Relevant change in severity of any medical condition within 60 days prior to Study Day 1, e.g. disease flare.
- •Known congenital amino acid metabolism disorders.
- •Severe hypersensitivity to milk products.
- •Known liver cirrhosis.
- •Regular use of non-steroidal anti-inflammatory drugs (NSAIDs).
- •Impaired kidney function with eGFR <30 mL/min/1.73m2
研究组 & 干预措施
Group 1
干预措施: No investigational study intervention (Other)
结局指标
主要结局
Maximun kidneyfunction determined by measurement of creatinine clearance (mGFRCR)
时间窗: Day 1, 28 and 56
Renal functional reserve by measurement of creatinine clearance (mGFRCR)
时间窗: Day 1, 28 and 56
次要结局
- Maximum kidney function and renal functional reserve derived from serum creatinine-based eGFR (eGFRSCR)(Day 1, 28 and 56)
- Maximum kidney function and renal functional reserve derived from serum cystatin C-based eGFR (eGFRCYS)(Day 1, 28 and 56)
- Maximum kidney function and renal functional reserve derived from serum creatinine-based and serum cystatin C-based eGFR (eGFRSCR-CYS)(Day 1, 28 and 56)
- Maximum creatinine clearance and renal functional reserve derived from plasma PENK-based eGFR (eGFRPENK)(Day 1, 28 and 56)