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临床试验/NCT06572215
NCT06572215招募中不适用

DYNAMic Renal Assessment: NOvel Methods to Assess KIDNEY Functional Reserve

King's College Hospital NHS Trust1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2023年12月14日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
44
试验地点
1
主要终点
Change in eGFR from baseline to 2hours after oral protein load

研究概览

简要总结

This is a feasibility study to assess new, more practical ways of measuring renal reserve.

详细描述

Quantification of glomerular filtration rate (GFR) over time is the standard assessment of kidney function. In clinical practice, the endogenous marker, 'serum creatinine' concentration, is used as a static assessment of kidney function to estimate GFR. However, serum creatinine fails to increase until at least 50% of kidney tissue is lost,[2] thus is an inadequate indicator of early CKD.

GFR like many other physiological processes is not static and augments temporarily to stimuli such as exercise and protein intake, by up to 25% from baseline in healthy individuals.[3] Similar to cardiac function stress tests which predict adverse outcomes, inability to respond to renal stressors or 'reduced renal reserve' has been demonstrated to occur prior to development of CKD (e.g. in patients with diabetes and previous acute kidney injury (AKI)) and is associated with vulnerability to future AKI, despite the presence of apparently normal kidney function measured by serum creatinine concentration.[4] Renal reserve is lost with progressive CKD,[4] and has also been demonstrated to relate to severity of histological lesions.[5]

Current measurements of renal reserve (stimulated increase in GFR due to augmented renal blood flow above basal fasting values) involve administration of a compound that is freely filtered by the glomerulus, unaffected by tubular function and is physiologically inert, with assessment before and after an oral protein load or amino acid infusion which induces arterial vasodilation, increasing renal blood flow and GFR

The study proposes a comparison of two novel methods of 'dynamic renal function testing' with renal reserve testing.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with sickle cell nephropathy, diagnosed clinically or histologically. Sickle Cell patients will be confirmed Hb SS and eGFR (CKD-EPI) ≥ 135 ml/min/1.73m2 OR
  • Previous living kidney donation
  • Age ≥ 4No contraindication or known allergy to any trial medications.
  • Willing and able to provide written informed consent

排除标准

  • Aged < 40
  • Unable or unwilling to provide informed consent
  • Breastfeeding or pregnant women
  • Patients involved in other interventional research studies.

研究组 & 干预措施

Healthy Participants

干预措施: Dapagliflozin (Drug)

Patients with hyperfiltration

干预措施: Dapagliflozin (Drug)

结局指标

主要结局

Change in eGFR from baseline to 2hours after oral protein load

时间窗: 2 hours

次要结局

未报告次要终点

研究者

发起方
King's College Hospital NHS Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

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