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临床试验/NCT04363554
NCT04363554已完成不适用

The Kidneys Ability to Concentrate and Dilute Urine in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) or Other Cause of Chronic Renal Disease Compared to Healthy Volunteers

Regional Hospital Holstebro1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2017年9月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
51
试验地点
1
主要终点
free water clearance CH20 u-osm

研究概览

简要总结

The ability to concentrate and dilute urine is primarily regulated via vasopressin (AVP) dependent Aquaporin-2 water channels (AQP2 channels) in the kidney's collecting duct. Autosomal dominant polycystic kidney disease (ADPKD) is a common genetic disorder, characterized by the formation of cyst in the kidneys, causing gradual renal function-loss. Previous studies indicate that ADPKD patients have decreased urine concentration, higher plasma osmolality, and plasma AVP levels compared to healthy controls. Previous studies also indicate that ADPKD patients' dysregulated AVP is an important factor for the pathogenesis and progression of the disease. It is unclear whether ADPKD patients' ability to concentrate and dilute urine are different from those of other cause of chronic renal disease to the same degree. It is also unclear, what mechanisms cause the decreased ability to concentrate and dilute urine in chronic renal disease patients. The purpose of this trial is to investigate the difference in renal function during concentration and dilution test in a case-control, randomized, cross-examination study with ADKPD patients or other cause of chronic renal disease compared to healthy volunteers.

详细描述

The aim is to measure the difference in renal function, including kidney tubular function, blood pressure and vasoactive hormones in patients with Autosomal dominant polycystic kidney disease (ADPKD) or other chronic renal disease compared to healthy volunteers, during concentration and dilution test.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •ADPKD patients: -age >18 years, diagnosis with ADPKD, informed consent, contraception for fertile women
  • •Patients with chronic kidney disease: age >18 years, diagnosis with chronic kidney disease other then ADPKD, informed consent, contraception for fertile women
  • •Healthy volunteers: age >18 years, healthy, informed consent, contraception for fertile women

排除标准

  • •ADPKD patients: Renal transplantation, operation in the kidney, Diabetes mellitus, neoplastic conditions, pregnancy, breastfeeding, unwillingness to participate, intolerance towards urine dilution or urine concentration test, alcohol or medical abuse, BP >170/110 despite regulation, unacceptable side effects to background medication (antihypertensive medicine) during the trial.
  • •Patients with chronic kidney disease: Renal transplantation, operation in the kidney, Diabetes mellitus, medullary cystic kidney disease, lithium nephropathy, neoplastic conditions, pregnancy, nursing, unwillingness to participate, intolerance towards urine dilution or urine concentration test, alcohol or medical abuse, BP >170/110 despite regulation, unacceptable side effects to background medication (antihypertensive medicine) during the trial.
  • •Healthy volunteers: Arterial hypertension, significant clinical signs of heart, lungs, liver, kidneys, endocrine, brain or neoplastic disorders, alcohol or drug abuse, medical treatment, smoking, pregnancy or breastfeeding, smoking, clinically significant abnormal findings in blood, urine tests or electrocardiogram, blood donation within the last month before the examination date in the first trial sequence, intolerance to or unacceptable side effects of urine concentration and urine dilution test

研究组 & 干预措施

Urine dilution test

Other

Urine dilution test

干预措施: Fluid intake (Other)

Urine concentration test

Other

Urine concentration test

干预措施: Thirsting (Other)

结局指标

主要结局

free water clearance CH20 u-osm

时间窗: 5 hours

free water clearance (CH2O)

u-osm

时间窗: 4 hours

urine osmolality

次要结局

  • free water clearance(5 hours)

研究者

发起方
Regional Hospital Holstebro
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jesper Norgaard Bech

Head of University Clinic in Nephrology and Hypertension

Regional Hospital Holstebro

研究点 (1)

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