NCT00345137已完成1 期
Phase 1 Study of Systemic Effects of Ng-Monomethyl-L-Arginine on Renal Hemodynamics in Patients With Polycystic Kidney Disease and Chronic Glomerulonephritis
Regional Hospital Holstebro0 个研究点目标入组 75 人开始时间: 2006年6月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
研究概览
简要总结
The study tests the hypothesis that systemic and renal nitric oxide availability is changed in polycystic kidney disease and chronic glomerulonephritis.
详细描述
In a randomized, placebo controlled design, the effects of systemic treatment with monomethyl-L-arginine are studied on:
- renal hemodynamics
- renal sodium excretion and lithium clearance
- blood pressure and heart rate
- plasma levels of vasoactive hormones
in patients with adult polycystic kidney disease and chronic glomerulonephrits. The results are compared with a group of healthy control subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy controls
- •Age 20 to 60 years
- •Both men and women
- •Weight below 100 kg
- •Normal clinical examination and laboratory screening
- •Fertile women only if using contraception
- •Informed consent according to the regulations of the local etics committee
- •Chronic glomerulonephritis
- •Biopsy veryfied chronic glomerulonephritis
- •P-creatinine < 250 µmol/L
- •Weight below 100 kg
- •Age 20 to 60 years
- •Both men and women
- •Informed consent according to the regulations of the local etics committee
- •Adult polycystic kidney disease (APKD)
- •Diagnosis of APKD by family history and renal ultrasound or renal angiography
- •P-creatinine < 250 µmol/L
- •Weight below 100 kg
- •Age 20 to 60 years
- •Both men and women
- •Informed consent according to the regulations of the local etics committee
排除标准
- •Healthy controls
- •History or clinical evidence of diseases of the heart and blood vessels, kidneys, liver and pancreas, endocrine organs, lungs, neoplastic disease, myocardial infarction or cerebrovascular insult as evaluated by clinical examination and laboratory screening
- •Current medication
- •Drugs or alcohol abuse
- •Pregnancy
- •Previously within one year received more than 0.2 mSV radioactive treatment or diagnostic substances
- •Donation of blood less than 1 month before the experiments
- •Chronic glomerulonephritis
- •Apart from chronic glomerulonephritis and hypertension no history of diseases of the heart and blood vessels, liver and pancreas, endocrine organs, lungs, myocardial infarction, cerebrovascular insult or neoplastic disease.
- •Patients with nephrotic syndrome or secondary glomerulonephritis
- •Current medication other than antihypertensive therapy
- •Drugs or alcohol abuse
- •Pregnancy
- •Previously within one year received more than 0.2 mSV radioactive treatment or diagnostic substances
- •Adult polycystic kidney disease
- •Apart from APKD and hypertension no history of diseases of the heart and blood vessels, liver and pancreas, endocrine organs, lungs, myocardial infarction, cerebrovascular insult or neoplastic disease.
- •Current medication other than antihypertensive therapy
- •Drugs or alcohol abuse
- •Pregnancy
- •Previously within one year received more than 0.2 mSV radioactive treatment or diagnostic substances
研究者
相似试验
已完成
1 期
Effects of Inhibition of NO-Synthesis on Renal Hemodynamics and Sodium Excretion in Patients With Essential Hypertension and Healthy ControlsHypertensionNCT00345150Regional Hospital Holstebro30
已完成
1 期
L-NMMA Dose-response Study in Healthy SubjectsHealthyNCT01070940Regional Hospital Holstebro12
已完成
2 期
An exploratory study of the biologic effects of nivolumab and nivolumab in combination with ipilimumab treatment in subjects with advanced melanoma (unresectable or metastatic).Advanced (unresectable or metastatic) melanoma10040900NL-OMON41223Bristol-Myers Squibb10
已完成
1 期
Effects of Acute L-NMMA Treatment on Renal Hemodynamics and Vasoactive Hormones in Patients With Congestive Heart FailureCongestive Heart FailureNCT00344734Regional Hospital Holstebro30
进行中（未招募）
不适用
Effects of adjunctive Mononitrate, an angin medication, in patients with a Schizophrenia diagnosis.SchizophreniaRBR-8kyq7gHospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP