EUCTR2014-001973-15-DK进行中(未招募)不适用
Renal Handling of Water and Sodium in Autosomal Dominant Polycystic Kidney Disease.The effects of tolvaptan on renal handling of water and sodium , vasoactive hormones and central hemodynamics during baseline conditions and after inhibition of the nitric oxide system in patients with autosomal dominant polycystic kidney disease - TOPO
niversity Clinic in Nephrology and Hypertension, Department of Medical Research0 个研究点开始时间: 2014年6月27日最近更新:
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试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Caucasian men and women
- •2) Age between 18-65 years
- •3) ADPKD, diagnosed by genetic testing of PKD1 (>85%) or PKD2 mutations, or by ultrasonography:
- •a) patients with negative family history for ADKPD and more than 10 cysts in each kidney and no extrarenal or renal findings that suggest causes to cyst formation.
- •b) patients with positive family history for ADPKD:
- •15-39 yr of age and at least 3 or more unilateral or bilateral.
- •40-59 yr of age and 2 or more cysts in each kidney.
- •60 yr of age and at least 4 cysts in each kidney.
- •4) Kidney function corresponding to CKD stages 1-3(eGFR> 30 mL/min/1,73 m2)
- •5) BMI between 18.5 and 30 kg/m2.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Clinical signs of diseases in the heart, lungs, endocrine organs, brain or neoplastic disease, 2) clinically significant abnormalities in blood or urine sample at the inclusion 3) previous cerebrovascular insults, 4) previous clinical evidence for aneurysm 5) Alcohol or drug abuse, 6) smoking, 7) pregnancy or breastfeeding, 8) clinically significant changes in the electrocardiogram, 9) medication except antihypertensive agents and oral contraceptives.
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