Randomised, open-label, crossover clinical trial to evaluate the antiproteinuric effect of three different types of diuretics (hydrochlorothiazide, amiloride and spironolactone) in patients with chronic proteinuric nephropathies.

Fundación para la Investigación Biomédica del Hospital 12 de Octubre0 个研究点开始时间: 2011年8月9日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Patients over 18 years and younger than 80 years.
•Patients with diabetes or chronic kidney disease with albuminuria among nondiabetic 300-3000 mg/24 h.
•Patients with stable kidney function during the last 3 months: serum creatinine <2.0 mg/dL or GFR> 60 mL/min/1.73 m2 (Grades 1 and 2 as K-DOQI guidelines included in Annex B of the Protocol).
•Patients who are receiving ACE inhibitors as a treatment prior antiproteinuric, ARA II or a combination of both.
•Patients who are able to understand the purpose and risks of the trial, which has been fully informed and have finally given written informed consent according to ICH-GCP. Patients who can not read and write but adequately understand verbal information provided by the investigator (or designee) verbal informed consent is granted against an independent witness signed the informed consent document.
•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 45
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 45

•Patients allergic or intolerant to hydrochlorothiazide, spironolactone or amiloride.
•Patients who are or have been involved in another clinical trial and / or are taking or have taken an experimental drug not registered in the last 28 days.
•Patients with poorly controlled blood pressure (SBP> 160 mm Hg or DBP> 100 mm Hg).
•Patients with a history of cardiovascular events (stroke, ischemic heart disease) in the last 6 months.
•Patients treated with steroids, NSAIDs or other immunosuppressants.
•Patients with a history of renovascular disease, obstructive uropathy, autoimmune diseases, cancer, drug abuse.
•Patients who are pregnant or breastfeeding.
•Pacients who do not sign informed consent.
•Low likelihood of compliance with scheduled visits in the protocol.

发起方

Fundación para la Investigación Biomédica del Hospital 12 de Octubre