Antiproteinuric effect of three different types of diuretics in patients with chronic proteinuric nephrophaties.

• Conditions: Chronic proteinuric nephropathies; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-001929-24-ES
• Lead Sponsor: Fundación para la Investigación Biomédica del Hospital 12 de Octubre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified