Chronic proteinuric nephropathies
Conditions
Interventions
Product Name: Hidroclorotiazida
Pharmaceutical Form: Tablet
INN or Proposed INN: Hidroclorotiazida
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Product Name
Sponsors
Fundación para la Investigación Biomédica del Hospital 12 de Octubre
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to compare the percentage reduction of albuminuria/proteinuria in patients with proteinuric chronic kidney disease of any etiology treated with hydrochlorothiazide vs amiloride+hydrochlorothiazide vs spironolactone.;Secondary Objective: To evaluate the percentage of proteinuric patients reduces by 30 and 50% in each group of diuretic therapy. Knowing renal function (creatinine clearance and MDRD-4) at the beginning and end of each group of diuretic therapy. Determine changes in blood pressure in each treatment group. Determine changes in plasma electrolytes (sodium, potassium) with different types of diuretics. To determine the changes in urinary electrolytes (sodium, potassium) in each group of diuretic therapy. Determine changes in plasma renin and aldosterone with different types of diuretics. To evaluate the safety and tolerability of different treatment regimens.;Primary end point(s): The primary efficacy parameter is to compare the percentage reduction of albuminuria / proteinuria in patients with proteinuric renal disease of any etiology treated with hydrochlorothiazide versus hydrochlorothiazide + amiloride versus spironolactone.;Timepoint(s) of evaluation of this end point: The primary end point will be evaluated for each treatment, at baseline and at the end of each treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Percentage of patients with a reduction in proteinuria over 25%. 2. Determination of renal function assessed by serum creatinine and GFR determined by MDRD-4 after each treatment period. 3. Changes in weight and BMI after each treatment period. 4. Changes in SBP and DBP after each treatment period. 5. Percentage of patients with hyperkalemia (K> 5.5 mEq / L) during the treatment period. 6. Changes in plasma renin and aldosterone after each treatment period. 7. Changes in uric acid levels after each treatment period. 8. Changes in urinary sodium values ??after each treatment period. 9. Percentage of patients who abandon treatment. 10. Percentage of patients with adverse effects in each treatment group.;Timepoint(s) of evaluation of this end point: All of them will be evaluated for each treatment, at baseline and at the end of each treatment. | — |
Countries
Spain
Contacts
Public ContactServicio de Nefrología
Hospital Universitario 12 Octubre
Outcome results
None listed