The effect of aldosterone inhibition on proteinuria in patients with progressive renal disease.
- Conditions
- Patients with chronic nephropathy and proteinuria over 0,5 g/24 hrs are to be given an inhibitor of aldosterone. Theory tells that aldosterone plays an active role in nephropathy and if that can be inhibited patients with chronic renal diseases may prolong their pre-dialysis period of time.MedDRA version: 8.1Level: SOCClassification code 10038359Term: Renal and urinary disorders
- Registration Number
- EUCTR2006-004411-21-DK
- Lead Sponsor
- Organisation name was not entered
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 25
Age more than 18 years.
Acceptance from patients, gives of free will.
Proteinuria > 0,5 g/24 hours
Blood pressure is to be between 120-130/70-80 mmHg.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
diabetic nephropathia
GFR < 20 ml/min
p-potassium between 3,5 and 5,0 mmol/l
allergy to aldosteronereceptor antagonists
chronic liverinsufficiency
treatment with CYP3A4-inhibitors
treatment with lithium, ciclosporin, tacrolimus
inherited intolerance to galactose,
lactase insufficiency
glucose/galactose malabsorption
pregnancy
lactating
not using safe anti-conception
dementia or other psychiatric disorder, which disenables the person to understand the information
other serious non-renal chronic illness
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To reduce protein excretion via urine in patients with chronic renal disease.;Secondary Objective: To evaluate if there is a tendency to reduce proteinuria via aldosterone inhibition and to prolong pre-dialysis time for these patients.;Primary end point(s): Reduction in proteinuria after 8 weeks of treatment
- Secondary Outcome Measures
Name Time Method