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: 8.1 Level: SOC Classification code 10038359 Term: Renal and urinary disorders
Conditions
Interventions
Pharmaceutical Form:
Sponsors
Organisation name was not entered
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Denmark
Outcome results
None listed