EUCTR2006-004411-21-DK
Active, not recruiting
Phase 1
The effect of aldosterone inhibition on proteinuria in patients with progressive renal disease.
Organisation name was not entered0 sites25 target enrollmentDecember 20, 2006
ConditionsPatients 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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- 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.
- Sponsor
- Organisation name was not entered
- Enrollment
- 25
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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