Amilorid treatment of nephrotic edema
Phase 1
- Conditions
- Childhood idiopathic nephrotic syndrome (NS)Therapeutic area: Not possible to specify
- Registration Number
- EUCTR2015-001946-26-DK
- Lead Sponsor
- Aarhus University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- First episode of NS
- Age 1 to 15 yrs
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- Relapse of NS or secondare NS
- Fever
- Dehydration
- Treatment with prednisolon/diuretics 1 mth prior inclusion
- PLasma K above 5,5 mmol/l
- Decreased renal function
- Known allergy to amilorid
- Pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: NS is characterized by severe weight gain and edema formation. Recently, it was justified that the edema was a result of activation of the epithelial sodium channel (ENaC) in the kidneys and ENaC is blocked by amilorid.<br>The objective of this study is to investigate if amilorid is superior to placebo treating the edema observed in NS ;Secondary Objective: not applicable;Primary end point(s): Patients weight (kg) and sodium concentration in urine (mmol/L);Timepoint(s) of evaluation of this end point: Day 1, 5, 10 and 30
- Secondary Outcome Measures
Name Time Method Secondary end point(s): . Edema scores<br>- Renin/aldosteron in blood/urine<br>- PLasminogen/plasmin in urine<br>- uPA concenration in urine<br>Amilorid concentration in urine<br>- Urines ability to genere current in patch clamp experiments;Timepoint(s) of evaluation of this end point: Day 1, 3, 5 and 30