Childhood idiopathic nephrotic syndrome (NS)
Conditions
Interventions
Product Name: amiloride
Product Code: C03DB01
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Aarhus University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): . Edema scores - Renin/aldosteron in blood/urine - PLasminogen/plasmin in urine - uPA concenration in urine Amilorid concentration in urine - Urines ability to genere current in patch clamp experiments;Timepoint(s) of evaluation of this end point: Day 1, 3, 5 and 30 | — |
Countries
Denmark
Contacts
Public ContactDepartment of Pediatrics
Aarhus University Hospital
Outcome results
None listed