Proteinuria
Conditions
Keywords
Losartan, children, proteinuria
Brief summary
The investigators hypothesize that using Losartan would help decrease proteinuria in pediatric chronic kidney disease with tubular proteinuria.
Detailed description
Children with tubular proteinuria (urine protein to creatinine ratio \> 0.3 mg/mg) were randomly assigned in 1:1 ratio to losartan or placebo treatment for 12 weeks, then crossed over to the opposite intervention for another three months after a washout period of 2 weeks. The primary outcome is the change in urinary protein-creatinine ratio from baseline to the end of 12 weeks. Efficacy of losartan in children with CKD with tubular proteinuria was also investigated with additional retrospective review of medical record.
Interventions
DRUGLosartan
12 weeks of losartan or placebo with crossover to the other
DRUGPlacebo
12 weeks of losartan or placebo with crossover to the other
Sponsors
Ministry of Food and Drug Safety, Korea
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
24 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* Age: 2years or older and younger than 18 years * estimated GFR ≥ 30mL/min/m\^2 * Mean urinary protein-creatinine ratio \> 0.3 g/g from three first-morning spot urine collections * Renal hypoplasia/dysplasia, Reflux nephropathy, Polycystic kidney disease, Lowe syndrome, Dent disease, Tubulointerstitial nephritis, Nephronophthisis/Medullary cystic disease, Obstructive uropathy(including PUV, UPJ obstruction, UVJ obstruction)
Exclusion criteria
* hypertension * under dialysis or organ transplanted * bilateral renal artery stenosis or primary hyperaldosteronism * pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the change in urinary protein-creatinine ratio from baseline to the end of 12 weeks | 12 weeks | Change in urinary protein excretion, determined as urinary Protein-creatinine ratio compared to baseline, after 12 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the change in urinary albumin-creatinine ratio from baseline to the end of study | 12 weeks | Change in urinary albumin excretion, determined as urinary albumin-creatinine ratio compared to baseline, after 12 weeks of treatment |
| the proportion of patients wifh more than 50% decrease of urinary protein-creatinine ratio | 12 weeks | number of patients with wifh more than 50% decrease of urinary protein-creatinine ratio compared to baseline, after 12 weeks of treatment |
| the change in urinary beta2-microglobulin-creatinine ratio from baseline to the end of study | 12 weeks | Change in urinary beta2-microglobulin--creatinine ratio compared to baseline, after 12 weeks of treatment |
| the change in urinary NAG-creatinine ratio from baseline to the end of study | 12 weeks | Change in urinary NAG-creatinine ratio compared to baseline, after 12 weeks of treatment |
Countries
South Korea
Outcome results
None listed