Efficacy and Safety of Losartan in Pediatric Chronic Kidney Disease With Tubular Proteinuria

Seoul National University Hospital58 enrolled

Overview

The investigators hypothesize that using Losartan would help decrease proteinuria in pediatric chronic kidney disease with tubular proteinuria.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Proteinuria

Interventions

LosartanDRUG

12 weeks of losartan or placebo with crossover to the other

PlaceboDRUG

12 weeks of losartan or placebo with crossover to the other

Eligibility

Sex: ALLMin age: 24 MonthsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Children's Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

the change in urinary protein-creatinine ratio from baseline to the end of 12 weeks

Change in urinary protein excretion, determined as urinary Protein-creatinine ratio compared to baseline, after 12 weeks of treatment

Time frame: 12 weeks

Secondary Outcomes

the change in urinary albumin-creatinine ratio from baseline to the end of study

Change in urinary albumin excretion, determined as urinary albumin-creatinine ratio compared to baseline, after 12 weeks of treatment

Time frame: 12 weeks

the proportion of patients wifh more than 50% decrease of urinary protein-creatinine ratio

number of patients with wifh more than 50% decrease of urinary protein-creatinine ratio compared to baseline, after 12 weeks of treatment

Time frame: 12 weeks

the change in urinary beta2-microglobulin-creatinine ratio from baseline to the end of study

Change in urinary beta2-microglobulin--creatinine ratio compared to baseline, after 12 weeks of treatment

Time frame: 12 weeks

the change in urinary NAG-creatinine ratio from baseline to the end of study

Change in urinary NAG-creatinine ratio compared to baseline, after 12 weeks of treatment

Time frame: 12 weeks

Data from ClinicalTrials.gov

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