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

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

Detailed Description
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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.

Official Title
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A Prospective, Randomized, Cross-over Study Evaluating the Efficacy and Safety of Losartan in Pediatric Chronic Kidney Disease With Tubular Proteinuria

Conditions
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Proteinuria

Intervention / Treatment
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* Drug: Losartan
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 24 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Losartan<br>12 weeks of losartan or placebo with crossover to the other | Drug: Losartan<br>* 12 weeks of losartan or placebo with crossover to the other<br>* Other names: Cozaar;|
| Experimental: Placebo<br>12 weeks of losartan or placebo with crossover to the other | Drug: Placebo<br>* 12 weeks of losartan or placebo with crossover to the other<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Losartan, children, proteinuria