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

Phase 3

Completed

• Conditions: Proteinuria
• Interventions: Drug: Losartan; Drug: Placebo

• Registration Number: NCT02232763
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-03
• Study First Submitted QC: 2014-09-03
• Study First Posted: 2014-09-05
• Primary Completion: 2016-07
• Study Completion: 2016-09
• Status Verified: 2017-07
• Last Update Submitted: 2018-10-08
• Last Update Posted: 2018-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Losartan	Losartan	12 weeks of losartan or placebo with crossover to the other
Placebo	Placebo	12 weeks of losartan or placebo with crossover to the other

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Children's Hospital; 🇰🇷 Seoul, Korea, Republic of