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OpenTrials
Completed

NCT Number: NCT02232763

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

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

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Key information

Conditions

Proteinuria Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

24 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Children's Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Losartan

Drug

12 weeks of losartan or placebo with crossover to the other

Other names: Cozaar

Placebo

Drug

12 weeks of losartan or placebo with crossover to the other

Primary outcomes

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

    Time frame: 12 weeks

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

Secondary outcomes

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

    Time frame: 12 weeks

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

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

    Time frame: 12 weeks

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

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

    Time frame: 12 weeks

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

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

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Ministry of Food and Drug Safety, Korea

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 5, 2014
Registry last updated
Oct 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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