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OpenTrials
Completed

NCT Number: NCT02232776

Efficacy and Safety of Losartan in Children With Ig A Nephropathy

The investigators hypothesize that using Losartan would help decrease proteinuria in controlling proteinuria in children with immunoglobulin A nephropathy.

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Key information

Conditions

Glomerulonephritis, IGA Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Pathological Conditions, Signs and Symptoms Proteinuria 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

Twenty nine patient with IgA nephropathy with proteinuria (urine protein to creatinine ratio > 0.3 mg/mg) were included in the study. All patients had received losartan treatment for 24 weeks. Changes in blood pressure, proteinuria, renal function, and biochemical parameters were prospectively evaluated before and at 4 weeks and 24 weeks.

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
  • Biopsy-proven Ig A Nephropathy
  • Estimated GFR ≥ 90mL/min/m^2
  • Mean urinary protein-creatinine ratio > 0.3 g/g from three first-morning spot urine collections

Exclusion criteria

  • hypertension
  • under dialysis or organ transplanted
  • bilateral renal artery stenosis
  • primary hyperaldosteronism
  • pregnant

Treatment and study plan

Losartan

Drug

Dose of Losartan : 0.7mg/kg once daily.

Other names: Cozaar

Primary outcomes

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

    Time frame: 24weeks

    Change in urinary protein excretion, determined as urinary protein-creatinine ratio compared to baseline, after 24 weeks of treatment.

Secondary outcomes

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

    Time frame: 24 weeks

    Change in urinary albumin-creatinine ratio compared to baseline, after 24 weeks of treatment.

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

    Time frame: 24 weeks

    Number of patients with wifh more than 50% decrease of urinary protein-creatinine ratio compared to baseline, after 24 weeks of treatment.

  3. the proportion of patients wifh urinary protein-creatinine ratio < 0.2 at the end of study

    Time frame: 24 weeks

    Number of patients wifh urinary protein-creatinine ratio < 0.2 after 24 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 Study Evaluating the Efficacy and Safety of Losartan in Children With Immunoglobulin A Nephropathy

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
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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