NCT02232776

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 5, 2014

Completed
26 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

October 10, 2018

Status Verified

July 1, 2017

Enrollment Period

2.2 years

First QC Date

September 3, 2014

Last Update Submit

October 8, 2018

Conditions

Glomerulonephritis, IGA

Keywords

LosartanIg A nephropathychildrenproteinuria

Outcome Measures

Primary Outcomes (1)

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

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

    24weeks

Secondary Outcomes (3)

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

    24 weeks

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

    24 weeks

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

    24 weeks

Study Arms (1)

Losartan treatement

EXPERIMENTAL

All patients had received losartan treatment for 24 weeks.

Drug: Losartan

Interventions

LosartanDRUG

Dose of Losartan : 0.7mg/kg once daily.

Also known as: Cozaar
Losartan treatement

Eligibility Criteria

Age24 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Children's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Glomerulonephritis, IGAProteinuria

Interventions

Losartan

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System DiseasesUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Study Officials

  • Hee Gyung Kang, Ph.D

    Seoul National University Children's Hospital Departments of Pediatrics

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2014

First Posted

September 5, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2016

Study Completion

April 1, 2017

Last Updated

October 10, 2018

Record last verified: 2017-07

Locations

KR(1)