NCT02232763

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2 days until next milestone

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
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 10, 2018

Status Verified

July 1, 2017

Enrollment Period

1.8 years

First QC Date

September 3, 2014

Last Update Submit

October 8, 2018

Conditions

Proteinuria

Keywords

Losartanchildrenproteinuria

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

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

    12 weeks

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

    12 weeks

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

    12 weeks

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

    12 weeks

Study Arms (2)

Losartan

EXPERIMENTAL

12 weeks of losartan or placebo with crossover to the other

Drug: Losartan

Placebo

EXPERIMENTAL

12 weeks of losartan or placebo with crossover to the other

Drug: Placebo

Interventions

LosartanDRUG

12 weeks of losartan or placebo with crossover to the other

Also known as: Cozaar
Losartan
PlaceboDRUG

12 weeks of losartan or placebo with crossover to the other

Placebo

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
  • 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)

You may not qualify if:

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

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

Proteinuria

Interventions

Losartan

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological 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
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2014

First Posted

September 5, 2014

Study Start

September 1, 2014

Primary Completion

July 1, 2016

Study Completion

September 1, 2016

Last Updated

October 10, 2018

Record last verified: 2017-07

Locations

KR(1)