Efficacy and Safety of Losartan in Children With Ig A Nephropathy

NCT ID: NCT02232776

Last Updated: 2018-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Glomerulonephritis, IGA

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Losartan treatement

All patients had received losartan treatment for 24 weeks.

Group Type EXPERIMENTAL

Losartan

Intervention Type DRUG

Dose of Losartan : 0.7mg/kg once daily.

Interventions

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Losartan

Dose of Losartan : 0.7mg/kg once daily.

Intervention Type DRUG

Other Intervention Names

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Cozaar

Eligibility Criteria

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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
Minimum Eligible Age

24 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Food and Drug Safety, Korea

OTHER_GOV

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hee Gyung Kang, Ph.D

Role: STUDY_CHAIR

Seoul National University Children's Hospital Departments of Pediatrics

Locations

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Seoul National University Children's Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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Losartan_IgA_2014

Identifier Type: -

Identifier Source: org_study_id

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