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Efficacy and Safety of Losartan in Children With Ig A Nephropathy

A Prospective Study Evaluating the Efficacy and Safety of Losartan in Children With Immunoglobulin A Nephropathy

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02232776
Enrollment
37
Registered
2014-09-05
Start date
2014-10-31
Completion date
2017-04-30
Last updated
2018-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glomerulonephritis, IGA

Keywords

Losartan, Ig A nephropathy, children, proteinuria

Brief summary

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

Detailed description

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.

Interventions

DRUGLosartan

Dose of Losartan : 0.7mg/kg once daily.

Sponsors

Ministry of Food and Drug Safety, Korea
CollaboratorOTHER_GOV
Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
24 Months to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the change in urinary protein-creatinine ratio from baseline to the end of study24weeksChange in urinary protein excretion, determined as urinary protein-creatinine ratio compared to baseline, after 24 weeks of treatment.

Secondary

MeasureTime frameDescription
the change in urinary albumin-creatinine ratio from baseline to the end of study24 weeksChange in urinary albumin-creatinine ratio compared to baseline, after 24 weeks of treatment.
the proportion of patients wifh more than 50% decrease of urinary protein-creatinine ratio24 weeksNumber of patients with wifh more than 50% decrease of urinary protein-creatinine ratio compared to baseline, after 24 weeks of treatment.
the proportion of patients wifh urinary protein-creatinine ratio < 0.2 at the end of study24 weeksNumber of patients wifh urinary protein-creatinine ratio \< 0.2 after 24 weeks of treatment.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026