Efficacy and Safety of Losartan in Children With Ig A Nephropathy

Phase 3

Completed

• Conditions: Glomerulonephritis, IGA
• Interventions: Drug: Losartan

• Registration Number: NCT02232776
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2014-09-03
• Study First Submitted QC: 2014-09-03
• Study First Posted: 2014-09-05
• Study Start: 2014-10
• Primary Completion: 2016-12
• Study Completion: 2017-04
• Status Verified: 2017-07
• Last Update Submitted: 2018-10-08
• Last Update Posted: 2018-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Losartan treatement	Losartan	All patients had received losartan treatment for 24 weeks.

Primary Outcome Measures

Name	Time	Method
the change in urinary protein-creatinine ratio from baseline to the end of study	24weeks	Change in urinary protein excretion, determined as urinary protein-creatinine ratio compared to baseline, after 24 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
the proportion of patients wifh urinary protein-creatinine ratio < 0.2 at the end of study	24 weeks	Number of patients wifh urinary protein-creatinine ratio \< 0.2 after 24 weeks of treatment.
the change in urinary albumin-creatinine ratio from baseline to the end of study	24 weeks	Change 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 ratio	24 weeks	Number of patients with wifh more than 50% decrease of urinary protein-creatinine ratio compared to baseline, after 24 weeks of treatment.

Trial Locations

Locations (1)

Seoul National University Children's Hospital; 🇰🇷 Seoul, Korea, Republic of