Efficacy and Safety of Losartan in Children With Ig A Nephropathy

Glomerulonephritis, IGA Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02232776
• Other study ID #: Losartan_IgA_2014
• Status: Completed
• Phase: Phase 3
• Start date: October 2014
• Est. completion date: April 2017

Study information

• Verified date: July 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: April 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Glomerulonephritis
• Glomerulonephritis, IGA
• Kidney Diseases

Intervention

Drug:
• Losartan
Dose of Losartan : 0.7mg/kg once daily.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Children's Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Ministry of Food and Drug Safety, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the change in urinary albumin-creatinine ratio from baseline to the end of study	Change in urinary albumin-creatinine ratio compared to baseline, after 24 weeks of treatment.	24 weeks
Secondary	the proportion of patients wifh more than 50% decrease of urinary protein-creatinine ratio	Number of patients with wifh more than 50% decrease of urinary protein-creatinine ratio compared to baseline, after 24 weeks of treatment.	24 weeks
Secondary	the proportion of patients wifh urinary protein-creatinine ratio < 0.2 at the end of study	Number of patients wifh urinary protein-creatinine ratio < 0.2 after 24 weeks of treatment.	24 weeks