Back to resultsEfficacy and Safety of Losartan in Children With Ig A Nephropathy
Primary Purpose
Glomerulonephritis, IGA
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Losartan
Sponsored by
About this trial
This is an interventional treatment trial for Glomerulonephritis, IGA focused on measuring Losartan, Ig A nephropathy, children, proteinuria
Eligibility Criteria
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
Sites / Locations
- Seoul National University Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Losartan treatement
Arm Description
All patients had received losartan treatment for 24 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT02232776
First Posted
September 3, 2014
Last Updated
October 8, 2018
Sponsor
Seoul National University Hospital
Collaborators
Ministry of Food and Drug Safety, Korea
1. Study Identification
Unique Protocol Identification Number
NCT02232776
Brief Title
Efficacy and Safety of Losartan in Children With Ig A Nephropathy
Official Title
A Prospective Study Evaluating the Efficacy and Safety of Losartan in Children With Immunoglobulin A Nephropathy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
Collaborators
Ministry of Food and Drug Safety, Korea
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glomerulonephritis, IGA
Keywords
Losartan, Ig A nephropathy, children, proteinuria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Losartan treatement
Arm Type
Experimental
Arm Description
All patients had received losartan treatment for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Losartan
Other Intervention Name(s)
Cozaar
Intervention Description
Dose of Losartan : 0.7mg/kg once daily.
Primary Outcome Measure Information:
Title
the change in urinary protein-creatinine ratio from baseline to the end of study
Description
Change in urinary protein excretion, determined as urinary protein-creatinine ratio compared to baseline, after 24 weeks of treatment.
Time Frame
24weeks
Secondary Outcome Measure Information:
Title
the change in urinary albumin-creatinine ratio from baseline to the end of study
Description
Change in urinary albumin-creatinine ratio compared to baseline, after 24 weeks of treatment.
Time Frame
24 weeks
Title
the proportion of patients wifh more than 50% decrease of urinary protein-creatinine ratio
Description
Number of patients with wifh more than 50% decrease of urinary protein-creatinine ratio compared to baseline, after 24 weeks of treatment.
Time Frame
24 weeks
Title
the proportion of patients wifh urinary protein-creatinine ratio < 0.2 at the end of study
Description
Number of patients wifh urinary protein-creatinine ratio < 0.2 after 24 weeks of treatment.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee Gyung Kang, Ph.D
Organizational Affiliation
Seoul National University Children's Hospital Departments of Pediatrics
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Children's Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Losartan in Children With Ig A Nephropathy
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