Back to resultsEfficacy and Safety of Losartan in Pediatric Chronic Kidney Disease With Tubular Proteinuria
Primary Purpose
Proteinuria
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Losartan
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Proteinuria focused on measuring Losartan, children, proteinuria
Eligibility Criteria
Inclusion Criteria:
- Age: 2years or older and younger than 18 years
- estimated GFR ≥ 30mL/min/m^2
- Mean urinary protein-creatinine ratio > 0.3 g/g from three first-morning spot urine collections
- Renal hypoplasia/dysplasia, Reflux nephropathy, Polycystic kidney disease, Lowe syndrome, Dent disease, Tubulointerstitial nephritis, Nephronophthisis/Medullary cystic disease, Obstructive uropathy(including PUV, UPJ obstruction, UVJ obstruction)
Exclusion Criteria:
- hypertension
- under dialysis or organ transplanted
- bilateral renal artery stenosis or primary hyperaldosteronism
- pregnant or nursing
Sites / Locations
- Seoul National University Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Losartan
Placebo
Arm Description
12 weeks of losartan or placebo with crossover to the other
12 weeks of losartan or placebo with crossover to the other
Outcomes
Primary Outcome Measures
the change in urinary protein-creatinine ratio from baseline to the end of 12 weeks
Change in urinary protein excretion, determined as urinary Protein-creatinine ratio compared to baseline, after 12 weeks of treatment
Secondary Outcome Measures
the change in urinary albumin-creatinine ratio from baseline to the end of study
Change in urinary albumin excretion, determined as urinary albumin-creatinine ratio compared to baseline, after 12 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 12 weeks of treatment
the change in urinary beta2-microglobulin-creatinine ratio from baseline to the end of study
Change in urinary beta2-microglobulin--creatinine ratio compared to baseline, after 12 weeks of treatment
the change in urinary NAG-creatinine ratio from baseline to the end of study
Change in urinary NAG-creatinine ratio compared to baseline, after 12 weeks of treatment
Full Information
NCT ID
NCT02232763
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
NCT02232763
Brief Title
Efficacy and Safety of Losartan in Pediatric Chronic Kidney Disease With Tubular Proteinuria
Official Title
A Prospective, Randomized, Cross-over Study Evaluating the Efficacy and Safety of Losartan in Pediatric Chronic Kidney Disease With Tubular Proteinuria
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
September 2016 (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 pediatric chronic kidney disease with tubular proteinuria.
Detailed Description
Children with tubular proteinuria (urine protein to creatinine ratio > 0.3 mg/mg) were randomly assigned in 1:1 ratio to losartan or placebo treatment for 12 weeks, then crossed over to the opposite intervention for another three months after a washout period of 2 weeks. The primary outcome is the change in urinary protein-creatinine ratio from baseline to the end of 12 weeks. Efficacy of losartan in children with CKD with tubular proteinuria was also investigated with additional retrospective review of medical record.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proteinuria
Keywords
Losartan, children, proteinuria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Losartan
Arm Type
Experimental
Arm Description
12 weeks of losartan or placebo with crossover to the other
Arm Title
Placebo
Arm Type
Experimental
Arm Description
12 weeks of losartan or placebo with crossover to the other
Intervention Type
Drug
Intervention Name(s)
Losartan
Other Intervention Name(s)
Cozaar
Intervention Description
12 weeks of losartan or placebo with crossover to the other
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
12 weeks of losartan or placebo with crossover to the other
Primary Outcome Measure Information:
Title
the change in urinary protein-creatinine ratio from baseline to the end of 12 weeks
Description
Change in urinary protein excretion, determined as urinary Protein-creatinine ratio compared to baseline, after 12 weeks of treatment
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
the change in urinary albumin-creatinine ratio from baseline to the end of study
Description
Change in urinary albumin excretion, determined as urinary albumin-creatinine ratio compared to baseline, after 12 weeks of treatment
Time Frame
12 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 12 weeks of treatment
Time Frame
12 weeks
Title
the change in urinary beta2-microglobulin-creatinine ratio from baseline to the end of study
Description
Change in urinary beta2-microglobulin--creatinine ratio compared to baseline, after 12 weeks of treatment
Time Frame
12 weeks
Title
the change in urinary NAG-creatinine ratio from baseline to the end of study
Description
Change in urinary NAG-creatinine ratio compared to baseline, after 12 weeks of treatment
Time Frame
12 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
estimated GFR ≥ 30mL/min/m^2
Mean urinary protein-creatinine ratio > 0.3 g/g from three first-morning spot urine collections
Renal hypoplasia/dysplasia, Reflux nephropathy, Polycystic kidney disease, Lowe syndrome, Dent disease, Tubulointerstitial nephritis, Nephronophthisis/Medullary cystic disease, Obstructive uropathy(including PUV, UPJ obstruction, UVJ obstruction)
Exclusion Criteria:
hypertension
under dialysis or organ transplanted
bilateral renal artery stenosis or primary hyperaldosteronism
pregnant or nursing
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 Pediatric Chronic Kidney Disease With Tubular Proteinuria
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