Logo 1 Logo 2

Clinical Trial Details

Trial ID: L1493
Source ID: NCT02232763
Associated Drug: Losartan
Title: Efficacy and Safety of Losartan in Pediatric Chronic Kidney Disease With Tubular Proteinuria
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Proteinuria
Interventions: DRUG: Losartan|DRUG: Placebo
Outcome Measures: Primary: 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, 12 weeks | Secondary: 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, 12 weeks|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, 12 weeks|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, 12 weeks|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, 12 weeks
Sponsor/Collaborators: Sponsor: Seoul National University Hospital | Collaborators: Ministry of Food and Drug Safety, Korea
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE3
Enrollment: 58
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2014-09
Completion Date: 2016-09
Results First Posted:
Last Update Posted: 2018-10-10
Locations: Seoul National University Children's Hospital, Seoul, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT02232763