A Phase 3 interventional study of Losartan and Placebo in Proteinuria, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 24 Months to 18 Years. Per ClinicalTrials.gov, last updated 2018-10-10.
Sponsored by Seoul National University Hospital · Phase 3, Interventional, and Treatment
The investigators hypothesize that using Losartan would help decrease proteinuria in pediatric chronic kidney disease with tubular proteinuria.
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 58 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
12 weeks of losartan or placebo with crossover to the other
Drug: Losartan
12 weeks of losartan or placebo with crossover to the other
Drug: Placebo
12 weeks of losartan or placebo with crossover to the other
Also known as: Cozaar
12 weeks of losartan or placebo with crossover to the other
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
Time frame: 12 weeks
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 weeks
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital