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| Name | Class |
|---|---|
| Ministry of Food and Drug Safety, Korea | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Losartan | Experimental | 12 weeks of losartan or placebo with crossover to the other |
|
| Placebo | Experimental | 12 weeks of losartan or placebo with crossover to the other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Losartan | Drug | 12 weeks of losartan or placebo with crossover to the other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hee Gyung Kang, Ph.D | Seoul National University Children's Hospital Departments of Pediatrics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Children's Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D019808 | Losartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Placebo | Drug | 12 weeks of losartan or placebo with crossover to the other |
|
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 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |