NCT02232763

Efficacy and Safety of Losartan in Pediatric Chronic Kidney Disease With Tubular Proteinuria

A Prospective, Randomized, Cross-over Study Evaluating the Efficacy and Safety of Losartan in Pediatric Chronic Kidney Disease With Tubular Proteinuria

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 24 Months – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Proteinuria

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-07-01
• Completion: 2016-09-01
• First posted: 2014-09-05
• Last updated: 2018-10-10

Locations

1 site across 1 country: South Korea