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

NCT ID: NCT02232763

Last Updated: 2018-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-09-30

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.

Conditions

Proteinuria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Losartan

12 weeks of losartan or placebo with crossover to the other

Group Type: EXPERIMENTAL

Losartan

Intervention Type: DRUG

12 weeks of losartan or placebo with crossover to the other

Placebo

12 weeks of losartan or placebo with crossover to the other

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

12 weeks of losartan or placebo with crossover to the other

Interventions

Losartan

12 weeks of losartan or placebo with crossover to the other

Intervention Type: DRUG

Placebo

12 weeks of losartan or placebo with crossover to the other

Intervention Type: DRUG

Other Intervention Names

Cozaar

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

• Minimum Eligible Age: 24 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Food and Drug Safety, Korea

OTHER_GOV

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hee Gyung Kang, Ph.D

Role: STUDY_CHAIR

Seoul National University Children's Hospital Departments of Pediatrics

Locations

Seoul National University Children's Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

Losartan_tubularPU_2014

Identifier Type: -

Identifier Source: org_study_id