Status:
COMPLETED
Efficacy and Safety of Losartan in Pediatric Chronic Kidney Disease With Tubular Proteinuria
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Ministry of Food and Drug Safety, Korea
Conditions:
Proteinuria
Eligibility:
All Genders
24-18 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- hypertension
- under dialysis or organ transplanted
- bilateral renal artery stenosis or primary hyperaldosteronism
- pregnant or nursing
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT02232763
Start Date
September 1 2014
End Date
September 1 2016
Last Update
October 10 2018
Active Locations (1)
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1
Seoul National University Children's Hospital
Seoul, South Korea