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

Proteinuria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02232763
• Other study ID #: Losartan_tubularPU_2014
• Status: Completed
• Phase: Phase 3
• Start date: September 2014
• Est. completion date: September 2016

Study information

• Verified date: July 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesize that using Losartan would help decrease proteinuria in pediatric chronic kidney disease with tubular proteinuria.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Proteinuria
• Renal Insufficiency, Chronic

Intervention

Drug:
• Losartan
12 weeks of losartan or placebo with crossover to the other
• Placebo
12 weeks of losartan or placebo with crossover to the other

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Children's Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Ministry of Food and Drug Safety, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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	12 weeks
Secondary	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
Secondary	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