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

October 8, 2018 updated by: Seoul National University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Losartan
12 weeks of losartan or placebo with crossover to the other
Drug: Losartan
12 weeks of losartan or placebo with crossover to the other
Other Names:
  • Cozaar
Experimental: Placebo
12 weeks of losartan or placebo with crossover to the other
Drug: Placebo
12 weeks of losartan or placebo with crossover to the other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change in urinary protein-creatinine ratio from baseline to the end of 12 weeks
Time Frame: 12 weeks
Change in urinary protein excretion, determined as urinary Protein-creatinine ratio compared to baseline, after 12 weeks of treatment
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change in urinary albumin-creatinine ratio from baseline to the end of study
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
Change in urinary NAG-creatinine ratio compared to baseline, after 12 weeks of treatment
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Ministry of Food and Drug Safety, Korea

Investigators

  • Study Chair: Hee Gyung Kang, Ph.D, Seoul National University Children's Hospital Departments of Pediatrics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

September 3, 2014

First Submitted That Met QC Criteria

September 3, 2014

First Posted (Estimate)

September 5, 2014

Study Record Updates

Last Update Posted (Actual)

October 10, 2018

Last Update Submitted That Met QC Criteria

October 8, 2018

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Losartan_tubularPU_2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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