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Efficacy and Safety of Losartan in Children With Ig A Nephropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02232776
Recruitment Status : Completed
First Posted : September 5, 2014
Last Update Posted : October 10, 2018
Sponsor:
Collaborator:
Ministry of Food and Drug Safety, Korea
Information provided by (Responsible Party):
Seoul National University Hospital

Brief Summary:
The investigators hypothesize that using Losartan would help decrease proteinuria in controlling proteinuria in children with immunoglobulin A nephropathy.

Condition or disease Intervention/treatment Phase
Glomerulonephritis, IGA Drug: Losartan Phase 3

Detailed Description:
Twenty nine patient with IgA nephropathy with proteinuria (urine protein to creatinine ratio > 0.3 mg/mg) were included in the study. All patients had received losartan treatment for 24 weeks. Changes in blood pressure, proteinuria, renal function, and biochemical parameters were prospectively evaluated before and at 4 weeks and 24 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study Evaluating the Efficacy and Safety of Losartan in Children With Immunoglobulin A Nephropathy
Study Start Date : October 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Losartan treatement
All patients had received losartan treatment for 24 weeks.
Drug: Losartan
Dose of Losartan : 0.7mg/kg once daily.
Other Name: Cozaar




Primary Outcome Measures :
  1. the change in urinary protein-creatinine ratio from baseline to the end of study [ Time Frame: 24weeks ]
    Change in urinary protein excretion, determined as urinary protein-creatinine ratio compared to baseline, after 24 weeks of treatment.


Secondary Outcome Measures :
  1. the change in urinary albumin-creatinine ratio from baseline to the end of study [ Time Frame: 24 weeks ]
    Change in urinary albumin-creatinine ratio compared to baseline, after 24 weeks of treatment.

  2. the proportion of patients wifh more than 50% decrease of urinary protein-creatinine ratio [ Time Frame: 24 weeks ]
    Number of patients with wifh more than 50% decrease of urinary protein-creatinine ratio compared to baseline, after 24 weeks of treatment.

  3. the proportion of patients wifh urinary protein-creatinine ratio < 0.2 at the end of study [ Time Frame: 24 weeks ]
    Number of patients wifh urinary protein-creatinine ratio < 0.2 after 24 weeks of treatment.



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Ages Eligible for Study:   24 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 2years or older and younger than 18 years
  • Biopsy-proven Ig A Nephropathy
  • Estimated GFR ≥ 90mL/min/m^2
  • Mean urinary protein-creatinine ratio > 0.3 g/g from three first-morning spot urine collections

Exclusion Criteria:

  • hypertension
  • under dialysis or organ transplanted
  • bilateral renal artery stenosis
  • primary hyperaldosteronism
  • pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02232776


Locations
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Korea, Republic of
Seoul National University Children's Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Ministry of Food and Drug Safety, Korea
Investigators
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Study Chair: Hee Gyung Kang, Ph.D Seoul National University Children's Hospital Departments of Pediatrics
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02232776    
Other Study ID Numbers: Losartan_IgA_2014
First Posted: September 5, 2014    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: July 2017
Keywords provided by Seoul National University Hospital:
Losartan
Ig A nephropathy
children
proteinuria
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis
Glomerulonephritis, IGA
Urologic Diseases
Nephritis
Autoimmune Diseases
Immune System Diseases
Losartan
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action