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NCT04818723 Clinical Trial

Role of Montelukast in Preventing Relapse in Childhood Idiopathic Nephrotic Syndrome

Nephrotic Syndrome Clinical Trial

Official title:
Role of Montelukast in Preventing Relapse in Childhood Idiopathic Nephrotic Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04818723
Other study ID # NishtarMU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2019
Est. completion date May 30, 2020

Study information
Verified date March 2021
Source Nishtar Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators planned this research to elucidate if there is any efficacy of montelukast, a leukotriene receptor antagonist, in steroid sensitive childhood onset NS to help prevent relapses. This study was done to know the role of leukotriene receptor antagonist (LTRA) montelukast in preventing relapses in idiopathic childhood nephrotic syndrome (NS)

Description:

A quasi-experimental study, done at Department of Pediatric Nephrology at the Children's Hospital & the Institute of Child Health, Multan. A total of 96 patients aged 1-10 years with steroid sensitive Idiopathic NS were assigned into two groups (48 patients in each group). The case group received montelukast 5mg daily at bed time while the control group was not given montelukast. Steroid treatment protocol was the same for the two groups as per institutional guidelines. Patients were monitored and followed for the response to treatment and evidence of relapse over the study period (minimum 12 months).

Recruitment information / eligibility
Status Completed
Enrollment 106
Est. completion date May 30, 2020
Est. primary completion date May 30, 2020
Accepts healthy volunteers No
Gender All
Age group 1 Year to 10 Years
Eligibility Inclusion Criteria:A total of 106 children aged 1-10 years with idiopathic nephrotic syndrome were enrolled - Exclusion Criteria: - Patients having Steroid resistant nephrotic syndrome (SRNS) or those having nephrotic syndrome with atypical features or Secondary cause were excluded.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Montelukast
We wanted to know the role of leukotriene receptor antagonist (LTRA) montelukast in preventing relapses in idiopathic childhood nephrotic syndrome (NS)

Locations
Country Name City State
Pakistan Department of Pediatric Nephrology, The Children's Hospital and Institute of Child Health Multan PPunjab

Sponsors (1)
Lead Sponsor Collaborator
Nishtar Medical University

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevention of relapse in idiopathic childhood nephrotic syndrome Relapse was labeled as recurrence of proteinuria 3+ or more for 3 consecutive days with or without edema 1 year
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