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OpenTrials
Completed

NCT Number: NCT04818723

Role of Montelukast in Preventing Relapse in Childhood Idiopathic Nephrotic Syndrome

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)

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Key information

Conditions

Nephrotic Syndrome Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrosis Urogenital Diseases Urologic Diseases

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pediatric Nephrology, The Children's Hospital and Institute of Child Health

Multan, PPunjab, Pakistan

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Montelukast

Drug

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

Primary outcomes

  1. Prevention of relapse in idiopathic childhood nephrotic syndrome

    Time frame: 1 year

    Relapse was labeled as recurrence of proteinuria 3+ or more for 3 consecutive days with or without edema

Sponsors and collaborators

Lead sponsor

Nishtar Medical University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 26, 2021
Registry last updated
Mar 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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