Role of Montelukast in Preventing Relapse in Childhood Idiopathic Nephrotic Syndrome

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04818723

Enrollment

106

Registered

2021-03-26

Start date

2019-02-01

Completion date

2020-05-30

Last updated

2021-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephrotic Syndrome

Keywords

Leukotriene antagonists, Nephrotic syndrome, Steroid

Brief 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)

Detailed 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).

Interventions

DRUGMontelukast

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

During the study period, adopting non-probability consecutive sampling method, patients were assigned into two groups; 53 in Case Group (given montelukast 5mg at bed time) and 53 in Control Group (given no montelukast).

Eligibility

Sex/Gender

ALL

Age

1 Years to 10 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026