Role of Montelukast in Preventing Relapse in Childhood Idiopathic Nephrotic Syndrome

Not Applicable

Completed

• Conditions: Nephrotic Syndrome
• Interventions: Drug: Montelukast

• Registration Number: NCT04818723
• Lead Sponsor: Nishtar Medical University

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).

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2020-05-30
• Study Completion: 2020-05-30
• Status Verified: 2021-03
• Study First Submitted: 2021-03-22
• Study First Submitted QC: 2021-03-23
• Last Update Submitted: 2021-03-23
• Study First Posted: 2021-03-26
• Last Update Posted: 2021-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Montelukast	Patients in this groups were induced with prednisolone 2mg/kg single morning dose with breakfast for total 4 weeks. Patients who did not achieve remission after 4 weeks' full dose were labeled steroid resistant nephrotic syndrome (SRNS). Children with steroid sensitive nephrotic syndrome SSNS were further treated by prednisolone 1.5 mg/kg single morning dose with breakfast every other day for the next 4 weeks. Prednisolone was then tapered by reducing 25% dose fortnightly and completely stopped in 8 weeks. Patients in the Case Group continued taking montelukast after stopping steroids. All patients were followed up every 4-8 weeks for a minimum of 12 months to look for response to treatment, side effects of medications, other co-morbidities, and the number of relapses. Relapses were treated with repeat prednisolone doses according to the protocol of treatment for relapse.
Montelukast Group	Montelukast	53 in Case Group (given montelukast 5mg at bed time). All patients were induced with prednisolone 2mg/kg single morning dose with breakfast for total 4 weeks. Patients who did not achieve remission after 4 weeks' full dose were labeled steroid resistant nephrotic syndrome (SRNS). Children with steroid sensitive nephrotic syndrome SSNS were further treated by prednisolone 1.5 mg/kg single morning dose with breakfast every other day for the next 4 weeks. Prednisolone was then tapered by reducing 25% dose fortnightly and completely stopped in 8 weeks. Patients in the Case Group continued taking montelukast after stopping steroids. All patients were followed up every 4-8 weeks for a minimum of 12 months to look for response to treatment, side effects of medications, other co-morbidities, and the number of relapses. Relapses were treated with repeat prednisolone doses according to the protocol of treatment for relapse.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Pediatric Nephrology, The Children's Hospital and Institute of Child Health; 🇵🇰 Multan, PPunjab, Pakistan