Role of Montelukast in Preventing Relapse in Childhood Idiopathic Nephrotic Syndrome

Study Overview
=================
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).

Official Title
-----------------
Role of Montelukast in Preventing Relapse in Childhood Idiopathic Nephrotic Syndrome

Conditions
-----------------
Nephrotic Syndrome

Intervention / Treatment
-----------------
* Drug: Montelukast


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Montelukast Group<br>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. | Drug: Montelukast<br>* We wanted to know the role of leukotriene receptor antagonist (LTRA) montelukast in preventing relapses in idiopathic childhood nephrotic syndrome (NS)<br>|
| Placebo Comparator: Placebo Group<br>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. | Drug: Montelukast<br>* We wanted to know the role of leukotriene receptor antagonist (LTRA) montelukast in preventing relapses in idiopathic childhood nephrotic syndrome (NS)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Leukotriene antagonists, Nephrotic syndrome, Steroid