Role of Montelukast in Preventing Relapse in Childhood Idiopathic Nephrotic Syndrome

Nishtar Medical University

Status: Completed

Conditions: Nephrotic Syndrome

Treatments: Drug: Montelukast

Study type: Interventional

Funder types: Other

Identifiers

NCT04818723

NishtarMU

Details and patient eligibility

About

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)

Full 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).

Enrollment: 106 patients

Sex: All

Ages: 1 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups, including a placebo group

Montelukast Group

Experimental group

Description:

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.

Treatment:

Drug: Montelukast

Placebo Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Montelukast