Role of Montelukast in Preventing Relapse in Childhood Idiopathic Nephrotic Syndrome

NCT04818723 | Completed

• 1 other identifier: NishtarMU
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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)

Conditions

Nephrotic Syndrome

Keywords

Leukotriene antagonists; Nephrotic syndrome; Steroid

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Montelukast Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Montelukast DRUG

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

Montelukast Group; Placebo Group

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Nishtar Medical University: lead

Study Sites (1)

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

Multan, PPunjab, Pakistan

Location

MeSH Terms

Conditions

Nephrotic Syndrome

Interventions

montelukast

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 26, 2021
• Study Start: February 1, 2019
• Primary Completion: May 30, 2020
• Study Completion: May 30, 2020
• Last Updated: March 26, 2021

Record last verified: 2021-03

Locations

PA (1)