Montelukast as a Renal Protective Adjunct in Childhood Steroid-sensitive Nephrotic Syndrome: A Quasi-experimental Study
Journal of Pediatric Nephrology,
Vol. 12 No. 1 (2024),
10 April 2025,
https://doi.org/10.22037/jpn.v12i1.48977
Background and Aim: Nephrotic syndrome (NS) is the most common glomerular disease
in children in Iran, with high relapse rates and steroid-related complications. Montelukast, a
leukotriene receptor antagonist, has shown potential as a steroid-sparing agent, but its renal
protective effects remain debated. This study aimed to compare the efficacy of prednisolone
monotherapy versus combined prednisolone-montelukast therapy in pediatric NS, focusing
on renal function, metabolic parameters, and safety.
Methods: A quasi-experimental study involving 66 children with NS was conducted at
Ali Bin Abi Taleb Hospital, Iran (2022). Participants were divided into two groups: Group
A (prednisolone+montelukast, n=33) and group B (prednisolone alone, n=33). Primary
outcomes included time to remission and 6-month relapse rates. Secondary outcomes were
serum albumin, urine protein-to-creatinine ratio (Upro/Cr), estimated glomerular filtration
rate, and adverse events.
Results: Both groups showed significant improvements in albumin, cholesterol, and
proteinuria (P<0.001). However, group A demonstrated superior renal protection, with a
significant reduction in serum creatinine (−0.08 mg/dL vs +0.11 mg/dL in group B, P=0.001).
Subgroup analysis revealed enhanced creatinine improvement in children <6 years (P=0.02).
No serious adverse events were reported, and safety profiles were comparable (gastrointestinal
symptoms: 12.1% vs 9.1%, P=0.7).
Conclusion: Adjunctive montelukast provides additional renal protection, particularly in
younger children, without compromising metabolic efficacy or safety. These findings support
its consideration in high-risk pediatric patients with NS, warranting further long-term studies.