Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2024 Oct;39(10):2969-2977.
doi: 10.1007/s00467-024-06402-9. Epub 2024 Jun 1.

Daily compared with alternate-day levamisole in pediatric nephrotic syndrome: an open-label randomized controlled study

Sushmita Banerjee  1 , Jayati Sengupta  2 , Rajiv Sinha  2 , Suparna Chatterjee  3 , Subhankar Sarkar  2 , Shakil Akhtar  2 , Rana Saha  2 , Amitava Pahari  2
Affiliations
Randomized Controlled Trial

Daily compared with alternate-day levamisole in pediatric nephrotic syndrome: an open-label randomized controlled study

Sushmita Banerjee et al. Pediatr Nephrol. 2024 Oct.

Abstract

Background: Levamisole is less expensive and has a better toxicity profile compared to other steroid sparing agents used in nephrotic syndrome. It has a plasma half-life of 2.0 to 5.6 hours, but is conventionally administered on alternate days. We aimed to assess whether daily levamisole is safe and more effective than standard alternate-day therapy in maintaining remission in children with frequently relapsing or steroid-dependent nephrotic syndrome (FR/SDNS).

Methods: An open-label randomized controlled trial was conducted in children with FR/SDNS. Group A received daily while Group B received alternate-day levamisole (2-3 mg/kg/dose) for 12 months. Prednisolone was tapered off by 3 months. Patients were monitored for relapses, further steroid requirement, and adverse effects.

Results: A total of 190 children with FR/SDNS (94 in Group A and 96 in Group B) were analyzed. Sustained remission for 12 months was observed in 36% of Group A and 27% of Group B patients (p = 0.18). Numbers completing 12 months in the study were 67% in Group A and 56% in Group B (p = 0.13). Time to first relapse, persistent FR/SDNS, and withdrawal due to poor compliance were statistically similar in both groups, while relapse rate and cumulative steroid dosage were significantly lower in Group A compared to Group B (p = 0.03 and p = 0.02, respectively). The incidence of adverse effects was comparable in both groups, with reversible leucopenia and hepatic transaminitis being the commonest.

Conclusions: Daily levamisole therapy was not superior to alternate-day therapy in maintaining sustained remission over 12 months. Nevertheless, relapse rate and cumulative steroid dosage were significantly lower without increased adverse effects.

Keywords: Frequently relapsing; Levamisole; Nephrotic syndrome; Neutropenia; Steroid dependent; Transaminitis.

PubMed Disclaimer

References

    1. Sinha A, Bagga A, Banerjee S et al (2021) Steroid sensitive nephrotic syndrome: revised guidelines. Indian Pediatr 58:461–481. https://doi.org/10.1007/s13312-021-2217-3 - DOI - PubMed - PMC
    1. Trautmann A, Boyer O, Hodson E et al (2023) IPNA clinical practice recommendations for the diagnosis and management of children with steroid-sensitive nephrotic syndrome. Pediatr Nephrol 38:877–919. https://doi.org/10.1007/s00467-022-05739-3 - DOI - PubMed
    1. Bhatt GC, Patel B, Das RR, Malik S, Bitzan M, Mishra NR (2023) Efficacy and safety of levamisole in childhood nephrotic syndrome: a meta-analysis. Indian J Pharmacol 55:43–52. https://doi.org/10.4103/ijp.ijp_673_21 - DOI - PubMed - PMC
    1. Larkins NG, Liu ID, Willis NS, Craig JC, Hodson EM (2020) Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children. Cochrane Database Syst Rev 4(4):CD002290. https://doi.org/10.1002/14651858.CD002290.pub5 - DOI - PubMed
    1. Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group. KDIGO (2021) (2021) clinical practice guideline for the management of glomerular diseases. Kidney Int 100:S1–S276. https://doi.org/10.1016/j.kint.2021.05.021 - DOI

Publication types

LinkOut - more resources