Evidence map›Paper›PMID 38822220›Full record

Trial reportPediatric nephrology (Berlin, Germany)2024

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

Sushmita Banerjee, Jayati Sengupta, Rajiv Sinha, Suparna Chatterjee, Subhankar Sarkar, Shakil Akhtar, Rana Saha, Amitava Pahari

Abstract readRandomized Controlled TrialComparative Study
PubMed Publisher
In one paragraph

Trial report in Pediatric nephrology (Berlin, Germany), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Sushmita BanerjeeDepartment of Nephrology, Institute of Child Health, Kolkata, India. asban444@gmail.com.ORCID 0000-0003-0958-616X
Jayati SenguptaDepartment of Nephrology, Institute of Child Health, Kolkata, India.
Rajiv SinhaDepartment of Nephrology, Institute of Child Health, Kolkata, India.
Suparna ChatterjeeDepartment of Pharmacology, Institute of Post Graduate Medical Education & Research, Kolkata, India.
Subhankar SarkarDepartment of Nephrology, Institute of Child Health, Kolkata, India.
Shakil AkhtarDepartment of Nephrology, Institute of Child Health, Kolkata, India.
Rana SahaDepartment of Nephrology, Institute of Child Health, Kolkata, India.
Amitava PahariDepartment of Nephrology, Institute of Child Health, Kolkata, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLevamisole 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).

methodsAn 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.

resultsA 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.

conclusionsDaily 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.

Indexed as

LevamisoleNephrotic SyndromeRecurrenceAdolescentChildChild, PreschoolDrug Administration ScheduleFemaleGlucocorticoidsHumansMalePrednisoloneRemission InductionTreatment OutcomeGlucocorticoidsLevamisolePrednisoloneFrequently relapsingLevamisoleNephrotic syndromeNeutropeniaSteroid dependentTransaminitis

Identifiers

What Socratic holds

Textmetadata
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.