Evidence map›Paper›PMID 32232637›Full record

Trial reportPediatric nephrology (Berlin, Germany)2020

Rituximab for very low dose steroid-dependent nephrotic syndrome in children: a randomized controlled study.

Pietro Ravani, Francesca Lugani, Isabella Pisani, Monica Bodria, Giorgio Piaggio, Domenico Bartolomeo, Marco Prunotto, Gian Marco Ghiggeri

Abstract readRandomized Controlled TrialEquivalence Trial
PubMed Publisher
In one paragraph

Trial report in Pediatric nephrology (Berlin, Germany), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 3 pooled it
3.1field-weighted citation impact, top 8% of its field
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

23 citing papers in PubMed, 3 syntheses or guidelines pooled it, 35 citations in OpenAlex.

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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 at 4 institutions in 3 countries.

Pietro RavaniDivision of Nephrology, Faculty of Medicine, Foothills Medical Centre, University of Calgary, 1403-29th Street NW, Calgary, AB, T2N 2T9, Canada. pravani@ucalgary.ca.
Francesca LuganiDivision of Nephrology, Dialysis, Transplantation, Giannina Gaslini Children's Hospital, Via Gerolamo Gaslini 5, 16148, Genoa, Italy.
Isabella PisaniDepartment of Medicine and Surgery, Division of Nephrology, School of Nephrology, University of Parma, Parma, Italy.
Monica BodriaDivision of Nephrology, Dialysis, Transplantation, Giannina Gaslini Children's Hospital, Via Gerolamo Gaslini 5, 16148, Genoa, Italy.
Giorgio PiaggioDivision of Nephrology, Dialysis, Transplantation, Giannina Gaslini Children's Hospital, Via Gerolamo Gaslini 5, 16148, Genoa, Italy.
Domenico BartolomeoDepartment of Medicine and Surgery, Division of Nephrology, School of Nephrology, University of Parma, Parma, Italy.
Marco PrunottoSchool of Pharmaceutical Sciences, University of Geneva, Geneva, Switzerland.
Gian Marco GhiggeriDivision of Nephrology, Dialysis, Transplantation, Giannina Gaslini Children's Hospital, Via Gerolamo Gaslini 5, 16148, Genoa, Italy. GMarcoGhiggeri@ospedale-gaslini.ge.it.
Istituto Giannina Gaslini · ITUniversity of Parma · ITFoothills Medical Centre · CAUniversity of Geneva · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSteroid-dependent nephrotic syndrome (SDNS) carries a high risk of toxicity from steroids or steroid-sparing agents. This open-label, randomized controlled trial was designed to test whether the monoclonal antibody rituximab is non-inferior to steroids in maintaining remission in juvenile forms of SDNS and how long remission may last (EudraCT:2008-004486-26).

methodsWe enrolled 30 children 4-15 years who had developed SDNS 6-12 months before and were maintained in remission with low prednisone doses (0.1-0.4 mg/Kg/day). Participants were randomized following a non-inferiority design to continue prednisone alone (n 15, controls) or to add a single intravenous infusion of rituximab (375 mg/m

resultsProteinuria increased at 3 months in the prednisone group (from 0.14 to 1.5 g/day) (p < 0.001) and remained unchanged in the rituximab group (0.14 g/day). Fourteen children in the control arm relapsed within 6 months. Thirteen children assigned to rituximab (87%) were still in remission at 1 year and 8 (53%) at 4 years. Responses were similar in children of the control group who received rituximab to treat disease relapse. We did not record significant adverse events.

conclusionsRituximab was non-inferior to steroids for the treatment of juvenile SDNS. One in two children remains in remission at 4 years following a single infusion of rituximab, without significant adverse events. Further studies are needed to clarify the superiority of rituximab over low-dose corticosteroid as a treatment of SDNS.

Indexed as

Antibodies, MonoclonalChildChild, PreschoolFemaleGlucocorticoidsHumansMaleNephrotic SyndromePrednisoloneRemission InductionRituximabAntibodies, MonoclonalGlucocorticoidsPrednisoloneRituximabPaediatric nephrologyRituximabSteroid-dependent nephrotic syndrome

Identifiers

PMID32232637
OpenAlexW3013380967

What OpenQuestion holds

Textmetadata
Read underepoch 390

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 OpenQuestion graph.