Evidence map›Paper›PMID 21566104›Full record

Trial reportClinical journal of the American Society of Nephrology : CJASN2011

Short-term effects of rituximab in children with steroid- and calcineurin-dependent nephrotic syndrome: a randomized controlled trial.

Pietro Ravani, Alberto Magnasco, Alberto Edefonti, Luisa Murer, Rossella Rossi, Luciana Ghio, Elisa Benetti, Floriana Scozzola, Andrea Pasini, Nadia Dallera and 4 more

4 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical journal of the American Society of Nephrology : CJASN, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 120 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
120citing papers in PubMed, 11 pooled it
8.0field-weighted citation impact, top 2% 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.

NCT02394106 phase2terminatednot on this mapstarted 2015, after this paper: background citation

Ofatumumab in Children With Steroid- and Calcineurin-inhibitor-resistant Nephrotic Syndrome: a Double-blind Randomized, Controlled, Superiority Trial

TypeinterventionalSponsorIstituto Giannina GasliniRan2015 to 2019Enrolled13ConditionsNephrotic SyndromeArmsOfatumumab, Placebo
NCT02394119 phase2completednot on this mapstarted 2015, after this paper: background citation

Ofatumumab Versus Rituximab in Children With Steroid and Calcineurin Inhibitor-dependent Idiopathic Nephrotic Syndrome: an Open-label, Randomized, Controlled, Superiority Trial.

TypeinterventionalSponsorIstituto Giannina GasliniRan2015 to 2019Enrolled140ConditionsNephrotic SyndromeArmsOfatumumab, Rituximab
NCT02455908 phase1 / phase2completednot on this mapstarted 2012, after this paper: background citation

Use of IL-2 for Pediatric, Multi Drug Resistant, Idiopathic Nephrotic Syndrome

TypeinterventionalSponsorIstituto Giannina GasliniRan2012 to 2012Enrolled5ConditionsNephrotic SyndromeArmsProleukin®
NCT04494438 phase3completednot on this mapstarted 2013, after this paper: background citation

Rituximab in Patients With Low Dose Steroid-dependent Idiopathic Nephrotic Syndrome

TypeinterventionalSponsorIstituto Giannina GasliniRan2013 to 2016Enrolled30ConditionsIdiopathic Nephrotic SyndromeArmsRituximab
3 · Its place in the literature

Who cites it

120 citing papers in PubMed, 11 syntheses or guidelines pooled it, 213 citations in OpenAlex.

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  12. Steroid-sparing drugs in children and young adults with nephrotic syndrome: a target trial emulation.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2026
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60 more citing papers are in PubMed but not listed here.

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

14 authors at 7 institutions in 2 countries.

Pietro RavaniDivision of Nephrology, University of Calgary, Calgary, Alberta, Canada.
Alberto Magnasco
Alberto Edefonti
Luisa Murer
Rossella Rossi
Luciana Ghio
Elisa Benetti
Floriana Scozzola
Andrea Pasini
Nadia Dallera
Felice Sica
Mirco Belingheri
Francesco Scolari
Gian Marco Ghiggeri
University of Padua · ITFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITIstituto Giannina Gaslini · ITUniversity of Calgary · CAUniversity of Bologna · ITUniversity of Foggia · ITUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesPrednisone and calcineurin inhibitors are the mainstay therapy of idiopathic nephrotic syndrome (INS) in children. However, drug dependence and toxicity associated with protracted use are common. Case series suggest that the anti-CD20 monoclonal antibody rituximab (RTX) may maintain disease remission. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: This open-label randomized controlled trial was powered to show that a strategy based on RTX and lower doses of prednisone and calcineurin inhibitors was noninferior to standard doses of these agents in maintaining 3-month proteinuria as low as baseline or up to 1 g/d greater (noninferiority margin). Participants were stratified by the presence of toxicity to prednisone/calcineurin inhibitors and centrally assigned to add RTX (Mabthera, 375 mg/m(2) intravenously) to lower doses of standard agents or to continue with current therapy alone. The risk of relapse was a secondary outcome.

resultsFifty-four children (mean age 11 ± 4 years) with INS dependent on prednisone and calcineurin inhibitors for >12 months were randomized. Three-month proteinuria was 70% lower in the RTX arm (95% confidence interval 35% to 86%) as compared with standard therapy arm (intention-to-treat); relapse rates were 18.5% (intervention) and 48.1% (standard arm) (P = 0.029). Probabilities of being drug-free at 3 months were 62.9% and 3.7%, respectively (P < 0.001); 50% of RTX cases were in stable remission without drugs after 9 months.

conclusionsRituximab and lower doses of prednisone and calcineurin inhibitors are noninferior to standard therapy in maintaining short-term remission in children with INS dependent on both drugs and allow their temporary withdrawal.

Indexed as

Calcineurin InhibitorsAdolescentAntibodies, Monoclonal, Murine-DerivedCalcineurinChildDrug Administration ScheduleDrug Therapy, CombinationEnzyme InhibitorsFemaleHumansImmunosuppressive AgentsItalyKaplan-Meier EstimateLogistic ModelsMaleNephrotic SyndromeAntibodies, Monoclonal, Murine-DerivedCalcineurinCalcineurin InhibitorsEnzyme InhibitorsImmunosuppressive AgentsRituximabSteroids

Identifiers

PMID21566104
PMCPMC3109926
OpenAlexW2106387428

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.