Evidence map›Paper›PMID 25592855›Full record

Trial reportJournal of the American Society of Nephrology : JASN2015

Rituximab in Children with Steroid-Dependent Nephrotic Syndrome: A Multicenter, Open-Label, Noninferiority, Randomized Controlled Trial.

Pietro Ravani, Roberta Rossi, Alice Bonanni, Robert R Quinn, Felice Sica, Monica Bodria, Andrea Pasini, Giovanni Montini, Alberto Edefonti, Mirco Belingheri and 8 more

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

Trial report in Journal of the American Society of Nephrology : JASN, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 129 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
129citing papers in PubMed, 9 pooled it
13.3field-weighted citation impact, top 1% 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 map

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 map

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
NCT06890143 phase3recruitingnot on this mapstarted 2025, after this paper: background citation

The Efficacy and Safety of Dapagliflozin in the Treatment of Hereditary Kidney Disease With Proteinuria in Children: a Prospective, Randomized Crossover Trial

TypeinterventionalSponsorChildren's Hospital of Fudan UniversityRan2025 to 2027Enrolled44ConditionsPediatric Hereditary Kidney DiseasesArmsDapagliflozin+Standard Treatment for 12 weeks,washout period for 4 weeks,then Standard Treatment alone for12 weeks, Standard Treatment alone for 12 weeks ,washout period for 4 weeks ,then Dapagliflozin+Standard Treatment for 12 weeks
3 · Its place in the literature

Who cites it

129 citing papers in PubMed, 9 syntheses or guidelines pooled it, 198 citations in OpenAlex.

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  10. 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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  14. Vaccines and Disease Relapses in Children with Nephrotic Syndrome.Clinical journal of the American Society of Nephrology : CJASN · 2021
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69 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 10 institutions in 4 countries.

Pietro RavaniDivision of Nephrology, University of Calgary, Calgary, Alberta, Canada; GMarcoGhiggeri@ospedale-gaslini.ge.it pravani@ucalgary.ca.
Roberta RossiDivision of Nephrology, Dialysis, Transplantation, Giannina Gaslini Children's Hospital, Genoa, Italy;
Alice BonanniDivision of Nephrology, Dialysis, Transplantation, Giannina Gaslini Children's Hospital, Genoa, Italy;
Robert R QuinnDivision of Nephrology, University of Calgary, Calgary, Alberta, Canada;
Felice SicaDivision of Pediatrics, Hospital of Foggia, Foggia, Italy;
Monica BodriaDivision of Nephrology, Dialysis, Transplantation, Giannina Gaslini Children's Hospital, Genoa, Italy;
Andrea PasiniNephrology and Pediatric Dialysis, Department of Pediatrics, Azienda Ospedaliera Universitaria Sant'Orsola, Bologna, Italy;
Giovanni MontiniNephrology and Pediatric Dialysis, Department of Pediatrics, Azienda Ospedaliera Universitaria Sant'Orsola, Bologna, Italy;
Alberto EdefontiPediatric Nephrology and Dialysis Unit, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy;
Mirco BelingheriPediatric Nephrology and Dialysis Unit, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy;
Donatella De GiovanniDivision of Pediatrics, Hospital of Foggia, Foggia, Italy;
Giancarlo BarbanoDivision of Nephrology, Dialysis, Transplantation, Giannina Gaslini Children's Hospital, Genoa, Italy;
Ludovica Degl'InnocentiDivision of Nephrology, Dialysis, Transplantation, Giannina Gaslini Children's Hospital, Genoa, Italy;
Francesco ScolariDivision of Nephrology and Dialysis, Ospedale di Montichiari Azienda Ospedaliera Spedali Civili di Brescia, Brescia, Italy;
Luisa MurerPediatric Nephrology, Dialysis and Transplant Unit, Department of Pediatrics, University Hospital of Padua, Padua, Italy;
Jochen ReiserDepartment of Internal Medicine, Rush University Medical Center, Chicago, Illinois; and.
Alessia FornoniMiller School of Medicine, University of Miami, Miami, Florida.
Gian Marco GhiggeriDivision of Nephrology, Dialysis, Transplantation, Giannina Gaslini Children's Hospital, Genoa, Italy;
Children's Research Hospital · JPIstituto Giannina Gaslini · ITFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITPoliclinico S.Orsola-Malpighi · ITUniversity of Calgary · CAUniversity of Foggia · ITAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · ITRush University Medical Center · USUniversity of Miami · USUniversity of Padua · IT

Funding

Novel Targets of Rituximab in FSGSR01DK090316 · NIDDK · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI FORNONI, ALESSIA · 2011 to 2015
$1.7M
NIDDK NIH HHS R01 DK090316
6 · The paper itself

Abstract

Steroid-dependent nephrotic syndrome (SDNS) carries a high risk of toxicity from steroids or steroid-sparing agents. This open-label, noninferiority, randomized controlled trial at four sites in Italy tested whether rituximab is noninferior to steroids in maintaining remission in juvenile SDNS. We enrolled children age 1-16 years who had developed SDNS in the previous 6-12 months and were maintained in remission with high prednisone doses (≥0.7 mg/kg per day). We randomly assigned participants to continue prednisone alone for 1 month (control) or to add a single intravenous infusion of rituximab (375 mg/m(2); intervention). Prednisone was tapered in both groups after 1 month. For noninferiority, rituximab had to permit steroid withdrawal and maintain 3-month proteinuria (mg/m(2) per day) within a prespecified noninferiority margin of three times the levels among controls (primary outcome). We followed participants for ≥1 year to compare risk of relapse (secondary outcome). Fifteen children per group (21 boys; mean age, 7 years [range, 2.6-13.5 years]) were enrolled and followed for ≤60 months (median, 22 months). Three-month proteinuria was 42% lower in the rituximab group (geometric mean ratio, 0.58; 95% confidence interval, 0.18 to 1.95 [i.e., within the noninferiority margin of three times the levels in controls]). All but one child in the control group relapsed within 6 months; median time to relapse in the rituximab group was 18 months (95% confidence interval, 9 to 32 months). In the rituximab group, nausea and skin rash during infusion were common; transient acute arthritis occurred in one child. In conclusion, rituximab was noninferior to steroids for the treatment of juvenile SDNS.

Indexed as

AdolescentAnti-Inflammatory AgentsChildChild, PreschoolFemaleHumansImmunologic FactorsMaintenance ChemotherapyMaleNephrotic SyndromePrednisoneProteinuriaRecurrenceRituximabAnti-Inflammatory AgentsImmunologic FactorsPrednisoneRituximabnephrotic syndromeprimary glomerulonephritisrandomized controlled trials

Identifiers

PMID25592855
PMCPMC4552120
OpenAlexW2157484737

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.