Evidence map›Paper›PMID 31993781›Full record

Trial reportPediatric nephrology (Berlin, Germany)2020

Low-dose ofatumumab for multidrug-resistant nephrotic syndrome in children: a randomized placebo-controlled trial.

Pietro Ravani, Isabella Pisani, Monica Bodria, Gianluca Caridi, Maria Ludovica Degl'Innocenti, Gian Marco Ghiggeri

Registry-linked trialAbstract readRandomized Controlled 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. It is linked to trial NCT02394106 (Ofatumumab in Children With Steroid- and Calcineurin-inhibitor-resistant Nephrotic Syndrome), which is not on this map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
2.8field-weighted citation impact, top 9% 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
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 29 citations in OpenAlex.

  1. Pooled it
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  3. B-cell-targeting therapies in podocytopathies.Pediatric nephrology (Berlin, Germany) · 2026
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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

6 authors at 3 institutions in 2 countries.

Pietro RavaniDepartment of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
Isabella PisaniDivision of Nephrology, School of Nephrology, Department of Medicine and Surgery, University of Parma, Parma, Italy.
Monica BodriaLaboratory of Molecular Nephrology and Division of Nephrology and Transplantation, IRCCS Istituto Giannina Gaslini, Largo G. Gaslini 5, Genoa, Italy.
Gianluca CaridiLaboratory of Molecular Nephrology and Division of Nephrology and Transplantation, IRCCS Istituto Giannina Gaslini, Largo G. Gaslini 5, Genoa, Italy.
Maria Ludovica Degl'InnocentiLaboratory of Molecular Nephrology and Division of Nephrology and Transplantation, IRCCS Istituto Giannina Gaslini, Largo G. Gaslini 5, Genoa, Italy.
Gian Marco GhiggeriLaboratory of Molecular Nephrology and Division of Nephrology and Transplantation, IRCCS Istituto Giannina Gaslini, Largo G. Gaslini 5, Genoa, Italy. gmarcoghiggeri@gaslini.org.ORCID http://orcid.org/0000-0003-3659-9062
Istituto Giannina Gaslini · ITUniversity of Calgary · CAUniversity of Parma · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChildren with multidrug-resistant nephrotic syndrome (MRNS) are exposed to drug toxicity (steroids/calcineurin inhibitors (CNI)/mycophenolate mofetil (MMF)) and have an increased risk of kidney disease progression. In small case series, the fully humanized anti-CD20 antibody ofatumumab (OFA) induced remission in children with MRNS when at high dose (10,300 mg/1.73 m

methodsThis double-blind randomized placebo-controlled trial tested the efficacy of single infusion OFA in children with proven MRNS and initial chronic renal failure (eGFR [median/range] 119/38-155 ml/min/1.73 m

resultsAfter 13 of the planned 50 children (25%) were randomized, the data safety and monitoring board recommended study termination for futility. All 13 children remained nephrotic. Renal function worsened in 5 children (2 in Intervention arm, 3 in Placebo arm) who required renal replacement therapy during the study period. Circulating CD20 was reduced following OFA infusion and remained low for > 3 months.

conclusionsOFA given in one single infusion of 1500 mg/1.73 m

trial registrationhttps://clinicaltrials.gov: NCT02394106.

Indexed as

AdolescentAntibodies, Monoclonal, HumanizedChildChild, PreschoolDouble-Blind MethodDrug Resistance, MultipleFemaleHumansInfusions, IntravenousMaleNephrotic SyndromeRemission InductionTreatment FailureAntibodies, Monoclonal, HumanizedofatumumabChildrenMultidrug-resistant nephrotic syndromeOfatumumabRemission

Identifiers

PMID31993781
OpenAlexW3003209155

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.