Evidence map›Paper›PMID 34845071›Full record

ArticleBMJ open2021

Randomised controlled trial comparing rituximab to mycophenolate mofetil in children and young adults with steroid-dependent idiopathic nephrotic syndrome: study protocol.

Francesca Lugani, Andrea Angeletti, Pietro Ravani, Marina Vivarelli, Manuela Colucci, Gianluca Caridi, Enrico Verrina, Francesco Emma, Gian Marco Ghiggeri

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 22% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Single (375 mg/mPediatric nephrology (Berlin, Germany) · 2025
    Article
  4. Observational
  5. Review
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

9 authors at 3 institutions in 2 countries.

Francesca Lugani *Laboratory on Molecular Nephrology, Division of Nephrology, Dialysis, Transplantation, Istituto Giannina Gaslini Istituto di Ricovero e Cura a Carattere Scientifico, Genova, Italy.
Andrea Angeletti *Laboratory on Molecular Nephrology, Division of Nephrology, Dialysis, Transplantation, Istituto Giannina Gaslini Istituto di Ricovero e Cura a Carattere Scientifico, Genova, Italy.ORCID 0000-0002-6121-5326
Pietro RavaniDivision of Nephrology, University of Calgary, Calgary, Alberta, Canada.
Marina VivarelliDivision of Nephrology, Bambino Gesù Children's Hospital Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy.
Manuela ColucciRenal Diseases Research Unit, Genetics and Rare Diseases Division, Bambino Gesù Children's Hospital Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy.
Gianluca CaridiLaboratory on Molecular Nephrology, Division of Nephrology, Dialysis, Transplantation, Istituto Giannina Gaslini Istituto di Ricovero e Cura a Carattere Scientifico, Genova, Italy.
Enrico VerrinaDivision of Nephrology, Dialysis and Transplantation, Istituto Giannina Gaslini Istituto Pediatrico di Ricovero e Cura a Carattere Scientifico, Genova, Italy.
Francesco EmmaDivision of Nephrology, Bambino Gesù Children's Hospital Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy.
Gian Marco GhiggeriLaboratory on Molecular Nephrology, Division of Nephrology, Dialysis, Transplantation, Istituto Giannina Gaslini Istituto di Ricovero e Cura a Carattere Scientifico, Genova, Italy gmarcoghiggeri@gaslini.org.
Istituto Giannina Gaslini · ITBambino Gesù Children's Hospital · ITUniversity of Calgary · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionGlucocorticoids induce remission in 90% of children with idiopathic nephrotic syndrome (INS). Some become steroid-dependent (SD) and require the addition of steroid sparing drugs such as calcineurin-inhibitors (CNI) or cyclophosphamide, to maintain remission. Considering the toxicity of these drugs, alternative interventions are needed for long-term treatment. The anti-CD20 antibody rituximab has shown promising steroid-sparing properties, with conflicting results in complicated forms of SD-INS. Mycophenolate mofetil (MMF) resulted effective in maintaining free-steroid remission, however, studies are limited to few uncontrolled trials with reported different dose of MMF. METHODS AND ANALYSIS: This open-label, two-parallel-arm, superiority controlled randomised clinical trial will enrol children with SD-INS maintained in remission with oral glucocorticoids or CNI. Children and young adults will be randomised to either MMF (1.200 mg/m ETHICS AND DISSEMINATION: The trial was approved by the local ethics boards (Comitato Etico Regione Liguria CER Liguria https://www.portalericerca-liguria.it/). We will publish the study results at international scientific meetings. TRIAL REGISTRATION NUMBERS: NCT004585152.

Indexed as

Mycophenolic AcidNephrotic SyndromeChildEquivalence Trials as TopicHumansImmunosuppressive AgentsRandomized Controlled Trials as TopicRecurrenceRituximabSteroidsTreatment OutcomeYoung AdultImmunosuppressive AgentsMycophenolic AcidRituximabSteroidsclinical pharmacologyclinical trialsglomerulonephritisimmunologynephrologypaediatric nephrology

Identifiers

PMID34845071
PMCPMC8634023
OpenAlexW3217805933

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.