Evidence map›Paper›PMID 23813218›Full record

Trial reportJournal of the American Society of Nephrology : JASN2013

Mycophenolate mofetil versus cyclosporin A in children with frequently relapsing nephrotic syndrome.

Jutta Gellermann, Lutz Weber, Lars Pape, Burkhard Tönshoff, Peter Hoyer, Uwe Querfeld, Gesellschaft für Pädiatrische Nephrologie (GPN)

Registry-linked trialOpen access · greenAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American Society of Nephrology : JASN, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04048161 (Study of Tacrolimus vs Mycophenolate Mofetil in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome), which is not on this map. Cited by 64 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed, 6 pooled it
7.1field-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.

NCT04048161 phase4completednot on this mapstarted 2019, after this paper: background citation

Study of Tacrolimus vs Mycophenolate Mofetil in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome: a Randomized, Multicenter, Open-label, Parallel-arm Study

TypeinterventionalSponsorThe Children's Hospital of Zhejiang University School of MedicineRan2019 to 2023Enrolled270ConditionsNephrotic Syndrome in ChildrenArmsTacrolimus, Mycophenolate Mofetil
3 · Its place in the literature

Who cites it

64 citing papers in PubMed, 6 syntheses or guidelines pooled it, 158 citations in OpenAlex.

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  15. KDOQI US Commentary on the KDIGO 2025 Clinical Practice Guideline for the Management of Nephrotic Syndrome in Children.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2026
    Review
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4 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

7 authors at 5 institutions in 1 country.

Jutta GellermannDepartment of Pediatric Nephrology, Charité Universitätsmedizin Berlin CVK, Berlin, Germany;
Lutz Weber
Lars Pape
Burkhard Tönshoff
Peter Hoyer
Uwe Querfeld
Gesellschaft für Pädiatrische Nephrologie (GPN)
Charité - Universitätsmedizin Berlin · DEMedizinische Hochschule Hannover · DEUniversity Hospital Heidelberg · DEUniversity of Cologne · DEUniversity of Duisburg-Essen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The severe side effects of long-term corticosteroid or cyclosporin A (CsA) therapy complicate the treatment of children with frequently relapsing steroid-sensitive nephrotic syndrome (FR-SSNS). We conducted a randomized, multicenter, open-label, crossover study comparing the efficacy and safety of a 1-year treatment with mycophenolate mofetil (MMF; target plasma mycophenolic acid trough level of 1.5-2.5 µg/ml) or CsA (target trough level of 80-100 ng/ml) in 60 pediatric patients with FR-SSNS. We assessed the frequency of relapse as the primary endpoint and evaluated pharmacokinetic profiles (area under the curve [AUC]) after 3 and 6 months of treatment. More relapses per patient per year occurred with MMF than with CsA during the first year (P=0.03), but not during the second year (P=0.14). No relapses occurred in 85% of patients during CsA therapy and in 64% of patients during MMF therapy (P=0.06). However, the time without relapse was significantly longer with CsA than with MMF during the first year (P<0.05), but not during the second year (P=0.36). In post hoc analysis, patients with low mycophenolic acid exposure (AUC <50 µg⋅h/ml) experienced 1.4 relapses per year compared with 0.27 relapses per year in those with high exposure (AUC>50 µg⋅h/ml; P<0.05). There were no significant differences between groups with respect to BP, growth, lipid levels, or adverse events. However, cystatin clearance, estimated GFR, and hemoglobin levels increased significantly with MMF compared with CsA. These results indicate that MMF is inferior to CsA in preventing relapses in pediatric patients with FR-SSNS, but may be a less nephrotoxic treatment option.

Indexed as

AdolescentBlood PressureChildCross-Over StudiesCyclosporineFemaleGlucocorticoidsHemoglobinsHumansImmunosuppressive AgentsKidney Function TestsLipidsMaleMycophenolic AcidNephrotic SyndromePrednisoneCyclosporineGlucocorticoidsHemoglobinsImmunosuppressive AgentsLipidsMycophenolic AcidPrednisone

Identifiers

PMID23813218
PMCPMC3785276
OpenAlexW2171767062

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.