Evidence map›Paper›PMID 19369404›Full record

Trial reportJournal of the American Society of Nephrology : JASN2009

Mycophenolate mofetil versus cyclophosphamide for induction treatment of lupus nephritis.

Gerald B Appel, Gabriel Contreras, Mary Anne Dooley, Ellen M Ginzler, David Isenberg, David Jayne, Lei-Shi Li, Eduardo Mysler, Jorge Sánchez-Guerrero, Neil Solomons and 2 more

3 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the American Society of Nephrology : JASN, 2009. 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 376 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
376citing papers in PubMed, 11 pooled it
51.3field-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.

NCT02141672 phase2completednot on this mapstarted 2014, after this paper: background citation

A Randomized, Controlled Double-blind Study Comparing the Efficacy and Safety of Voclosporin (23.7 mg BID, or 39.5 mg BID) With Placebo in Achieving Remission in Patients With Active Lupus Nephritis

TypeinterventionalSponsorAurinia Pharmaceuticals Inc.Ran2014 to 2017Enrolled265ConditionsLupus NephritisArmsVoclosporin High Dose, Voclosporin Low Dose, Placebo
NCT03492255 naterminatednot on this mapstarted 2018, after this paper: background citation

CYCLONES - CYClophosphamide LOw Dose and No Extra Steroid

TypeinterventionalSponsorUniversity of Sao Paulo General HospitalRan2018 to 2021Enrolled49ConditionsSystemic Lupus Erythematosus (SLE)ArmsCyclophosphamide, Methylprednisolone, Prednisone, Mycophenolate Mofetil
NCT04146220 phase4completednot on this mapstarted 2018, after this paper: background citation

Efficacy of Lower Dose Prednisolone in the Induction of Remission of Lupus Nephritis

TypeinterventionalSponsorBangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshRan2018 to 2019Enrolled32ConditionsLupus NephritisArmsPrednisolone
3 · Its place in the literature

Who cites it

376 citing papers in PubMed, 11 syntheses or guidelines pooled it, 1,093 citations in OpenAlex.

  1. Guideline
  2. Pooled it
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  11. Immunosuppressive treatment for proliferative lupus nephritis.The Cochrane database of systematic reviews · 2018
    Pooled it
  12. Trial
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  18. Trial
  19. Trial
  20. Review

316 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 3 institutions in 2 countries.

Gerald B AppelDepartment of Nephrology, Columbia University, New York, New York, USA.
Gabriel Contreras
Mary Anne Dooley
Ellen M Ginzler
David Isenberg
David Jayne
Lei-Shi Li
Eduardo Mysler
Jorge Sánchez-Guerrero
Neil Solomons
David Wofsy
Aspreva Lupus Management Study Group
SUNY Downstate Health Sciences University · USAddenbrooke's Hospital · GBUniversity College London · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Recent studies have suggested that mycophenolate mofetil (MMF) may offer advantages over intravenous cyclophosphamide (IVC) for the treatment of lupus nephritis, but these therapies have not been compared in an international randomized, controlled trial. Here, we report the comparison of MMF and IVC as induction treatment for active lupus nephritis in a multinational, two-phase (induction and maintenance) study. We randomly assigned 370 patients with classes III through V lupus nephritis to open-label MMF (target dosage 3 g/d) or IVC (0.5 to 1.0 g/m(2) in monthly pulses) in a 24-wk induction study. Both groups received prednisone, tapered from a maximum starting dosage of 60 mg/d. The primary end point was a prespecified decrease in urine protein/creatinine ratio and stabilization or improvement in serum creatinine. Secondary end points included complete renal remission, systemic disease activity and damage, and safety. Overall, we did not detect a significantly different response rate between the two groups: 104 (56.2%) of 185 patients responded to MMF compared with 98 (53.0%) of 185 to IVC. Secondary end points were also similar between treatment groups. There were nine deaths in the MMF group and five in the IVC group. We did not detect significant differences between the MMF and IVC groups with regard to rates of adverse events, serious adverse events, or infections. Although most patients in both treatment groups experienced clinical improvement, the study did not meet its primary objective of showing that MMF was superior to IVC as induction treatment for lupus nephritis.

Indexed as

CyclophosphamideEthnicityFemaleGlomerular Filtration RateHumansImmunosuppressive AgentsInjections, IntravenousLupus NephritisMaleMycophenolic AcidRacial GroupsTreatment OutcomeCyclophosphamideImmunosuppressive AgentsMycophenolic Acid

Identifiers

PMID19369404
PMCPMC2678035
OpenAlexW2171121999

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.