Evidence map›Paper›PMID 31492152›Full record

Trial reportBMC nephrology2019

Mycophenolate mofetil and tacrolimus versus tacrolimus alone for the treatment of idiopathic membranous glomerulonephritis: a randomised controlled trial.

Aikaterini Nikolopoulou, Marie Condon, Tabitha Turner-Stokes, H Terence Cook, Neill Duncan, Jack W Galliford, Jeremy B Levy, Liz Lightstone, Charles D Pusey, Candice Roufosse and 2 more

Registry-linked trialAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC nephrology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00843856 (Mycophenolate Mofetil and Tacrolimus vs Tacrolimus Alone for the Treatment of Idiopathic Membranous Glomerulonephritis), which is not on this map. Cited by 6 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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.

NCT00843856 phase4completednot on this map

Mycophenolate Mofetil and Tacrolimus vs Tacrolimus Alone for the Treatment of Idiopathic Membranous Glomerulonephritis (IMG)

TypeinterventionalSponsorImperial College Healthcare NHS TrustRan2009 to 2018Enrolled40ConditionsGlomerulonephritis, MembranousArmstacrolimus, tacrolimus and mycophenolate mofetil
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Review
  6. 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

12 authors.

Aikaterini NikolopoulouCentre for Inflammatory Disease, Division of Immunology and Inflammation, Department of Medicine, Imperial College London, Du Cane Road, London, W12 0NN, UK. lina.nikolopoulou13@imperial.ac.uk.ORCID 0000-0001-9442-0134
Marie CondonImperial College Renal and Transplant Centre, Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, W12 0NN, UK.
Tabitha Turner-StokesCentre for Inflammatory Disease, Division of Immunology and Inflammation, Department of Medicine, Imperial College London, Du Cane Road, London, W12 0NN, UK.
H Terence CookCentre for Inflammatory Disease, Division of Immunology and Inflammation, Department of Medicine, Imperial College London, Du Cane Road, London, W12 0NN, UK.
Neill DuncanImperial College Renal and Transplant Centre, Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, W12 0NN, UK.
Jack W GallifordImperial College Renal and Transplant Centre, Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, W12 0NN, UK.
Jeremy B LevyImperial College Renal and Transplant Centre, Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, W12 0NN, UK.
Liz LightstoneCentre for Inflammatory Disease, Division of Immunology and Inflammation, Department of Medicine, Imperial College London, Du Cane Road, London, W12 0NN, UK.
Charles D PuseyCentre for Inflammatory Disease, Division of Immunology and Inflammation, Department of Medicine, Imperial College London, Du Cane Road, London, W12 0NN, UK.
Candice RoufosseCentre for Inflammatory Disease, Division of Immunology and Inflammation, Department of Medicine, Imperial College London, Du Cane Road, London, W12 0NN, UK.
Thomas D CairnsImperial College Renal and Transplant Centre, Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, W12 0NN, UK.
Megan E GriffithImperial College Renal and Transplant Centre, Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, W12 0NN, UK.

Funding

Department of Health
6 · The paper itself

Abstract

backgroundTacrolimus (TAC) is effective in treating membranous nephropathy (MN); however relapses are frequent after treatment cessation. We conducted a randomised controlled trial to examine whether the addition of mycophenolate mofetil (MMF) to TAC would reduce relapse rate.

methodsForty patients with biopsy proven idiopathic MN and nephrotic syndrome were randomly assigned to receive either TAC monotherapy (n = 20) or TAC combined with MMF (n = 20) for 12 months. When patients had been in remission for 1 year on treatment the MMF was stopped and the TAC gradually withdrawn in both groups over 6 months. Patients also received supportive treatment with angiotensin blockade, statins, diuretics and anticoagulation as needed. Primary endpoint was relapse rate following treatment withdrawal. Secondary outcomes were remission rate, time to remission and change in renal function.

results16/20 (80%) of patients in the TAC group achieved remission compared to 19/20 (95%) in the TAC/MMF group (p = 0.34). The median time to remission in the TAC group was 54 weeks compared to 40 weeks in the TAC/MMF group (p = 0.46). There was no difference in the relapse rate between the groups: 8/16 (50%) patients in the TAC group relapsed compared to 8/19 (42%) in the TAC/MMF group (p = 0.7). The addition of MMF to TAC did not adversely affect the safety of the treatment.

conclusionsAddition of MMF to TAC does not alter the relapse rate of nephrotic syndrome in patients with MN.

trial registrationThis trial is registered with EudraCTN2008-001009-41 . Trial registration date 2008-10-08.

Indexed as

AdultAgedDrug Therapy, CombinationFemaleGlomerulonephritis, MembranousHumansImmunosuppressive AgentsMaleMiddle AgedMycophenolic AcidRecurrenceRemission InductionTacrolimusYoung AdultImmunosuppressive AgentsMycophenolic AcidTacrolimusMembranous nephropathyMycophenolate mofetilNephrotic syndromeRandomised controlled trialRelapseTacrolimus

Identifiers

PMID31492152
PMCPMC6731553

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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.