Evidence map›Paper›PMID 30615259›Full record

Trial reportAmerican journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons2019

A randomized trial of everolimus-based quadruple therapy vs standard triple therapy early after lung transplantation.

Jens Gottlieb, Claus Neurohr, Joachim Müller-Quernheim, Hubert Wirtz, Bjoern Sill, Heinrike Wilkens, Vasiliki Bessa, Christoph Knosalla, Martina Porstner, Carmen Capusan and 1 more

2 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 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.

NCT01404325 phase3completednot on this map

A 2-arm, Prospective, Randomized, Controlled, Open-label, 12 Month Phase III Trial to Evaluate the Efficacy Regarding Renal Function of Everolimus in Combination With a Centre Specific Standard Immunosuppressive Regimen Consisting of CNI, Purinantagonists and Steroids Versus a Standard Triple Immunosuppressive Regimen in Lung Transplant Recipients.

TypeinterventionalSponsorNovartis PharmaceuticalsRan2012 to 2017Enrolled130ConditionsLung TransplantationArmsstandard therapy, Everolimus
NCT04469842 early_phase1recruitingnot on this mapstarted 2023, after this paper: background citation

A Prospective, Randomized, Controlled Pilot Study of Early-Use Long Acting Tacrolimus (Envarsus XR) in Lung Transplant Recipients

TypeinterventionalSponsorVanderbilt University Medical CenterRan2023 to 2027Enrolled48ConditionsLung Transplant, ComplicationsArmsTacrolimus Extended Release Oral Tablet [Envarsus], Tacrolimus, Mycophenolate Mofetil Hydrochloride, Prednisone, Azathioprine
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. A randomized trial of everolimus-based quadruple therapy vs standard triple therapy early after lung transplantation.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2019
    Trial
  3. Article
  4. Kidney Biopsy Findings After Lung Transplantation.Kidney international reports · 2024
    Article
  5. Article
  6. Article
  7. Review
  8. Rescue Everolimus Post Lung Transplantation is Not Associated With an Increased Incidence of CLAD or CLAD-Related Mortality.Transplant international : official journal of the European Society for Organ Transplantation · 2023
    Article
  9. Article
  10. Review
  11. Immunosuppression in Lung Transplantation.Handbook of experimental pharmacology · 2022
    Review
  12. Article
  13. Observational
  14. Developments in lung transplantation over the past decade.European respiratory review : an official journal of the European Respiratory Society · 2020
    Review
  15. Immunosuppressive strategies in lung transplantation.Annals of translational medicine · 2020
    Review
  16. 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

11 authors.

Jens GottliebDepartment of Respiratory Medicine, Hannover Medical School, Hannover, Germany.
Claus NeurohrGrosshadern Medical Clinic and Policlinic V, LMU Munich University Hospital, Munich, Germany.
Joachim Müller-QuernheimPulmonology Medical Clinic, Freiburg University Hospital, Freiburg, Germany.
Hubert WirtzInternal Medicine/Department of Pneumology, Leipzig University Hospital, Leipzig, Germany.
Bjoern SillDepartment of Cardiovascular Surgery, Hamburg-Eppendorf University Hospital, Hamburg, Germany.
Heinrike WilkensInternal Medicine V, University Hospital of Saarland, Homburg Saar, Germany.
Vasiliki BessaDepartment of Pneumology, Ruhrlandklinik, West German Center for Lung Transplantation, University Hospital Essen, University Duisburg-Essen, Essen, Germany.
Christoph KnosallaDepartment of Cardiothoracic and Vascular Surgery, German Heart Institute Berlin, DZHK (German Center for Cardiovascular Research), Berlin, Germany.
Martina PorstnerNovartis Pharma GmbH, Nuremberg, Germany.
Carmen CapusanNovartis Pharma GmbH, Nuremberg, Germany.
Martin StrüberDepartment of Cardiothoracic Surgery, Newark Beth Israel Medical Center, Children's Hospital of New Jersey, Newark, New Jersey.

Funding

Novartis Pharma GmbH, Nuremberg, Germany
6 · The paper itself

Abstract

Calcineurin inhibitor (CNI) therapy after lung transplantation increases risk of kidney failure. Early everolimus-based quadruple low CNI immunosuppression may improve renal function without compromising efficacy or safety. A prospective, randomized, open-label, 12-month multicenter trial was conducted at 8 German sites. Patients 3-18 months after lung transplantation were randomized (1:1), stratified by baseline estimated glomerular filtration rate (eGFR). In the quadruple low CNI regimen, patients received everolimus (target trough level 3-5 ng/mL) with reduced CNI (tacrolimus 3-5 ng/mL or cyclosporine 25-75 ng/mL) and a cell cycle inhibitor plus prednisone. In the standard triple CNI regimen, patients received tacrolimus (target trough level >5 ng/mL) or cyclosporine (>100 ng/mL) and a cell cycle inhibitor plus prednisone. Of the 180 patients screened, 130 were randomized: 67 in the quadruple low CNI group and 63 in the standard triple CNI group. The primary endpoint (eGFR after 12 months) demonstrated superiority of the quadruple low CNI regimen: 64.5 mL/min vs 54.6 mL/min for the standard triple group (least squares mean, analysis of covariance; P < .001). Key efficacy parameters (biopsy-proven acute rejection, chronic lung allograft dysfunction, and death) and safety endpoints were similar between both groups. Quadruple low CNI immunosuppression early after lung transplantation was demonstrated to be efficacious and safe. Clinical trials registry: ClinicalTrials.gov NCT01404325.

Indexed as

Lung TransplantationCalcineurin InhibitorsDrug Administration ScheduleEverolimusFemaleGermanyGlomerular Filtration RateGraft RejectionGraft SurvivalHumansImmunosuppressive AgentsKidneyMaleMiddle AgedProspective StudiesTreatment OutcomeCalcineurin InhibitorsEverolimusImmunosuppressive Agentsclinical research/practicecyclosporine A (CsA)everolimusimmunosuppressant - calcineurin inhibitorimmunosuppressant - mechanistic target of rapamycinimmunosuppressant - mechanistic target of rapamycin (mTOR)immunosuppression/immune modulationlung transplantation/pulmonologyrejectiontacrolimus

Identifiers

PMID30615259
PMCPMC6590654

What OpenQuestion holds

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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.