Evidence map›Paper›PMID 38993854›Full record

ArticleFrontiers in transplantation2023

Impact of everolimus plus calcineurin inhibitor on formation of non-HLA antibodies and graft outcomes in kidney transplant recipients: 12-month results from the ATHENA substudy.

Aurélie Philippe, Wolfgang Arns, Vanessa Ditt, Ingeborg A Hauser, Friedrich Thaiss, Claudia Sommerer, Barbara Suwelack, Duska Dragun, Jan Hillen, Christiane Schiedel and 2 more

Registry-linked trialAbstract read
In one paragraph

Article in Frontiers in transplantation, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01843348 (12 Month, Multi-center, Open-label, Prospective, Randomized, Parallel Group Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a Certican® Based Regimen Either in Combination With Cyclosporin A or Tacrolimus), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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.

NCT01843348 phase3completednot on this map

12 Month, Multi-center, Open-label, Prospective, Randomized, Parallel Group Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a Certican® Based Regimen Either in Combination With Cyclosporin A or Tacrolimus

TypeinterventionalSponsorNovartis PharmaceuticalsRan2012 to 2016Enrolled612ConditionsKidney Transplantation, Renal TransplantationArmsEverolimus, Tacrolimus, Cyclosporin A, Enteric Coated Mycophenolate Sodium (EC-MPS), Mycophenolate mofetil (MMF)
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Antibodies to angiotensin II type 1 receptor and endothelin type A receptor are associated with cytokine production enriched for type 2 immune response and antibody production in pediatric kidney transplant recipients.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2025
    Article
  2. Article
  3. Everolimus plus reduced calcineurin inhibitor preventsFrontiers in transplantation · 2023
    Article
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.

Aurélie PhilippeBIH Biomedical Innovation Academy, Berlin Institute of Health at Charité-Universitätsmedizin Berlin, Berlin, Germany.
Wolfgang ArnsTransplant Centre Cologne, Cologne General Hospital, Cologne, Germany.
Vanessa DittInstitute of Transfusion Medicine, Kliniken der Stadt Köln, Cologne, Germany.
Ingeborg A HauserDepartment of Nephrology, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt, Germany.
Friedrich ThaissIII. Department of Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Claudia SommererNephrology, Kidney Center Heidelberg, University Hospital Heidelberg, Heidelberg, Germany.
Barbara SuwelackDepartment of Internal Medicine, Transplant Nephrology, University Hospital of Münster, Münster, Germany.
Duska DragunBIH Biomedical Innovation Academy, Berlin Institute of Health at Charité-Universitätsmedizin Berlin, Berlin, Germany.
Jan HillenImmunology, Novartis Pharma GmbH, Nürnberg, Germany.
Christiane SchiedelImmunology, Novartis Pharma GmbH, Nürnberg, Germany.
Anja ElsässerImmunology, Novartis Pharma GmbH, Nürnberg, Germany.
Björn NashanDepartment of Hepatobiliary Surgery and Visceral Transplantation, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Non-human leukocyte antigen (non-HLA) antibodies including antibodies targeting Angiotensin II type 1 (AT1R) and Endothelin-1 type A (ETAR) receptors represent a topic of interest in kidney transplantation (KTx). This exploratory substudy evaluated the impact of everolimus (EVR) or mycophenolic acid (MPA) in combination with tacrolimus (TAC) or cyclosporine A (CsA) in patients with preformed non-HLA antibodies, potentially associated rejections and/or their impact on renal function over 1 year. Methods: All eligible patients were randomized (1:1:1) before transplantation to receive either EVR/TAC, EVR/CsA, or MPA/TAC regimen. The effect of these regimens on the formation of non-HLA antibodies within one year post Results: At Month 12, in EVR/TAC group, higher incidence of patients negative for AT1R- and ETAR-antibodies (82.2% and 76.7%, respectively) was noted, whereas the incidence of AT1R- and ETAR-antibodies positivity (28.1% and 34.7%, respectively) was higher in the MPA/TAC group. Non-HLA antibodies had no influence on clinical outcomes in any treatment group and no graft loss or death was reported. Conclusions: The studied combinations of immunosuppressants were safe with no influence on clinical outcomes and suggested minimal exposure of calcineurin inhibitors for better patient management. Clinical Trial Registration: https://clinicaltrials.gov/ (NCT01843348; EudraCT number: 2011-005238-21).

Indexed as

angiotensin II type 1 receptorendothelin-1 type A receptoreverolimuskidney transplantationnon-human leukocyte antigen

Identifiers

PMID38993854
PMCPMC11235374

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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.