Evidence map›Paper›PMID 31012541›Full record

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

Safety and efficacy of eculizumab for the prevention of antibody-mediated rejection after deceased-donor kidney transplantation in patients with preformed donor-specific antibodies.

Denis Glotz, Graeme Russ, Lionel Rostaing, Christophe Legendre, Gunnar Tufveson, Steve Chadban, Josep Grinyó, Nizam Mamode, Paolo Rigotti, Lionel Couzi and 8 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
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. Cited by 36 papers.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed
10.2field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 89 citations in OpenAlex.

  1. Safety and efficacy of eculizumab for the prevention of antibody-mediated rejection after deceased-donor kidney transplantation in patients with preformed donor-specific antibodies.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2019
    Trial
  2. Complement activation in kidney transplantation.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2026
    Review
  3. Complement activation in secondary thrombotic microangiopathies.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2025
    Review
  4. Review
  5. Article
  6. European Consensus on the Management of Sensitized Kidney Transplant Recipients: A Delphi Study.Transplant international : official journal of the European Society for Organ Transplantation · 2024
    Article
  7. Article
  8. Review
  9. Complement Inhibition in Kidney Transplantation: Where Are We Now?BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023
    Review
  10. Article
  11. Imlifidase for Kidney Transplantation of Highly Sensitized Patients With a Positive Crossmatch: The French Consensus Guidelines.Transplant international : official journal of the European Society for Organ Transplantation · 2023
    Article
  12. Article
  13. Review
  14. Review
  15. Review
  16. Article
  17. Article
  18. Induction Therapy and Therapeutic Antibodies.Handbook of experimental pharmacology · 2022
    Article
  19. Review
  20. 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

18 authors at 14 institutions in 7 countries.

Denis GlotzParis Translational Research Center for Organ Transplantation, Institut National de la Santé et de la Recherche Médicale, Unité Mixte de Recherche-S970, Paris, France.
Graeme RussCentral and Northern Adelaide Renal and Transplantation Services, Royal Adelaide Hospital and University of Adelaide, Adelaide, South Australia, Australia.
Lionel RostaingFormerly Department of Nephrology and Organ Transplantation, Rangueil University Hospital Center, Toulouse, France.
Christophe LegendreAdult Nephrology Transplantation Service, Hôpital Necker-Enfants Malades, Université Paris Descartes, Sorbonne Paris Cité, Paris, France.ORCID 0000-0002-1743-2948
Gunnar TufvesonSection of Transplantation Surgery, Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.
Steve ChadbanDepartment of Renal Medicine, Royal Prince Alfred Hospital, University of Sydney, Sydney, New South Wales, Australia.
Josep GrinyóDepartment of Nephrology, Hospital Universitari de Bellvitge, University of Barcelona, Barcelona, Spain.
Nizam MamodeDepartment of Transplant Surgery, Guy's and St Thomas', Evelina London Children's and Great Ormond Street Hospitals NHS Trust, London, UK.
Paolo RigottiKidney and Pancreas Transplant Unit, University Hospital of Padua, Padua, Italy.
Lionel CouziUMR CNRS 5164, ImmunoConcEpT, Bordeaux University, Bordeaux, France.
Matthias BüchlerDepartment of Nephrology, Tours University Hospital, Tours, France.
Silvio SandriniDivision of Nephrology, University of Brescia and Spedali Civili General Hospital, Brescia, Italy.
Bradley DainFormerly Alexion Pharmaceuticals, Boston, Massachusetts.
Mary GarfieldFormerly Alexion Pharmaceuticals, Boston, Massachusetts.
Masayo OgawaAlexion Pharmaceuticals, Boston, Massachusetts.
Tristan RichardFormerly Alexion Pharmaceuticals, Boston, Massachusetts.
William H MarksFormerly Alexion Pharmaceuticals, Boston, Massachusetts.
C10-002 Study Group
Alexion Pharmaceuticals (United States) · USAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · ITBellevue College · USBellvitge University Hospital · ESCentre National de la Recherche Scientifique · FRGreat Ormond Street Hospital · GBHôpital Necker-Enfants Malades · FRHôpital Rangueil · FRInserm · FRRoyal Adelaide Hospital · AUThe University of Sydney · AUUniversité de Tours · FRUniversity of Padua · ITUppsala University · SE

Funding

Alexion Pharmaceuticals, Inc.
6 · The paper itself

Abstract

The presence of preformed donor-specific antibodies in transplant recipients increases the risk of acute antibody-mediated rejection (AMR). Results of an open-label single-arm trial to evaluate the safety and efficacy of eculizumab in preventing acute AMR in recipients of deceased-donor kidney transplants with preformed donor-specific antibodies are reported. Participants received eculizumab as follows: 1200 mg immediately before reperfusion; 900 mg on posttransplant days 1, 7, 14, 21, and 28; and 1200 mg at weeks 5, 7, and 9. All patients received thymoglobulin induction therapy and standard maintenance immunosuppression including steroids. The primary end point was treatment failure rate, a composite of biopsy-proved grade II/III AMR (Banff 2007 criteria), graft loss, death, or loss to follow-up, within 9 weeks posttransplant. Eighty patients received transplants (48 women); the median age was 52 years (range 24-70 years). Observed treatment failure rate (8.8%) was significantly lower than expected for standard care (40%; P < .001). By 9 weeks, 3 of 80 patients had experienced AMR, and 4 of 80 had experienced graft loss. At 36 months, graft and patient survival rates were 83.4% and 91.5%, respectively. Eculizumab was well tolerated and no new safety concerns were identified. Eculizumab has the potential to provide prophylaxis against injury caused by acute AMR in such patients (EudraCT 2010-019631-35).

Indexed as

AdolescentAdultAgedAntibodies, Monoclonal, HumanizedComplement Inactivating AgentsFemaleFollow-Up StudiesGraft RejectionGraft SurvivalHumansIsoantibodiesKidney Failure, ChronicKidney TransplantationMaleMiddle AgedPatient SafetyAntibodies, Monoclonal, HumanizedComplement Inactivating AgentseculizumabIsoantibodiesclinical research/practicecomplement biologydonors and donation: deceasedimmunosuppressant-fusion proteins and monoclonal antibodieskidney transplantation/nephrologyrejection: antibody-mediated (ABMR)sensitization

Identifiers

PMID31012541
PMCPMC9328661
OpenAlexW2942193435

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.