Evidence map›Paper›PMID 30887675›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 in the prevention of antibody-mediated rejection in living-donor kidney transplant recipients requiring desensitization therapy: A randomized trial.

William H Marks, Nizam Mamode, Robert A Montgomery, Mark D Stegall, Lloyd E Ratner, Lynn D Cornell, Ajda T Rowshani, Robert B Colvin, Bradley Dain, Judith A Boice and 2 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter 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 trial NCT01399593 (A Randomized, Open-label, Multicenter Trial to Determine Safety and Efficacy of Eculizumab in the Prevention of Antibody Mediated Rejection), which is not on this map. Cited by 70 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
70citing papers in PubMed, 2 pooled it
13.1field-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.

NCT01399593 phase2terminatednot on this map

A Randomized, Open-label, Multicenter Trial to Determine Safety and Efficacy of Eculizumab in the Prevention of Antibody Mediated Rejection (AMR) in Living Donor Kidney Transplant Recipients Requiring Desensitization Therapy

TypeinterventionalSponsorAlexion Pharmaceuticals, Inc.Ran2011 to 2015Enrolled102ConditionsAntibody Mediated RejectionArmsEculizumab
3 · Its place in the literature

Who cites it

70 citing papers in PubMed, 2 syntheses or guidelines pooled it, 144 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. 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
  4. Safety and efficacy of eculizumab in the prevention of antibody-mediated rejection in living-donor kidney transplant recipients requiring desensitization therapy: A randomized trial.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2019
    Trial
  5. Article
  6. Review
  7. Complement activation in kidney transplantation.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2026
    Review
  8. Article
  9. Article
  10. Article
  11. Review
  12. Review
  13. Article
  14. Complement activation in secondary thrombotic microangiopathies.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2025
    Review
  15. Antibody-mediated rejection-treatment standard.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2025
    Review
  16. Review
  17. Review
  18. Review
  19. Post-transplant Thrombotic Microangiopathy.Journal of the American Society of Nephrology : JASN · 2025
    Review
  20. Review

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

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 at 8 institutions in 4 countries.

William H MarksFormerly Alexion Pharmaceuticals, Boston, Massachusetts.
Nizam MamodeDepartment of Transplant Surgery, Guy's and St Thomas', Evelina London Children's and Great Ormond Street Hospitals NHS Trust, London, UK.
Robert A MontgomeryNYU Langone Transplant Institute, New York University Langone Medical Center, New York, New York.
Mark D StegallThe William J. von Liebig Center for Transplantation and Clinical Regeneration and Division of Transplantation Surgery, Department of Surgery, Mayo Clinic, Rochester, Minnesota.
Lloyd E RatnerDepartment of Surgery, Columbia University, New York, New York.
Lynn D CornellDepartment of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota.
Ajda T RowshaniDepartment of Internal Medicine, Section of Nephrology and Transplantation, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.
Robert B ColvinDepartment of Pathology, Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts.
Bradley DainFormerly Alexion Pharmaceuticals, Boston, Massachusetts.
Judith A BoiceFormerly Alexion Pharmaceuticals, Boston, Massachusetts.
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.
C10-001 Study Group
Alexion Pharmaceuticals (United States) · USMayo Clinic · USAssistance Publique – Hôpitaux de Paris · FRColumbia University · USErasmus MC · NLHarvard University · USNYU Langone Health · USUniversity College London · GB

Funding

Alexion Pharmaceuticals
6 · The paper itself

Abstract

We report results of a phase 2, randomized, multicenter, open-label, two-arm study evaluating the safety and efficacy of eculizumab in preventing acute antibody-mediated rejection (AMR) in sensitized recipients of living-donor kidney transplants requiring pretransplant desensitization (NCT01399593). In total, 102 patients underwent desensitization. Posttransplant, 51 patients received standard of care (SOC) and 51 received eculizumab. The primary end point was week 9 posttransplant treatment failure rate, a composite of: biopsy-proven acute AMR (Banff 2007 grade II or III; assessed by blinded central pathology); graft loss; death; or loss to follow-up. Eculizumab was well tolerated with no new safety concerns. No significant difference in treatment failure rate was observed between eculizumab (9.8%) and SOC (13.7%; P = .760). To determine whether data assessment assumptions affected study outcome, biopsies were reanalyzed by central pathologists using clinical information. The resulting treatment failure rates were 11.8% and 21.6% for the eculizumab and SOC groups, respectively (nominal P = .288). When reassessment included grade I AMR, the treatment failure rates were 11.8% (eculizumab) and 29.4% (SOC; nominal P = .048). This finding suggests a potential benefit for eculizumab compared with SOC in preventing acute AMR in recipients sensitized to their living-donor kidney transplants (EudraCT 2010-019630-28).

Indexed as

AdolescentAdultAgedAntibodies, Monoclonal, HumanizedComplement Inactivating AgentsDesensitization, ImmunologicFemaleFollow-Up StudiesGraft RejectionGraft SurvivalHistocompatibility TestingHumansIsoantibodiesKidney Failure, ChronicKidney TransplantationLiving DonorsAntibodies, Monoclonal, HumanizedComplement Inactivating AgentseculizumabIsoantibodiesclinical research/practicecomplement biologydonors and donation: livingimmunosuppressant - fusion proteins and monoclonal antibodieskidney transplantation/nephrologyrejection: antibody-mediated (ABMR)sensitization

Identifiers

PMID30887675
PMCPMC6790671
OpenAlexW2923970214

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.