Evidence map›Paper›PMID 39534185›Full record

ArticleKidney international reports2024

Open-Label Phase 1/2 Study of Daratumumab-Based Desensitization Before Kidney Transplantation.

Caroline Pilon, Nizar Joher, Cédric Usureau, Emmanuelle Boutin, Anna Boueilh, Jean-Luc Taupin, Allan Thiolat, José L Cohen, Vissal David Kheav, Florence Canoui-Poitrine and 3 more

Abstract read
In one paragraph

Article in Kidney international reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing 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.

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

16 citing papers in PubMed.

  1. Article
  2. Biologics in Kidney Transplantation: Why and How Should We Personalize Their Dosage?BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026
    Review
  3. Article
  4. Impact and outcomes after desensitization therapy in highly sensitized heart transplant candidates.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2026
    Article
  5. Article
  6. Article
  7. Review
  8. Review
  9. Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. Review
  15. Review
  16. Targeting CD38 in Antibody-Mediated Rejection.Transplant international : official journal of the European Society for Organ Transplantation · 2025
    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

13 authors.

Caroline PilonUniversite Paris Est Creteil, INSERM IMRB U955, Créteil, France.
Nizar JoherDepartment of Nephrology and Renal Transplantation, Assistance Publique-Hôpitaux de Paris, Groupe hospitalo-universitaire Chenevier Mondor, Fédération Hospitalo-Universitaire, Innovative therapy for immune disorders, Créteil, France.
Cédric UsureauLaboratoire d'Immunologie et Histocompatibilité, Hôpital Saint Louis, Paris, France.
Emmanuelle BoutinUniversite Paris Est Creteil, INSERM IMRB U955, Créteil, France.
Anna BoueilhDepartment of Nephrology and Renal Transplantation, Assistance Publique-Hôpitaux de Paris, Groupe hospitalo-universitaire Chenevier Mondor, Fédération Hospitalo-Universitaire, Innovative therapy for immune disorders, Créteil, France.
Jean-Luc TaupinINSERM UMR976, Institut de Recherche Saint-Louis, Université de Paris-Cité, Paris, France.
Allan ThiolatUniversite Paris Est Creteil, INSERM IMRB U955, Créteil, France.
José L CohenUniversite Paris Est Creteil, INSERM IMRB U955, Créteil, France.
Vissal David KheavINSERM UMR976, Institut de Recherche Saint-Louis, Université de Paris-Cité, Paris, France.
Florence Canoui-PoitrineUniversite Paris Est Creteil, INSERM IMRB U955, Créteil, France.
Maryvonnick CarmagnatINSERM UMR976, Institut de Recherche Saint-Louis, Université de Paris-Cité, Paris, France.
Philippe GrimbertUniversite Paris Est Creteil, INSERM IMRB U955, Créteil, France.
Marie MatignonUniversite Paris Est Creteil, INSERM IMRB U955, Créteil, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: The safety and benefit of the anti-CD38 monoclonal antibody daratumumab, which induces lysis of antibody-producing plasma cells in sensitized patients prior to kidney transplantation, remain to be determined. Methods: A 2-phase (1 and 2), monocentric open-label study was conducted to evaluate the month 6 (M6) safety and efficacy of daratumumab in kidney transplant candidates with calculated panel reactive antibody (cPRA) > 95%. In the first (safety) phase, we used 4-weekly escalating doses of daratumumab. Phase 2 tested desensitization with 8 weekly infusions of 16 mg/kg daratumumab. cPRA 10,000 was calculated considering only human leukocyte antigen (HLA) antibodies with mean fluorescence intensity (MFI) of > 10,000. Results: Nine patients were enrolled in phase 1 and 14 in phase 2. Safety analysis showed 4 serious non-treatment-emergent adverse events (non-TEAEs), 36 mild TEAEs, mostly infusion-related reactions, grade 1 and 2 (causing 2 temporary drug discontinuations), but no serious TEAEs. Significant reductions in anti-HLA antibodies were observed at month 3 (M3), with cPRA 10,000 ( Conclusion: The first use of daratumumab in desensitization demonstrated infusion-related adverse (AEs) events and rapid, albeit transient, reductions in anti-HLA antibodies, with less than 40% of durable responders, limiting its potential clinical use.

Indexed as

lymphocytespharmacokineticstranslationaltransplantation

Identifiers

PMID39534185
PMCPMC11551132

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Registered trials

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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.