Evidence map›Paper›PMID 31397943›Full record

Trial reportAmerican journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons2020

A randomized, phase 1b study of the pharmacokinetics, pharmacodynamics, safety, and tolerability of bleselumab, a fully human, anti-CD40 monoclonal antibody, in kidney transplantation.

Flavio Vincenti, Goran Klintmalm, Harold Yang, V Ram Peddi, Paul Blahunka, Angela Conkle, Vicki Santos, John Holman

Open access · hybridAbstract readClinical Trial, Phase IMulticenter 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, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 8% 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

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. A randomized, phase 1b study of the pharmacokinetics, pharmacodynamics, safety, and tolerability of bleselumab, a fully human, anti-CD40 monoclonal antibody, in kidney transplantation.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2020
    Trial
  4. Article
  5. Article
  6. Review
  7. Review
  8. Review
  9. Article
  10. FcγRs and Their Relevance for the Activity of Anti-CD40 Antibodies.International journal of molecular sciences · 2022
    Review
  11. CD40-CD40L in Neurological Disease.International journal of molecular sciences · 2022
    Review
  12. Review
  13. Review
  14. Review
  15. Review
  16. Article
  17. Review
  18. Review
  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

8 authors at 4 institutions in 1 country.

Flavio VincentiDepartment of Medicine and Surgery, University of California San Francisco, San Francisco, California.
Goran KlintmalmDepartment of Transplantation Services, Annette C. and Harold C. Simmons Transplant Institute, Dallas, Texas.
Harold YangDepartment of Surgery, Pinnacle Health Transplant Associates, Harrisburg, Pennsylvania.
V Ram PeddiDepartment of Transplantation, California Pacific Medical Center, San Francisco, California.
Paul BlahunkaAstellas Pharma Global Development, Inc., Northbrook, Illinois.
Angela ConkleAstellas Pharma Global Development, Inc., Northbrook, Illinois.
Vicki SantosAstellas Pharma Global Development, Inc., Northbrook, Illinois.
John HolmanAstellas Pharma Global Development, Inc., Northbrook, Illinois.
Astellas Pharma (United States) · USCalifornia Pacific Medical Center · USUniversity of California, San Francisco · USUPMC Central Pa · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of various doses of the anti-CD40 monoclonal antibody bleselumab (ASKP1240) in de novo kidney transplant recipients receiving concomitant standard immunosuppression over 90 days posttransplant. Transplant recipients were randomized (1:1:1:1:1) to bleselumab 50 mg, 100 mg, 200 mg, or 500 mg, or placebo, in addition to standard maintenance immunosuppression. The primary pharmacokinetic endpoints were AUC

Indexed as

AdultAntibodies, Monoclonal, HumanizedCD40 AntigensDouble-Blind MethodFemaleFollow-Up StudiesGraft RejectionGraft SurvivalHumansImmune ToleranceImmunosuppressive AgentsKidney Failure, ChronicKidney TransplantationMaleMaximum Tolerated DoseMiddle AgedAntibodies, Monoclonal, HumanizedbleselumabCD40 AntigensImmunosuppressive Agentsantibody biologyclinical research/practicekidney transplantation: living donorkidney transplantation/nephrology

Identifiers

PMID31397943
PMCPMC6972670
OpenAlexW2967768293

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.