Evidence map›Paper›PMID 37822449›Full record

ArticleTransplant international : official journal of the European Society for Organ Transplantation2023

Qualifying a Novel Clinical Trial Endpoint (iBOX) Predictive of Long-Term Kidney Transplant Outcomes.

Amanda Klein, Alexandre Loupy, Mark Stegall, Ilkka Helanterä, Luke Kosinski, Eric Frey, Olivier Aubert, Gillian Divard, Kenneth Newell, Herwig-Ulf Meier-Kriesche and 7 more

Open access · goldAbstract read
In one paragraph

Article in Transplant international : official journal of the European Society for Organ Transplantation, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
3.3field-weighted citation impact, top 7% 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

8 citing papers in PubMed, 13 citations in OpenAlex.

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  8. Embracing the Wisdom of Ancient Greece in the Era of Personalized Medicine-Uncertainty, Probabilistic Reasoning, and Democratic Consensus.Transplant international : official journal of the European Society for Organ 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

17 authors at 7 institutions in 4 countries.

Amanda KleinCritical Path Institute, Tucson, AZ, United States.
Alexandre LoupyInstitut National de la Santé et de la Recherche Médicale (INSERM), Paris, France.
Mark StegallDepartment of Surgery, Mayo Clinic, Rochester, Rochester, MN, United States.
Ilkka HelanteräDepartment of Transplantation and Liver Surgery, Helsinki University Central Hospital, Helsinki, Finland.
Luke KosinskiCritical Path Institute, Tucson, AZ, United States.
Eric FreyCritical Path Institute, Tucson, AZ, United States.
Olivier AubertInstitut National de la Santé et de la Recherche Médicale (INSERM), Paris, France.
Gillian DivardInstitut National de la Santé et de la Recherche Médicale (INSERM), Paris, France.
Kenneth NewellDivision of Transplantation, Department of Surgery, Emory University School of Medicine, Atlanta, GA, United States.
Herwig-Ulf Meier-KriescheVeloxis Pharmaceuticals, Cary, NC, United States.
Roslyn MannonDivision of Nephrology, Department of Internal Medicine, College of Medicine, University of Nebraska Medical Center, Omaha, NE, United States.
Thomas DumortierPharmacometrics, Novartis, Basel, Switzerland.
Varun AggarwalCritical Path Institute, Tucson, AZ, United States.
Jagdeep T PodichettyCritical Path Institute, Tucson, AZ, United States.
Inish O'DohertyCritical Path Institute, Tucson, AZ, United States.
Ahmed Osama GaberDepartment of Surgery, Houston Methodist Hospital, Houston, TX, United States.
William E FitzsimmonsCritical Path Institute, Tucson, AZ, United States.
Critical Path Institute · USInserm · FRAmerican Society of Transplantation · USDivision of Chemistry · USHelsinki University Hospital · FIMethodist Hospital · USNovartis (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

New immunosuppressive therapies that improve long-term graft survival are needed in kidney transplant. Critical Path Institute's Transplant Therapeutics Consortium received a qualification opinion for the iBOX Scoring System as a novel secondary efficacy endpoint for kidney transplant clinical trials through European Medicines Agency's qualification of novel methodologies for drug development. This is the first qualified endpoint for any transplant indication and is now available for use in kidney transplant clinical trials. Although the current efficacy failure endpoint has typically shown the noninferiority of therapeutic regimens, the iBOX Scoring System can be used to demonstrate the superiority of a new immunosuppressive therapy compared to the standard of care from 6 months to 24 months posttransplant in pivotal or exploratory drug therapeutic studies.

Indexed as

Kidney TransplantationGraft RejectionHumansImmunosuppression TherapyImmunosuppressive AgentsImmunosuppressive AgentsiBoxkidney transplantorgan transplanttransplant clinical trialtransplant outcomes

Identifiers

PMID37822449
PMCPMC10563802
OpenAlexW4387023134

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.