Evidence map›Paper›PMID 26816011›Full record

Trial reportThe New England journal of medicine2016

Belatacept and Long-Term Outcomes in Kidney Transplantation.

Flavio Vincenti, Lionel Rostaing, Joseph Grinyo, Kim Rice, Steven Steinberg, Luis Gaite, Marie-Christine Moal, Guillermo A Mondragon-Ramirez, Jatin Kothari, Martin S Polinsky and 3 more

Erratum issued 4 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 4 registered trials, which are not on this map. Cited by 303 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
303citing papers in PubMed, 4 pooled it
70.0field-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.

NCT00256750 phase3completednot on this map

Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial (BENEFIT)

TypeinterventionalSponsorBristol-Myers SquibbRan2005 to 2015Enrolled738ConditionsKidney Transplantation, Chronic Kidney FailureArmsCyclosporine (CsA), Belatacept LI (less intensive), Belatacept MI (more intensive)
NCT04469842 early_phase1recruitingnot on this mapstarted 2023, after this paper: background citation

A Prospective, Randomized, Controlled Pilot Study of Early-Use Long Acting Tacrolimus (Envarsus XR) in Lung Transplant Recipients

TypeinterventionalSponsorVanderbilt University Medical CenterRan2023 to 2027Enrolled48ConditionsLung Transplant, ComplicationsArmsTacrolimus Extended Release Oral Tablet [Envarsus], Tacrolimus, Mycophenolate Mofetil Hydrochloride, Prednisone, Azathioprine
NCT05145296 phase2terminatednot on this mapstarted 2022, after this paper: background citation

Non-Randomized, Single-Center Pilot Trial Assessing The Safety/Efficacy Of Targeting Peripheral And Central Humoral Alloimmune Memory With Daratumumab And With Belatacept In Highly HLA-Sensitized Patients Awaiting Kidney Transplantation

TypeinterventionalSponsorUniversity Hospital, GrenobleRan2022 to 2025Enrolled5ConditionsSensitisation, Highly Sensitised Dialysis PatientsArmsEach patient will undergo in the first step of the study belatacept treatment and in the second apheresis and daratumumab
NCT05316038 unknown statusnot on this mapstarted 2022, after this paper: background citation

Study of the Impact of Belatacept Conversion on Metabolic and Infectious Complications in Kidney Transplant Recipients at Grenoble-Alpes University Hospital

TypeobservationalSponsorUniversity Hospital, GrenobleRan2022 to 2024Enrolled100ConditionsKidney Transplant Infection, Cardiovascular Diseases, Immunosuppression, Kidney TransplantArmsOral glucose tolerance test
3 · Its place in the literature

Who cites it

303 citing papers in PubMed, 4 syntheses or guidelines pooled it, 743 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Immunosuppression in Older Kidney Transplant Recipients: A Randomized Controlled Trial.Journal of the American Society of Nephrology : JASN · 2026
    Trial
  7. Trial
  8. A pilot randomized controlled trial of de novo belatacept-based immunosuppression following anti-thymocyte globulin induction in lung transplantation.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2022
    Trial
  9. Trial
  10. Every 2-month belatacept maintenance therapy in kidney transplant recipients greater than 1-year posttransplant: A randomized, noninferiority trial.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2021
    Trial
  11. Trial
  12. Avoidance of CNI and steroids using belatacept-Results of the Clinical Trials in Organ Transplantation 16 trial.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2020
    Trial
  13. Trial
  14. Article
  15. Review
  16. Review
  17. De novo belatacept-based immunosuppression is not associated with increased risk of invasive fungal infection in kidney transplant recipients.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2026
    Article
  18. Article
  19. Article
  20. Article

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 11 institutions in 6 countries.

Flavio VincentiFrom the University of California, San Francisco, San Francisco (F.V.), and Sharp Memorial Hospital, San Diego (S.S.) - both in California; University Hospital and INSERM Unité 563, IFR-BMT, Toulouse (L.R.), and Hôpital de La Cavale Blanche, Brest (M.-C.M.) - both in France; University Hospital Bellvitge, Barcelona (J.G.); Baylor University Medical Center, Dallas (K.R.); Clínica de Nefrología, Santa Fe, Argentina (L.G.); Instituto Mexicano de Trasplantes, Morelos, Mexico (G.A.M.-R.); Hinduja Hospital, Hinduja Health Care and Apex Kidney Foundation, Mumbai, India (J.K.); Bristol-Myers Squibb, Princeton, NJ (M.S.P., H.-U.M.-K.); Bristol-Myers Squibb, Braine-l'Alleud, Belgium (S.M.); and Emory University Transplant Center, Atlanta (C.P.L.).
Lionel Rostaing
Joseph Grinyo
Kim Rice
Steven Steinberg
Luis Gaite
Marie-Christine Moal
Guillermo A Mondragon-Ramirez
Jatin Kothari
Martin S Polinsky
Herwig-Ulf Meier-Kriesche
Stephane Munier
Christian P Larsen
Baylor University Medical Center · USBellvitge University Hospital · ESBristol-Myers Squibb (Belgium) · BEBristol-Myers Squibb (United States) · USCentro Científico Tecnológico - Santa Fe · AREmory University · USHôpital Maison Blanche · FRInserm · FRP. D. Hinduja Hospital and Medical Research Centre · INSharp Memorial Hospital · USUniversity of California, San Francisco · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn previous analyses of BENEFIT, a phase 3 study, belatacept-based immunosuppression, as compared with cyclosporine-based immunosuppression, was associated with similar patient and graft survival and significantly improved renal function in kidney-transplant recipients. Here we present the final results from this study.

methodsWe randomly assigned kidney-transplant recipients to a more-intensive belatacept regimen, a less-intensive belatacept regimen, or a cyclosporine regimen. Efficacy and safety outcomes for all patients who underwent randomization and transplantation were analyzed at year 7 (month 84).

resultsA total of 666 participants were randomly assigned to a study group and underwent transplantation. Of the 660 patients who were treated, 153 of the 219 patients treated with the more-intensive belatacept regimen, 163 of the 226 treated with the less-intensive belatacept regimen, and 131 of the 215 treated with the cyclosporine regimen were followed for the full 84-month period; all available data were used in the analysis. A 43% reduction in the risk of death or graft loss was observed for both the more-intensive and the less-intensive belatacept regimens as compared with the cyclosporine regimen (hazard ratio with the more-intensive regimen, 0.57; 95% confidence interval [CI], 0.35 to 0.95; P=0.02; hazard ratio with the less-intensive regimen, 0.57; 95% CI, 0.35 to 0.94; P=0.02), with equal contributions from the lower rates of death and graft loss. The mean estimated glomerular filtration rate (eGFR) increased over the 7-year period with both belatacept regimens but declined with the cyclosporine regimen. The cumulative frequencies of serious adverse events at month 84 were similar across treatment groups.

conclusionsSeven years after transplantation, patient and graft survival and the mean eGFR were significantly higher with belatacept (both the more-intensive regimen and the less-intensive regimen) than with cyclosporine. (Funded by Bristol-Myers Squibb; ClinicalTrials.gov number, NCT00256750.).

Indexed as

Graft SurvivalKidney TransplantationAbataceptCyclosporineFollow-Up StudiesGlomerular Filtration RateHumansImmunosuppressive AgentsIntention to Treat AnalysisKaplan-Meier EstimateKidney Failure, ChronicSingle-Blind MethodAbataceptCyclosporineImmunosuppressive Agents

Identifiers

PMID26816011
OpenAlexW2317185835

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.