Evidence map›Paper›PMID 28758341›Full record

Trial reportAmerican journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons2017

Ten-year outcomes in a randomized phase II study of kidney transplant recipients administered belatacept 4-weekly or 8-weekly.

F Vincenti, G Blancho, A Durrbach, G Grannas, J Grinyó, H-U Meier-Kriesche, M Polinsky, L Yang, C P Larsen

Open access · hybridAbstract readClinical Trial, Phase IIRandomized 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, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
2.9field-weighted citation impact, top 10% 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

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 citations in OpenAlex.

  1. Pooled it
  2. 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
  3. Challenges of calcineurin inhibitor withdrawal following combined pancreas and kidney transplantation: Results of a prospective, randomized clinical trial.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2020
    Trial
  4. Ten-year outcomes in a randomized phase II study of kidney transplant recipients administered belatacept 4-weekly or 8-weekly.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2017
    Trial
  5. Review
  6. Review
  7. Article
  8. Review
  9. Review
  10. Article
  11. Article
  12. Surrogate Endpoints for Late Kidney Transplantation Failure.Transplant international : official journal of the European Society for Organ Transplantation · 2022
    Article
  13. Rationale for Surrogate Endpoints and Conditional Marketing Authorization of New Therapies for Kidney Transplantation.Transplant international : official journal of the European Society for Organ Transplantation · 2022
    Review
  14. Article
  15. Article
  16. Review
  17. Article
  18. Review
  19. CTLA4Ig Improves Murine iTreg Induction via TGFJournal of immunology research · 2018
    Article
  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

9 authors at 7 institutions in 4 countries.

F VincentiUniversity of California, San Francisco, San Francisco, CA, USA.
G BlanchoUniversity Hospital of Nantes, Nantes, France.
A DurrbachUniversity Hôpital of Bicêtre, Le Kremlin-Bicêtre, France.
G GrannasMedizinische Hochschule Hannover, Hannover, Germany.
J GrinyóUniversity Hospital of Bellvitge, Barcelona, Spain.
H-U Meier-KriescheBristol-Myers Squibb, Lawrenceville, NJ, USA.
M PolinskyBristol-Myers Squibb, Lawrenceville, NJ, USA.
L YangBristol-Myers Squibb, Lawrenceville, NJ, USA.
C P LarsenEmory University Transplant Center, Atlanta, GA, USA.
Bristol-Myers Squibb (United States) · USBellvitge University Hospital · ESBicêtre Hospital · FRCentre Hospitalier Universitaire de Nantes · FREmory University · USMedizinische Hochschule Hannover · DEUniversity of California, San Francisco · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In the phase II IM103-100 study, kidney transplant recipients were first randomized to belatacept more-intensive-based (n = 74), belatacept less-intensive-based (n = 71), or cyclosporine-based (n = 73) immunosuppression. At 3-6 months posttransplant, belatacept-treated patients were re-randomized to receive belatacept every 4 weeks (4-weekly, n = 62) or every 8 weeks (8-weekly, n = 60). Patients initially randomized to cyclosporine continued to receive cyclosporine-based immunosuppression. Cumulative rates of biopsy-proven acute rejection (BPAR) from first randomization to year 10 were 22.8%, 37.0%, and 25.8% for belatacept more-intensive, belatacept less-intensive, and cyclosporine, respectively (belatacept more-intensive vs cyclosporine: hazard ratio [HR] = 0.95; 95% confidence interval [CI] 0.47-1.92; P = .89; belatacept less-intensive vs cyclosporine: HR = 1.61; 95% CI 0.85-3.05; P = .15). Cumulative BPAR rates from second randomization to year 10 for belatacept 4-weekly, belatacept 8-weekly, and cyclosporine were 11.1%, 21.9%, and 13.9%, respectively (belatacept 4-weekly vs cyclosporine: HR = 1.06, 95% CI 0.35-3.17, P = .92; belatacept 8-weekly vs cyclosporine: HR = 2.00, 95% CI 0.75-5.35, P = .17). Renal function trends were estimated using a repeated-measures model. Estimated mean GFR values at year 10 for belatacept 4-weekly, belatacept 8-weekly, and cyclosporine were 67.0, 68.7, and 42.7 mL/min per 1.73 m

Indexed as

AbataceptFollow-Up StudiesGlomerular Filtration RateGraft RejectionGraft SurvivalHumansImmunosuppressive AgentsKidney Failure, ChronicKidney Function TestsKidney TransplantationPostoperative ComplicationsPrognosisRisk FactorsSurvival RateAbataceptImmunosuppressive Agentsclinical research/practiceclinical trialglomerular filtration rate (GFR)immunosuppressant - fusion proteins and monoclonal antibodies: belataceptkidney (allograft) function/dysfunctionkidney transplantation: living donorkidney transplantation/nephrology

Identifiers

PMID28758341
PMCPMC5724691
OpenAlexW2741321168

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.