Evidence map›Paper›PMID 29189482›Full record

Observational studyTransplantation2018

Analysis of Biomarkers Within the Initial 2 Years Posttransplant and 5-Year Kidney Transplant Outcomes: Results From Clinical Trials in Organ Transplantation-17.

Geovani Faddoul, Girish N Nadkarni, Nancy D Bridges, Jens Goebel, Donald E Hricik, Richard Formica, Madhav C Menon, Yvonne Morrison, Barbara Murphy, Kenneth Newell and 5 more

Registry-linked trialAbstract readComparative StudyMulticenter StudyObservational Study
In one paragraph

Observational study in Transplantation, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01974999 (A Retrospective Multicenter Study to Determine 5-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-01 Study), which is not on this map. Cited by 31 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 1 pooled it
–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.

NCT01974999 completednot on this map

A Retrospective Multicenter Study to Determine 5-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-01 Study (CTOT-17)

TypeobservationalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2013 to 2014Enrolled184ConditionsKidney Disease, Kidney Failure, End Stage Renal Disease
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Genome-wide donor-recipient non-HLA mismatch and graft loss.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2025
    Pooled it
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Utility of the Interferon-Gamma Enzyme-Linked Immunosorbent Spot Assay to Predict Risk of Cytomegalovirus Infection in Kidney Transplant Recipients.Transplant international : official journal of the European Society for Organ Transplantation · 2023
    Article
  12. Review
  13. Article
  14. Donor Derived Cell Free DNA in Kidney Transplantation: The Circa 2020-2021 Update.Transplant international : official journal of the European Society for Organ Transplantation · 2022
    Review
  15. Allograft Function as Endpoint for Clinical Trials in Kidney Transplantation.Transplant international : official journal of the European Society for Organ Transplantation · 2022
    Article
  16. Article
  17. Review
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors.

Geovani FaddoulDepartment of Medicine, Translational Transplant Research Center, Recanati Miller Transplant Institute, Immunology Institute Icahn School of Medicine at Mount Sinai, New York, NY.
Girish N NadkarniDepartment of Medicine, Translational Transplant Research Center, Recanati Miller Transplant Institute, Immunology Institute Icahn School of Medicine at Mount Sinai, New York, NY.
Nancy D BridgesNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD.
Jens GoebelDepartment of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.
Donald E HricikDepartment of Medicine, University Hospitals Case Medical Center, Cleveland, OH.
Richard FormicaDepartment of Medicine, Yale University School of Medicine, New Haven, CT.
Madhav C MenonDepartment of Medicine, Translational Transplant Research Center, Recanati Miller Transplant Institute, Immunology Institute Icahn School of Medicine at Mount Sinai, New York, NY.
Yvonne MorrisonNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD.
Barbara MurphyDepartment of Medicine, Translational Transplant Research Center, Recanati Miller Transplant Institute, Immunology Institute Icahn School of Medicine at Mount Sinai, New York, NY.
Kenneth NewellDepartment of Surgery, Emory University Medical Center, Atlanta, GA.
Peter NickersonDepartment of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.
Emilio D PoggioDepartment of Nephrology and Hypertension, Cleveland Clinic, Cleveland, OH.
David RushDepartment of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.
Peter S HeegerDepartment of Medicine, Translational Transplant Research Center, Recanati Miller Transplant Institute, Immunology Institute Icahn School of Medicine at Mount Sinai, New York, NY.
CTOT-17 consortium

Funding

Noninvasive Markers and Transplant Outcome in HumansU01AI063594 · NIAID · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI HEEGER, PETER SCOTT · 2004 to 2022
$66.5M
Risk Clustering and Stratification in Genetically High-Risk Individuals Using Electronic Medical Records and BiomarkersK23DK107908 · NIDDK · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI NADKARNI, GIRISH NITIN · 2016 to 2020
$930k
NIAID NIH HHS U01 AI063594NIDDK NIH HHS K23 DK107908
6 · The paper itself

Abstract

backgroundAn early posttransplant biomarker/surrogate marker for kidney allograft loss has the potential to guide targeted interventions. Previously published findings, including results from the Clinical Trials in Organ Transplantation (CTOT)-01 study, showed that elevated urinary chemokine CXCL9 levels and elevated frequencies of donor-reactive interferon gamma (IFNγ)-producing T cells by enzyme-linked immunosorbent spot (ELISPOT) assay associated with acute cellular rejection within the first year and with lower 1-year posttransplant estimated glomerular filtration rate (eGFR). How well these biomarkers correlate with late outcomes, including graft loss, is unclear.

methodsIn CTOT-17, we obtained 5-year outcomes in the CTOT-01 cohort and correlated them with (a) biomarker results and (b) changes in eGFR (Chronic Kidney Disease Epidemiology Collaboration formula) over the initial 2 years posttransplant using univariable analysis and multivariable logistic regression.

resultsGraft loss occurred in 14 (7.6%) of 184 subjects 2 to 5 years posttransplant. Neither IFNγ ELISPOTs nor urinary CXCL9 were informative. In contrast, a 40% or greater decline in eGFR from 6 months to 2 years posttransplant independently correlated with 13-fold odds of 5-year graft loss (adjusted odds ratio, 13.1; 95% confidence interval, 3.0-56.6), a result that was validated in the independent Genomics of Chronic Allograft Rejection cohort (n = 165; adjusted odds ratio, 11.2).

conclusionsWe conclude that although pretransplant and early posttransplant ELISPOT and chemokine measurements associate with outcomes within 2 years posttransplant, changes in eGFR between 3 or 6 months and 24 months are better surrogates for 5-year outcomes, including graft loss.

Indexed as

Glomerular Filtration RateAdultAgedBiomarkersChemokine CXCL9Enzyme-Linked Immunospot AssayFemaleGraft RejectionGraft SurvivalHumansInterferon-gammaInterferon-gamma Release TestsKidneyKidney TransplantationMaleMiddle AgedBiomarkersChemokine CXCL9CXCL9 protein, humanIFNG protein, humanInterferon-gamma

Identifiers

PMID29189482
PMCPMC6018026

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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.