학술논문
Prospective observational study to validate a next-generation sequencing blood RNA signature to predict early kidney transplant rejection.
Document Type
Academic Journal
Author
Bestard O; Hospital Universitari Vall d'Hebron, Barcelona, Spain.; Augustine J; Cleveland Clinic, Cleveland, Ohio, USA.; Wee A; Cleveland Clinic, Cleveland, Ohio, USA.; Poggio E; Cleveland Clinic, Cleveland, Ohio, USA.; Mannon RB; University of Nebraska Medical Center, Omaha, Nebraska, USA.; Ansari MJ; Northwestern University, Evanston, Illinois, USA.; Bhati C; University of Maryland, Baltimore, Maryland, USA.; Maluf D; University of Maryland, Baltimore, Maryland, USA.; Benken S; University of Illinois at Chicago, Chicago, Illinois, USA.; Leca N; University of Washington, Seattle, Washington, USA.; La Manna G; Nephrology, Dialysis and Kidney Transplant Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy.; Samaniego-Picota M; Henry Ford Health System, Detroit, Michigan, USA.; Shawar S; Vanderbilt University, Nashville, Tennessee, USA.; Concepcion BP; University of Chicago, Chicago, Illinois, USA.; Rostaing L; CHU Grenoble Alpes, Grenoble, France.; Alberici F; ASST degli Spedali Civili di Brescia, Brescia, Italy.; O'Connell P; Westmead Institute, Sydney, Australia.; Chang A; University of Chicago, Chicago, Illinois, USA.; Salem F; Mayo Medical, Jacksonville, Florida, USA.; Kattan MW; Cleveland Clinic, Cleveland, Ohio, USA.; Gallon L; Northwestern University, Evanston, Illinois, USA; Verici Dx, Franklin, Tennessee, USA. Electronic address: l-gallon@northwestern.edu.; Donovan MJ; Verici Dx, Franklin, Tennessee, USA; Icahn School of Medicine at Mount Sinai, New York, New York, USA. Electronic address: mdonovan@vericidx.com.
Source
Publisher: Elsevier Country of Publication: United States NLM ID: 100968638 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1600-6143 (Electronic) Linking ISSN: 16006135 NLM ISO Abbreviation: Am J Transplant Subsets: MEDLINE
Subject
Language
English
Abstract
The objective of this study was to validate the performance of Tutivia, a peripheral blood gene expression signature, in predicting early acute rejection (AR) post-kidney transplant. Recipients of living or deceased donor kidney transplants were enrolled in a nonrandomized, prospective, global, and observational study (NCT04727788). The main outcome was validation of the area under the curve (AUC) of Tutivia vs serum creatinine at biopsy alone, or Tutivia + serum creatinine at biopsy. Of the 151 kidney transplant recipients, the mean cohort age was 53 years old, and 64% were male. There were 71% (107/151) surveillance/protocol biopsies and 29% (44/151) for-cause biopsies, with a 31% (47/151) overall rejection rate. Tutivia (AUC 0.69 [95% CI: 0.59-0.77]) and AUC of Tutivia + creatinine at biopsy (0.68 [95% CI: 0.59-0.77]) were greater than the AUC of creatinine at biopsy alone (0.51.4 [95% CI: 0.43-0.60]). Applying a model cut-off of 50 (scale 0-100) generated a high- and low-risk category for AR with a negative predictive value of 0.79 (95% CI: 0.71-0.86), a positive predictive value of 0.60 (95% CI: 0.45-0.74), and an odds ratio of 5.74 (95% CI: 2.63-12.54). Tutivia represents a validated noninvasive approach for clinicians to accurately predict early AR, beyond the current standard of care.
(Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)
(Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)