Guinsburg, Adrián M.
Jiao, Yue
Bessone, María Inés Díaz
Monaghan, Caitlin K.
Magalhães, Beatriz
Kraus, Michael A.
Kotanko, Peter
Hymes, Jeffrey L.
Kossmann, Robert J.
Berbessi, Juan Carlos
Maddux, Franklin W.
Usvyat, Len A.
Larkin, John W.
Funding for this research was provided by:
Fresenius Medical Care
Article History
Received: 24 February 2022
Accepted: 4 October 2022
First Online: 22 October 2022
Declarations
:
: All experimental protocols were approved by a named institutional entity and/or licensing committee (Fresenius Medical Care and New England Independent Review Board). In LatAm and North America, de-identified data was used for the purposes of the parallel analyses. The EuCLiD database was used for capturing data in the Latin America cohort as part of Fresenius Medical Care's quality improvement and management programs in all NephroCare clinics utilizing EuCLiD [CitationRef removed]. EuCLiD governance has established protocols and procedures for use of clinical data from NephroCare clinics for secondary research purposes, and granted approval for the extraction of data for this secondary analysis in the Latin America cohort. Data was only collected from patients who provided informed consent for their data to be collected into EuCliD and the data was de-identified by the LatAm investigator. The Fresenius Medical Care North America Knowledge Center Data Warehouse was used for capturing data in the North America cohort from clinics in the Fresenius Kidney Care network. In North America, data was collected from patients treated in the United States under a protocol approved by New England Independent Review Board (NEIRB; Needham Heights, MA, United States); NEIRB determined the analysis of the North America cohort was exempt due to use of data de-identified by the North America investigator that no longer contained protected health information and consent was not required per title 45 of the United States Code of Federal Regulations part 46.104(d)(4) (NEIRB# 1–1439054-1). The analysis in each region was conducted in accordance with the Declaration of Helsinki.
: Not applicable.
: All authors are employees of Fresenius Medical Care, or its wholly owned subsidiary Renal Research Institute. J.H., L.A.U., P.K., F.W.M. have share options/ownership in Fresenius Medical Care. P.K. receives honorarium from Up-To-Date and is on the Editorial Board of Blood Purification and Kidney and Blood Pressure Research. C.K.M., J.H., J.W.L., L.A.U., P.K., F.W.M. are an inventor on patent(s) in the field of dialysis. J.W.L. is a guest editor on the Editorial Board of Frontiers in Physiology. F.W.M. has directorships in Fresenius Medical Care Management Board, Goldfinch Bio, and Vifor Fresenius Medical Care Renal Pharma.