Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT05497518
Status:
RECRUITING
Last Update Posted:
2025-05-13
First Post:
2022-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The KidneyCARE (Community Access to Research Equity) Study
Sponsor:
Tufts Medical Center
Organization:
Study Overview
Official Title:
The KidneyCARE (Community Access to Research Equity) Study: A National Registry for People With All Stages of Kidney Disease (Formerly National Kidney Foundation Patient Network)
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
For chronic kidney disease (CKD), there is a lack of unique and powerful platform for patient engagement, research studies and public health advocacy work. The National kidney Foundation (NKF) launched the first nationwide registry for people at all stages and types of CKD, including people on dialysis and kidney transplant recipients, called the KidneyCARE Study (kidneycarestudy.org). The KidneyCARE Study is a non-interventional research study which means participants will not have to take medications or do any additional tests to participate. They are simply asked to share some personal and health information, and their experiences with their disease through a secure portal. The Study also collaborates with health systems to obtain additional electronic health records (EHR) data. This unique combination of data collected will address the gap of individualized educational resources and will enhance clinical research, clinical care, and health policy decisions to be centered on the patient. The Study is all online and can be accessed any time of day at kidneycarestudy.org. Participation is voluntary and free.
Detailed Description:
The KidneyCARE Study is a longitudinal prospective and retrospective observational cohort study of patient-entered data that collaborates with health systems to obtain additional electronic health records (EHR) data. The Study is approved by the Tufts Health Sciences Institutional Review Board, which serves as the IRB of record for all U.S. sites. The Study will start patient recruitment outside of the U.S. in 2022. The first international country will be Canada. The University of Manitoba, Winnipeg, MB, Canada is the Coordinating Site for all Canadian sites.
De-identified aggregate data is available for analysis to the NKF and the partners of the Study via analytic portals, dashboards, and/or subscription reports depending on contractual agreements. The individual site's data will be segregated from the rest of the registry, but the de-identified aggregate data can still be included in the overall registry's dashboard, reports, and analytics. Research proposals by partners and outside investigators that require advanced statistical analysis for publications in peer-reviewed journals, abstracts, and/or posters must be submitted and approved according to the Data Use and Publications policy. The Data Coordinating Center (DCC) conducts the statistical analyses for all approved research proposals.
De-identified aggregate data is available for analysis to the NKF and the partners of the Study via analytic portals, dashboards, and/or subscription reports depending on contractual agreements. The individual site's data will be segregated from the rest of the registry, but the de-identified aggregate data can still be included in the overall registry's dashboard, reports, and analytics. Research proposals by partners and outside investigators that require advanced statistical analysis for publications in peer-reviewed journals, abstracts, and/or posters must be submitted and approved according to the Data Use and Publications policy. The Data Coordinating Center (DCC) conducts the statistical analyses for all approved research proposals.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: