Clinical trial NCT05497518: The KidneyCARE (Community Access to Research Equity) Study
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Disease
Dialysis
Kidney Transplant
Keywords: Chronic kidney disease
Dialysis
Kidney transplant
Patient registry
Hereditary nephropathy
Genetic kidney disease
Rare kidney disease
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: National Kidney Foundation, United States
First posted: 2022-08-11
Enrollment: 50000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient recruitment targets two audiences: general public and closed systems. The general public is reached through a comprehensive outreach program that includes other NKF programs, local NKF field offices, participants from clinical trials for kidney disease treatments, referrals from other Network's participants, professional societies and patient advocacy groups, and a direct public relations campaign. The closed systems include health systems, academic medical centers, testing laboratories, or rare kidney disease groups. Here, patients will be recruited using the methods available at each organization (e.g., e-blasts, newsletters, provider/care manager recommendation, MyChart messages).

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.

Eligibility criteria: Inclusion Criteria:

* Patients with any stage of CKD, including kidney transplant recipients and patients on dialysis.
* Age 18 years and above.
* Willing to participate in the Study and complete the informed consent form and assent form (where applicable).
* Able to participate in this Study, which initially will be in English and then eventually expand to other languages.
* Patients affiliated with Geisinger Health System must have given their consent to Geisinger Health System IRB to be contacted for research projects.

Exclusion Criteria:

* Patient not diagnosed with CKD
* Age below 18 years
* Not willing to participate in the Study as well as unwilling to complete the informed consent form

Primary outcomes:
measure: Total number of enrolled participants
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Clinic
state: Pennsylvania
Study officials:
affiliation: National Kidney Foudnation
name: Kerry Willis, PhD
role: STUDY_DIRECTOR
References:
citation: Inker LA, Ferre S, Baliker M, Barr A, Bonebrake L, Chang AR, Chaudhari J, Cooper K, Diamantidis CJ, Forfang D, Gillespie B, Gregoriou P, Gwadry-Sridhar F, Ladin K, Maxwell C, Mitchell KR, Murphy KP, Rakibuz-Zaman M, Rocco MV, Spry LA, Sharma A, Tangri N, Warfield C, Willis K; NKF Patient Network Governance Committees. A National Registry for People With All Stages of Kidney Disease: The National Kidney Foundation (NKF) Patient Network. Am J Kidney Dis. 2023 Feb;81(2):210-221.e1. doi: 10.1053/j.ajkd.2022.07.016. Epub 2022 Sep 30.