The KidneyCARE (Community Access to Research Equity) Study

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease; Dialysis; Kidney Transplant
• Intervention / Treatment: Other: Observational study - registry

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.

• Study Type: Observational
• Enrollment (Estimated): 50000

Contacts and Locations

• Study Contact: Name: Lesley A Inker, MD, MS; Phone Number: 617-636-2569; Email: LInker@Tuftsmedicalcenter.org
• Study Contact Backup: Name: Kerry Willis, PhD; Phone Number: 212-889-2210; Email: kwillis@kidney.org

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Recruiting
      • Geisinger Clinic
      • Contact: Alexander Chang, MD, MS; Phone Number: option 4 866-207-9289; Email: achang@geisinger.edu
      • Principal Investigator: Alexander Chang, MD, MS
      • Contact: Lauren Brubaker, MPH; Phone Number: 570-271-6393; Email: labrubaker@geisinger.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

People with chronic kidney disease; No interventions will be administered as part of this registry.

Other: Observational study - registry; The Study is a longitudinal observational cohort study that collaborates with health systems to obtain both electronic healthcare records (EHR) and patient-entered data. Eligible people with a diagnosis of chronic kidney disease at any stage, age 18 years and above, are identified through EHR data review, referral by a provider, or are recruited through the NKF's outreach campaign. Patients self-enroll into the online registry and share their experiences and health data through a secure portal where they can also find education, tips, and support. Research partners can view aggregate data through a collaboration portal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of enrolled participants	Reach 10,000 enrolled participants	5 years

Collaborators and Investigators

• Sponsor: Tufts Medical Center
• Collaborators: National Kidney Foundation
• Investigators: Study Director: Kerry Willis, PhD, National Kidney Foudnation

Publications and helpful links

General Publications

• 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.

Helpful Links

• Link for joining the first nationwide registry for people at all stages and types of kidney disease to transform kidney care and research together.

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2021
• Primary Completion (Estimated): February 24, 2070
• Study Completion (Estimated): February 24, 2070

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Chronic kidney disease; Dialysis; Kidney transplant; Patient registry; Hereditary nephropathy; Genetic kidney disease; Rare kidney disease
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: STUDY00000053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No