Chronic Kidney DiseaseNCT05497518
The KidneyCARE (Community Access to Research Equity) Study
An observational study of Chronic Kidney Disease and Dialysis, run by Tufts Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Chronic Kidney Disease, Dialysis, Kidney Transplant
- What is being tested?
- Observational study - registry
- How many people
- 50,000 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2021to 24 Feb 2070
- How long will I take part?
- 50 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Geisinger Clinic
Danville, Pennsylvania, 17822
Alexander Chang, MD, MS, 866-207-9289 ext. option 4, achang@geisinger.edu
Lauren Brubaker, MPH, 570-271-6393, labrubaker@geisinger.edu
About this 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)
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.
Read the 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.
- Conditions
- Chronic Kidney Disease, Dialysis, Kidney Transplant
- Being tested
- Observational study - registry
- Keywords
- Chronic kidney disease, Dialysis, Kidney transplant, Patient registry, Hereditary nephropathy, Genetic kidney disease, Rare kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study - registryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| People with chronic kidney disease | No interventions will be administered as part of this registry. Receives: Other: Observational study - registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of enrolled participants
Reach 10,000 enrolled participants
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start25 Feb 2021
- Primary completion24 Feb 2070 (estimated)
- Study completion24 Feb 2070 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50,000 participants (estimated)
- Target duration
- 50 Years
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Kidney Foundation, United States
- Responsible party
- Sponsor
- Investigators
- Kerry Willis, PhD, Study director, National Kidney Foudnation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497518
- Sponsor's protocol ID
- STUDY00000053
- Status last verified
- Oct 2026
- First submitted
- 9 Aug 2022
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36191726
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05497518
- Acronym / sponsor ID
- STUDY00000053
- Conditions
- Chronic Kidney Disease, Dialysis, Kidney Transplant
- Keywords
- Chronic kidney disease, Dialysis, Kidney transplant, Patient registry, Hereditary nephropathy, Genetic kidney disease, Rare kidney disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- National Kidney Foundation, United States
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 24 Feb 2070 (estimated)
- Study completion
- 24 Feb 2070 (estimated)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 50 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with chronic kidney disease | – | Other: Observational study - registryNo interventions will be administered as part of this registry. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study - registryThe 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. | Other | People with chronic kidney disease |
Primary outcome
Total number of enrolled participants
Time frame: 5 years
Reach 10,000 enrolled participants
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 36191726Inker 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.
- Link for joining the first nationwide registry for people at all stages and types of kidney disease to transform kidney care and research together.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kerry Willis, PhD study director
National Kidney Foudnation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease and Dialysis, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lesley A Inker, MD, MS (617-636-2569, LInker@Tuftsmedicalcenter.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of enrolled participants (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05497518, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.