- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05497518
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)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The NKF Patient Network 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 NKF Patient Network is approved by the Tufts Health Sciences Institutional Review Board, which serves as the IRB of record for all U.S. sites. The NKF Patient Network 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 NKF Patient Network 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
Enrollment (Estimated)
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
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Pennsylvania
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Danville, Pennsylvania, United States, 17822
- Geisinger Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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 NKF Patient Network and complete the informed consent form and assent form (where applicable).
- Able to participate in this NKF Patient Network, 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 NKF Patient Network as well as unwilling to complete the informed consent form
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
People with chronic kidney disease
No interventions will be administered as part of this registry.
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The Network 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total number of enrolled participants
Time Frame: 5 years
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Reach 10,000 enrolled participants
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5 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Kerry Willis, PhD, National Kidney Foudnation
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-500-1060
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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