NCT05497518

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50,000

participants targeted

Target at P75+ for all trials

Timeline
534mo left

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Feb 2021Feb 2070

Study Start

First participant enrolled

February 25, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
47.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2070

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2070

Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

49 years

First QC Date

August 9, 2022

Last Update Submit

May 7, 2025

Conditions

Keywords

Chronic kidney diseaseDialysisKidney transplantPatient registryHereditary nephropathyGenetic kidney diseaseRare kidney disease

Outcome Measures

Primary Outcomes (1)

  • Total number of enrolled participants

    Reach 10,000 enrolled participants

    5 years

Study Arms (1)

People with chronic kidney disease

No interventions will be administered as part of this registry.

Other: Observational study - registry

Interventions

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.

People with chronic kidney disease

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geisinger Clinic

Danville, Pennsylvania, 17822, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36191726BACKGROUND

Related Links

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kerry Willis, PhD

    National Kidney Foudnation

    STUDY DIRECTOR

Central Study Contacts

Lesley A Inker, MD, MS

CONTACT

Kerry Willis, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
50 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2022

First Posted

August 11, 2022

Study Start

February 25, 2021

Primary Completion (Estimated)

February 24, 2070

Study Completion (Estimated)

February 24, 2070

Last Updated

May 13, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol Access

Locations