Recruiting

Observational Study

Sponsor:

Tufts Medical Center

Code:

NCT05497518

Conditions

Chronic Kidney Disease

Dialysis

Kidney Transplant

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Observational study - registry

Study Details

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.

Conditions

Chronic Kidney Disease

Dialysis

Kidney Transplant

Study ID

NCT05497518

Start date

Feb 25, 2021

Status verified date

May, 2025

Completion date

Feb 24, 2070

Anticipated

Primary completion date

Feb 24, 2070

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50000 participants

Anticipated

Interventions and Outcome Measures

Arms

People with chronic kidney disease

No interventions will be administered as part of this registry.

Interventions

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.

Primary outcome measure

  • Total number of enrolled participants [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Locations

Geisinger Clinic

Recruiting

Danville, Pennsylvania, United States, 17822

Contacts

Principal Investigator:

Alexander Chang, MD, MS

More Information

Sponsor

Tufts Medical Center

Last update posted

May 13, 2025

Last verified

May, 2025

Keywords

  • Chronic kidney disease
  • Dialysis
  • Kidney transplant
  • Patient registry
  • Hereditary nephropathy
  • Genetic kidney disease
  • Rare kidney disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Tufts Medical Center on 2025-05-13.