An Observational Study of Patients With Chronic Kidney Disease

Not yet recruiting

• Conditions: Kidney Disease, Chronic; End Stage Kidney Disease
• Interventions: Other: Observational

• Registration Number: NCT05774392
• Lead Sponsor: Target PharmaSolutions, Inc.

Brief Summary

TARGET-KIDNEY is an observational research study to conduct a comprehensive review of outcomes for patients with chronic kidney disease (CKD) and end-stage renal disease (ESKD).

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-07
• Study First Submitted QC: 2023-03-07
• Study First Posted: 2023-03-17
• Last Update Submitted: 2023-03-31
• Last Update Posted: 2023-04-05
• Study Start: 2023-05
• Primary Completion: 2037-12
• Study Completion: 2037-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500000

Inclusion Criteria

• Adult* patients at the time of enrollment with a diagnosis of CKD/ESKD by ICD-10 code in the EHR interface

Exclusion Criteria

• Death
• Manual removal (sponsor or site request)
• No EHR interface encounter > 3 years

Engaged Cohort

Inclusion Criteria:

• Adult * patients diagnosed and managed for CKD/ESKD invited to participate
• Ability to provide written informed consent

Exclusion Criteria:

• Patient expressed desire to withdraw consent to complete PROs
• Failure to complete PROs within 24 weeks of initial invitation
• Greater than 24 months lapse of survey completion after baseline surveys completed
• Additionally, the criteria detailed for Disease Cohort apply to the Engaged Cohort

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Engaged Cohort	Observational	-
Disease Cohort	Observational	-

Primary Outcome Measures

Name	Time	Method
To characterize the natural history of disease in patients with CKD/ESKD.	20 Years
To assess safety and effectiveness of CKD/ESKD treatments and treatments for complications of either condition	20 Years

Secondary Outcome Measures

Name	Time	Method
To evaluate provider management practices in the treatment of patients with CKD/ESKD	20 Years
To select and evaluate quality of care measures for patients with CKD/ESKD	20 Years
To evaluate longitudinal and patient reported outcomes in CKD/ESKD	20 Years