An Observational Study of Patients With Chronic Kidney Disease

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).

Study Overview

• Status: Withdrawn
• Conditions: End Stage Kidney Disease; Kidney Disease, Chronic
• Intervention / Treatment: Other: Observational

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The study will include adults who are being managed for Stage 1-5 CKD or received a transplant for ESKD.

Description

Disease Cohort

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Disease Cohort	Other: Observational; Observational
Engaged Cohort	Other: Observational; Observational

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Target PharmaSolutions, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Actual): April 7, 2025
• Study Completion (Actual): April 7, 2025

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 17, 2023

Study Record Updates

• Last Update Posted (Estimated): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Kidney Failure, Chronic; Renal Insufficiency, Chronic; Health Services Administration; Quality of Health Care; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Watchful Waiting
• Other Study ID Numbers: TARGET-KIDNEY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No