Real World Evidence Clinical Utility Study of KidneyIntelX

Real World Evidence Clinical Utility Study of KidneyIntelX in Patients With Type 2 Diabetes and Chronic Kidney Disease

The purpose of this study is to assess the impact of the KidneyIntelX assay utilized as part of the current standard of care on the management of patients seen in the primary care physician's office at Mount Sinai.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Diseases; Diabetic Kidney Disease
• Intervention / Treatment: Diagnostic test: KidneyIntelX

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Roger Tun; Phone Number: 106 646-397-3970; Email: rtun@renalytix.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with Type 2 diabetes and existing chronic kidney disease stages 1-3.

Description

Inclusion Criteria:

• Individuals with Type 2 diabetes and concurrent chronic (diabetic) kidney disease (G3a-G3b or G1-G2, A2-A3) per KDIGO CKD staging.

Exclusion Criteria:

• Patents without the appropriate characteristics as identified in the KidneyIntelX intended use population.
• Patients with eGFR <30 or ≥ 60 ml/min/1.73m2 without albuminuria.
• Patients with ESRD or on renal recovery treatments at time of enrollment.
• Patients who are pregnant at the time of enrollment.
• Patients who are currently hospitalized.
• Patients without minimum 6 month pre-baseline KidneyIntelX medical history.
• Patients who are currently on Enbrel.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Referrals	Proportion (target: 20%) of patients referred to a dietician, diabetologist, or nephrologist.	6 Months
Statins and or ACEi/ARB	Proportion (target: 20% increase) of patients treated with statins and or angiotensin-converting-enzyme inhibitors and angiotensin II receptor blockers.	6 Months
HbA1c	Proportion (target: 20% increase) of patients to receive information and or advice on their individualized target of HbA1c.	6 Months
SGLT2/ GLP1	Proportion (target: 20% increase) of patients treated with SGLT2 inhibitors or GLP1 agonists.	6 Months

Collaborators and Investigators

• Sponsor: Renalytix AI, Inc.
• Collaborators: Mount Sinai Hospital, New York

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2021
• Primary Completion (Estimated): December 2, 2024
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 12, 2021
• First Submitted That Met QC Criteria: March 12, 2021
• First Posted (Actual): March 17, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Endocrine System Diseases; Disease Attributes; Diabetes Complications; Diabetes Mellitus; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Diabetic Nephropathies
• Other Study ID Numbers: RAI 19-1004

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