Real World Evidence Clinical Utility Study of KidneyIntelX

Real World Evidence Clinical Utility Study of KidneyIntelX

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT04802395

Recruitment Status : **RECRUITING NOW**
First Posted : March 17, 2021
Last Update Posted : March 29, 2023

Sponsor:

Collaborator:

Information provided by (Responsible Party):
Renalytix AI, Inc.

Go to 

Brief Summary:
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.

Chronic Kidney Diseases Diabetic Kidney Disease
Diagnostic Test: KidneyIntelX

Go to 

Layout table for study information

Study Type :
Observational

Estimated Enrollment :
10000 participants

Observational Model:
Cohort

Time Perspective:
Prospective

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

Actual Study Start Date :
March 2, 2021

Estimated Primary Completion Date :
December 2, 2023

Estimated Study Completion Date :
December 1, 2026

Resource links provided by the National Library of Medicine

Go to 

Intervention Details:

Diagnostic Test: KidneyIntelX
KidneyIntelX is an in-vitro diagnostic that enables accurate risk prediction of progressive decline in kidney function in patients with type 2 diabetes and existing CKD at stages 1-3 (eGFR of 30 to 59 ml/min/1.73m2, or eGFR ≥ 60 ml/min/1.73m2 and uACR ≥ 30 mg/g).

Go to 

Primary Outcome Measures :

Referrals [ Time Frame: 6 Months ]
Proportion (target: 20%) of patients referred to a dietician, diabetologist, or nephrologist.

Statins and or ACEi/ARB [ Time Frame: 6 Months ]
Proportion (target: 20% increase) of patients treated with statins and or angiotensin-converting-enzyme inhibitors and angiotensin II receptor blockers.

HbA1c [ Time Frame: 6 Months ]
Proportion (target: 20% increase) of patients to receive information and or advice on their individualized target of HbA1c.

SGLT2/ GLP1 [ Time Frame: 6 Months ]
Proportion (target: 20% increase) of patients treated with SGLT2 inhibitors or GLP1 agonists.

Go to 

Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:  
23 Years and older   (Adult, Older Adult)

Sexes Eligible for Study:  
All

Accepts Healthy Volunteers:  
No

Sampling Method:  
Non-Probability Sample

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

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.

Go to 

Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04802395

Layout table for location contacts

Contact: Roger Tun
646-397-3970 ext 106
rtun@renalytix.com

Layout table for location information

Mount Sinai Health System

New York, New York, United States, 10029

Renalytix AI, Inc.
Mount Sinai Hospital, New York

Go to 

Layout table for additonal information

Responsible Party:
Renalytix AI, Inc.

ClinicalTrials.gov Identifier:
NCT04802395    

Other Study ID Numbers:
RAI 19-1004

First Posted:
March 17, 2021    Key Record Dates

Last Update Posted:
March 29, 2023

Last Verified:
March 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:
Undecided

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:
No

Studies a U.S. FDA-regulated Device Product:
No

Additional relevant MeSH terms:

Layout table for MeSH terms

Kidney DiseasesRenal Insufficiency, ChronicDiabetic NephropathiesUrologic Diseases
Renal InsufficiencyDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

March 30, 2023Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
Comments