Prospective Decision Impact Clinical Utility Trial of KidneyIntelX

Prospective Decision Impact Clinical Utility Trial 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: NCT05198284

Recruitment Status : **RECRUITING NOW**
First Posted : January 20, 2022
Last Update Posted : March 29, 2023

Sponsor:

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

Go to 

Brief Summary:
The clinical utility trial is designed to evaluate how the results of KidneyIntelX test / platform impacts on the clinical management of type 2 diabetes patients identified as increased risk for rapid kidney function decline within 5-years.

Diabetic Kidney Disease Chronic Kidney Diseases Chronic Kidney Disease Stage 1 Chronic Kidney Disease Stage 2 Chronic Kidney Disease Stage 3
Diagnostic Test: KidneyIntelX

Go to 

Layout table for study information

Study Type :
Observational

Estimated Enrollment :
2000 participants

Observational Model:
Cohort

Time Perspective:
Prospective

Official Title:
A Prospective Decision Impact Clinical Utility Trial of KidneyIntelX in Patients With Type 2 Diabetes and Existing Chronic Kidney Disease

Actual Study Start Date :
November 1, 2021

Estimated Primary Completion Date :
November 1, 2023

Estimated Study Completion Date :
November 1, 2026

Resource links provided by the National Library of Medicine

Go to 

Intervention Details:

Go to 

Primary Outcome Measures :

Blood pressure [ Time Frame: 12 Months ]
Proportion (target: 20% increase from prior measurements) of visits in which each participant achieves target blood pressure of <140/90 mmHg (as per the NKF CKD management guidelines).

HbA1c [ Time Frame: 12 Months ]
Proportion (target: 20% increase) of patients that achieve individualized target of HbA1c.

ACEi/ARB [ Time Frame: 12 Months ]
Proportion (target: 20% increase) of patients recently treated with statins and or angiotensin-converting-enzyme inhibitors and angiotensin II receptor blockers.

SGLT2/ GLP1 [ Time Frame: 12 Months ]
Proportion (target: 20% increase) of patients recently treated with SGLT2 inhibitors or GLP1 agonists.

Urine albumin to creatinine ratio [ Time Frame: 12 Months ]
In those with baseline albuminuria, proportion (target: 20%) of patients achieving a 30% decrease in their urine albumin to creatinine ratio from averaged pre-enrollment values to average post-enrollment values through 1 year.

Referrals [ Time Frame: 12 Months ]
Proportion (target: 20% increase) of patients referred/managed by a dietician, diabetologist, or nephrologist.

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:

23 years of age or older.
Clinical history of confirmed type 2 diabetes.
Evidence of DKD Stages 1-3:
Baseline eGFR of 30-59 ml/min/1.73m2 (confirmed 3 months apart with at least one value within 1 year prior to enrollment)
Individuals with eGFR ≥60 ml/min/1.73m2 and albuminuria (UACR ≥30mg/g)
All patients will have a HbA1c, eGFR, urine albumin and urine creatinine, eGFR, available from within 12 months of enrollment (to be obtained if not clinically available prior).
The subject must be able to comprehend and sign an approved informed consent form and other applicable study documents.

Exclusion Criteria:

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 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): NCT05198284

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

Contact: Catherine Sinfield         

Renalytix AI, Inc.

Layout table for investigator information

Principal Investigator:
David W Lam, MD
Mount Sinai Health System

Go to 

Layout table for additonal information

Responsible Party:
Renalytix AI, Inc.

ClinicalTrials.gov Identifier:
NCT05198284    

Other Study ID Numbers:
RAI 19-1002

First Posted:
January 20, 2022    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