Prospective Decision Impact Clinical Utility Trial of KidneyIntelX

N/AActive Not RecruitingNCT05198284

Renalytix AI, Inc.2,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,000

Conditions

Diabetic Kidney Disease Chronic Kidney Diseases Chronic Kidney Disease Stage 1 Chronic Kidney Disease Stage 2 Chronic Kidney Disease Stage 3

Interventions

KidneyIntelXDIAGNOSTIC_TEST

KidneyIntelX is a blood-based clinical diagnostic tool that assesses the risk of progressive kidney function decline in chronic kidney disease patients with type 2 diabetes.

Eligibility

Sex: ALLMin age: 23 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mount Sinai Health System

New York, New York, United States

Outcomes

Primary Outcomes

Blood pressure

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).

Time frame: 12 Months

HbA1c

Proportion (target: 20% increase) of patients that achieve individualized target of HbA1c.

Time frame: 12 Months

ACEi/ARB

Proportion (target: 20% increase) of patients recently treated with statins and or angiotensin-converting-enzyme inhibitors and angiotensin II receptor blockers.

Time frame: 12 Months

SGLT2/ GLP1

Proportion (target: 20% increase) of patients recently treated with SGLT2 inhibitors or GLP1 agonists.

Time frame: 12 Months

Urine albumin to creatinine ratio

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.

Time frame: 12 Months

Referrals

Proportion (target: 20% increase) of patients referred/managed by a dietician, diabetologist, or nephrologist.

Time frame: 12 Months

Data from ClinicalTrials.gov

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