Prospective Decision Impact Trial of KidneyIntelX

Active, not recruiting

• Conditions: Diabetic Kidney Disease; Chronic Kidney Disease Stage 1; Chronic Kidney Disease Stage 2; Chronic Kidney Disease, Stage 3 (Moderate)

• Registration Number: NCT04960514
• Lead Sponsor: Renalytix AI, Inc.

Brief Summary

The current 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-02
• Study First Submitted QC: 2021-07-02
• Study First Posted: 2021-07-14
• Study Start: 2021-11-22
• Primary Completion: 2023-12-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood pressure	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).
ACEi/ARB	12 Months	Proportion (target: 20% increase) of patients recently treated with statins and or angiotensin-converting-enzyme inhibitors and angiotensin II receptor blockers.
Referrals	12 Months	Proportion (target: 20% increase) of patients referred/managed by a dietician, diabetologist, or nephrologist.
SGLT2/ GLP1	12 Months	Proportion (target: 20% increase) of patients recently treated with SGLT2 inhibitors or GLP1 agonists.
Urine albumin to creatinine ratio	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.
HbA1c	12 Months	Proportion (target: 20% increase) of patients that achieve individualized target of HbA1c.

Trial Locations

Locations (1)

Atrium Health Wake Forest Baptist - Family Medicine - Piedmont Plaza; 🇺🇸 Winston-Salem, North Carolina, United States