A Prospective Decision Impact Trial of KidneyIntelX in Patients With Type 2 Diabetes and Existing Chronic Kidney Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Renalytix AI, Inc.
- Enrollment
- 2,000
- Locations
- 1
- Primary Endpoint
- ACEi/ARB
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 23 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Referrals
Time Frame: 12 Months
Proportion (target: 20% increase) of patients referred/managed by a dietician, diabetologist, or nephrologist.
HbA1c
Time Frame: 12 Months
Proportion (target: 20% increase) of patients that achieve individualized target of HbA1c.
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).
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.
Secondary Outcomes
No secondary outcomes reported