Clinical Trials in the USA / NCT05198284
Active, not recruiting
Observational
Prospective Decision Impact Clinical Utility Trial of KidneyIntelX
NCT05198284 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Diabetic Kidney DiseaseChronic Kidney DiseasesChronic Kidney Disease Stage 1Chronic Kidney Disease Stage 2Chronic Kidney Disease Stage 3
Investigational drug(s) / intervention(s)
KidneyIntelX
KidneyIntelX: 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.
Study 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.
Eligibility
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.
Primary outcome measure(s)
- 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). - HbA1c — 12 Months
Proportion (target: 20% increase) of patients that achieve individualized target of HbA1c. - 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. - 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. - Referrals — 12 Months
Proportion (target: 20% increase) of patients referred/managed by a dietician, diabetologist, or nephrologist.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Mount Sinai Health System | New York | New York |
More Renalytix AI, Inc. trials in the USA
Prospective Decision Impact Trial of KidneyIntelX
Active, not recruiting
Decision Impact Trial of KidneyIntelX
Active, not recruiting
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05198284 on ClinicalTrials.gov ↗ ← All trials in the USA