Prospective Decision Impact Clinical Utility Trial of KidneyIntelX
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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23 years of age or older.
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Clinical history of confirmed type 2 diabetes.
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Evidence of DKD Stages 1-3:
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Baseline eGFR of 30-59 ml/min/1.73m2 (confirmed 3 months apart with at least one value within 1 year prior to enrollment)
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Individuals with eGFR ≥60 ml/min/1.73m2 and albuminuria (UACR ≥30mg/g)
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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).
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The subject must be able to comprehend and sign an approved informed consent form and other applicable study documents.
Exclusion Criteria:
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Patients with eGFR <30 or ≥ 60 ml/min/1.73m2 without albuminuria.
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Patients with ESRD or on renal recovery treatments at time of enrollment.
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Patients who are pregnant at the time of enrollment.
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Patients who are currently hospitalized.
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Patients who are currently on Enbrel.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mount Sinai Health System | New York | New York | United States | 10029 |
Sponsors and Collaborators
- Renalytix AI, Inc.
Investigators
- Principal Investigator: David W Lam, MD, Mount Sinai Health System
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RAI 19-1002