Health TrialsbyHealthPanel

Real World Evidence Clinical Utility Study of KidneyIntelX

ConditionsChronic Kidney DiseasesDiabetic Kidney Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age23+
SponsorRenalytix AI, Inc.

About this trial

The purpose of this study is to assess the impact of the KidneyIntelX assay utilized as part of the current standard of care on the management of patients seen in the primary care physician's office at Mount Sinai.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals with Type 2 diabetes and concurrent chronic (diabetic) kidney disease (G3a-G3b or G1-G2, A2-A3) per KDIGO CKD staging.

Disqualifiers

Patents without the appropriate characteristics as identified in the KidneyIntelX intended use population.

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.

Trial population

Patients with Type 2 diabetes and existing chronic kidney disease stages 1-3.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • KidneyIntelX

    Diagnostic test

    KidneyIntelX is an in-vitro diagnostic that enables accurate risk prediction of progressive decline in kidney function in patients with type 2 diabetes and existing CKD at stages 1-3 (eGFR of 30 to 59 ml/min/1.73m2, or eGFR ≥ 60 ml/min/1.73m2 and uACR ≥ 30 mg/g).

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Referrals

Proportion (target: 20%) of patients referred to a dietician, diabetologist, or nephrologist.

Time frame
6 Months
2

Statins and or ACEi/ARB

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

Time frame
6 Months
3

HbA1c

Proportion (target: 20% increase) of patients to receive information and or advice on their individualized target of HbA1c.

Time frame
6 Months
4

SGLT2/ GLP1

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

Time frame
6 Months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Renalytix AI, Inc.

Lead sponsor

Mount Sinai Hospital, New York

Collaborator

Source ClinicalTrials.gov
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