Real World Evidence Clinical Utility Study of KidneyIntelX

Real World Evidence Clinical Utility Study of KidneyIntelX in Patients With Type 2 Diabetes and Chronic Kidney Disease

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04802395

Enrollment

10000

Registered

2021-03-17

Start date

2021-03-02

Completion date

2026-12-01

Last updated

2026-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases, Diabetic Kidney Disease

Brief summary

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.

Interventions

DIAGNOSTIC_TESTKidneyIntelX

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).

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

23 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* 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. * Patients who are currently hospitalized. * Patients without minimum 6 month pre-baseline KidneyIntelX medical history. * Patients who are currently on Enbrel.

Design outcomes

Primary

Measure	Time frame	Description
Referrals	6 Months	Proportion (target: 20%) of patients referred to a dietician, diabetologist, or nephrologist.
Statins and or ACEi/ARB	6 Months	Proportion (target: 20% increase) of patients treated with statins and or angiotensin-converting-enzyme inhibitors and angiotensin II receptor blockers.
HbA1c	6 Months	Proportion (target: 20% increase) of patients to receive information and or advice on their individualized target of HbA1c.
SGLT2/ GLP1	6 Months	Proportion (target: 20% increase) of patients treated with SGLT2 inhibitors or GLP1 agonists.

Countries

United States

Contacts

CONTACTRoger Tun

rtun@renalytix.com646-397-3970

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 14, 2026