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NCT Number: NCT04802395

Real World Evidence Clinical Utility Study of KidneyIntelX

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.

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Diabetes Complications Diabetes Mellitus Diabetic Kidney Disease Diabetic Nephropathies Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

23 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mount Sinai Health System

New York, 10029, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Referrals

    Time frame: 6 Months

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

  2. Statins and or ACEi/ARB

    Time frame: 6 Months

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

  3. HbA1c

    Time frame: 6 Months

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

  4. SGLT2/ GLP1

    Time frame: 6 Months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Roger Tun

CONTACT

[email protected]

646-397-3970 ext. 106

Sponsors and collaborators

Lead sponsor

Renalytix AI, Inc.

Industry

Collaborators

  • Mount Sinai Hospital, New York

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Mar 17, 2021
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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