Real World Evidence Clinical Utility Study of KidneyIntelX

NCT04802395 | Recruiting

• 1 other identifier: RAI 19-1004
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; Diabetic Kidney Disease

Outcome Measures

Primary Outcomes (4)

• Referrals

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

  6 Months

• 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.

  6 Months

• HbA1c

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

  6 Months

• SGLT2/ GLP1

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

  6 Months

Interventions

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).

Eligibility Criteria

• Age: 23 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Renalytix AI, Inc.: lead
• Mount Sinai Hospital, New York: collaborator

Study Sites (1)

Mount Sinai Health System

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetic Nephropathies

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Roger Tun

CONTACT

646-397-3970; rtun@renalytix.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 17, 2021
• Study Start: March 2, 2021
• Primary Completion: December 2, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

US (1)