Recruiting

KidneyIntelX

Sponsor:

Renalytix AI, Inc.

Code:

NCT04802395

Conditions

Chronic Kidney Diseases

Diabetic Kidney Disease

Eligibility Criteria

Sex: All

Age: 23+

Healthy Volunteers: Not accepted

Interventions

KidneyIntelX

Study Details

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

Study ID

NCT04802395

Start date

Mar 2, 2021

Status verified date

Aug, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 23+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Interventions

KidneyIntelX

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 outcome measure

  • Referrals [ Time Frame: 6 Months ]
  • Statins and or ACEi/ARB [ Time Frame: 6 Months ]
  • HbA1c [ Time Frame: 6 Months ]
  • SGLT2/ GLP1 [ Time Frame: 6 Months ]

Central Contacts and Locations

Central contacts

Roger Tun

646-397-3970rtun@renalytix.com

Locations

Mount Sinai Health System

Recruiting

New York, New York, United States, 10029

More Information

Sponsor

Renalytix AI, Inc.

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Renalytix AI, Inc. on 2026-08-13.