Assessing the impact of KidneyIntelX on managing chronic kidney disease in diabetes patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the effectiveness of the KidneyIntelX assay in managing patients with chronic kidney disease and Type 2 diabetes within a primary care setting at Mount Sinai. The study aims to gather real-world evidence on how this assay influences clinical decision-making and patient outcomes. Participants will be monitored for their kidney health and management strategies over time, utilizing existing medical history and current standard care practices.

Why it matters

Who can join: the full rules

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.

Where it's running

• Mount Sinai Health System
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Roger Tun
• Email: rtun@renalytix.com
• Phone: 646-397-3970

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.