Assessing the impact of KidneyIntelX on managing chronic kidney disease in diabetes patients
Real World Evidence Clinical Utility Study of KidneyIntelX in Patients With Type 2 Diabetes and Chronic Kidney Disease
This study tests if the KidneyIntelX tool can help doctors better manage kidney health in people with Type 2 diabetes and chronic kidney disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 23 Years and up |
| Sex | All |
| Sponsor | Renalytix AI, Inc. Industry-sponsored |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04802395 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals with Type 2 diabetes who also have chronic kidney disease as defined by specific KDIGO CKD staging criteria.
Not a fit: Patients without the appropriate characteristics for the KidneyIntelX intended use population or those with advanced kidney disease or other exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management of chronic kidney disease in diabetic patients, leading to better health outcomes.
How similar studies have performed: Other studies utilizing similar real-world evidence approaches have shown promise in improving patient management, suggesting potential for success in this study as well.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.