Evaluating the impact of KidneyIntelX on managing diabetic kidney disease
A Prospective Decision Impact Trial of KidneyIntelX in Patients With Type 2 Diabetes and Existing Chronic Kidney Disease
This study is testing if the KidneyIntelX test can help doctors better manage kidney disease in people with type 2 diabetes to improve their health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 23 Years and up |
| Sex | All |
| Sponsor | Renalytix AI, Inc. Industry-sponsored |
| Locations | 1 site (Slingerlands, New York) |
| Trial ID | NCT04791358 on ClinicalTrials.gov |
What this trial studies
This observational trial assesses how the KidneyIntelX test results influence the clinical management of patients with type 2 diabetes who are at increased risk for rapid kidney function decline. Participants must be 23 years or older and have evidence of diabetic kidney disease (DKD) stages 1-3. The study will track changes in clinical management based on the test outcomes over time. The goal is to determine if the test can lead to improved patient care and outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 23 and older with confirmed type 2 diabetes and evidence of diabetic kidney disease stages 1-3.
Not a fit: Patients with end-stage renal disease (ESRD), those not meeting the specific eGFR and albuminuria criteria, or those currently hospitalized will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management of diabetic kidney disease, potentially slowing the progression of kidney decline in at-risk patients.
How similar studies have performed: While this approach is relatively novel, previous studies have indicated that risk stratification tools can improve management in chronic conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 23 years of age or older. * Clinical history of confirmed type 2 diabetes. * Evidence of DKD Stages 1-3: * Baseline eGFR of 30-60 ml/min/1.73m2 (confirmed 3 months apart with at least one value within 1 year prior to enrollment) * Individuals with eGFR ≥60 ml/min/1.73m2 and albuminuria (UACR ≥30mg/g) * All patients will have a HbA1c, eGFR, urine albumin and urine creatinine, eGFR, available from within 12 months of enrollment (to be obtained if not clinically available prior). * The subject must be able to comprehend and sign an approved informed consent form and other applicable study documents. Exclusion Criteria: * 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 who are currently on Enbrel.
Where this trial is running
Slingerlands, New York
- Delmar Family Medicine — Slingerlands, 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.