Recruiting NCT04802395
Real World Evidence Clinical Utility Study of KidneyIntelX
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: KidneyIntelX.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Diseases, Diabetic Kidney Disease. Basic parameters: from 23 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Real World Evidence Clinical Utility Study of KidneyIntelX in Patients With Type 2 Diabetes and Chronic Kidney Disease
Overview
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.
Interventions
- Diagnostic test 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 measures
- 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]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mount Sinai Health System — New York
Identifiers
NCT: NCT04802395 · RAI 19-1004