Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2025-12-24 @ 2:04 PM
NCT ID:
NCT04802395
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
23 Years
Study:
NCT04802395
Study Brief:
Protocol Section:
NCT04802395