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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07348718
Eligibility Criteria:
Inclusion Criteria:
Age ≥18 years at the time of enrollment
Documented diagnosis of type 2 diabetes mellitus in the medical record
Evidence of chronic kidney disease consistent with diabetic kidney disease (DKD), defined by one or more of the following, with evidence of chronicity (present for ≥3 months based on prior laboratory results, diagnosis codes, or clinician documentation):
eGFR \<60 mL/min/1.73 m², and/or
Urine albumin-to-creatinine ratio (UACR) ≥30 mg/g
Receiving ongoing clinical care at a participating site with medical record data available for longitudinal follow-up
Able and willing to provide written informed consent (and authorization for medical record review, as applicable) and to complete registry questionnaires
Exclusion Criteria:
End-stage kidney disease at baseline (maintenance dialysis) or history of kidney transplant
Type 1 diabetes mellitus
Known primary kidney disease not primarily attributable to diabetes that, in the investigator's judgment, is expected to drive kidney outcomes (e.g., polycystic kidney disease, active glomerulonephritis, lupus nephritis, vasculitis)
Inability to provide informed consent or comply with registry procedures (e.g., no feasible longitudinal follow-up through the participating site)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07348718
Study Brief:
Protocol Section:
NCT07348718