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 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT06203704
Eligibility Criteria:
Inclusion Criteria:
1. Adult patients (age ≥18 years) at the time of dapagliflozin start
2. Patient receives treatment with dapagliflozin for CKD in accordance with the dapagliflozin product label and local dapagliflozin reimbursement criteria for CKD
Note: CKD diagnosis is based on the following KDIGO criteria \[KDIGO 2012\] that defines CKD as abnormalities of kidney structure or function, present for \>3 months, with implications for health and at least one of the following criteria:
* AER ≥30 mg/24 hours;
* ACR ≥30 mg/g (≥3 mg/mmol);
* eGFR \<60 ml/min/1.73 m2.
3. Signed and dated informed consent prior to enrollment in the study.
Exclusion Criteria:
1. Diagnosed with type 1 diabetes \[ICD-10 codes E10 and O24.0\] at any time before index date.
2. Diagnosed with gestational diabetes mellitus \[ICD-10 code O24.419\] at any time before index date.
3. Patient is enrolled less than 30 days or more than 90 days, following initiation of dapagliflozin.
4. Prior treatment (at any time before index date) with dapagliflozin or other SGLT-2i
5. Enrolment in a clinical trial that includes specific treatments as investigational medicinal product on or 3 months before index date
6. Renal transplant at any time before index date
7. End stage renal disease (eGFR \<15 ml/min/1.73m2) on index date
8. Chronic dialysis on or at any time before index date
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
130 Years
Study:
NCT06203704
Study Brief:
Protocol Section:
NCT06203704