Status:
COMPLETED
Observational Secondary Data Study Describing Treatment With Dapagliflozin Among Adult Chronic Kidney Disease Patients
Lead Sponsor:
AstraZeneca
Conditions:
Chronic Kidney Disease (CKD)
Eligibility:
All Genders
18-130 years
Brief Summary
The OPTIMISE-CKD CEE study design will create a real-world evidence platform that systematically leverages the routine data collection made by Investigators and will help obtain relevant insights from...
Detailed Description
The OPTIMISE-CKD CEE study design will create a real-world evidence platform that systematically leverages the routine data collection made by Investigators and will help obtain relevant insights from...
Eligibility Criteria
Inclusion
- Adult patients (age ≥18 years) at the time of dapagliflozin start
- 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.
- Signed and dated informed consent prior to enrollment in the study.
Exclusion
- Diagnosed with type 1 diabetes \[ICD-10 codes E10 and O24.0\] at any time before index date.
- Diagnosed with gestational diabetes mellitus \[ICD-10 code O24.419\] at any time before index date.
- Patient is enrolled less than 30 days or more than 90 days, following initiation of dapagliflozin.
- Prior treatment (at any time before index date) with dapagliflozin or other SGLT-2i
- Enrolment in a clinical trial that includes specific treatments as investigational medicinal product on or 3 months before index date
- Renal transplant at any time before index date
- End stage renal disease (eGFR \<15 ml/min/1.73m2) on index date
- Chronic dialysis on or at any time before index date
Key Trial Info
Start Date :
December 20 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2025
Estimated Enrollment :
1086 Patients enrolled
Trial Details
Trial ID
NCT06203704
Start Date
December 20 2023
End Date
September 30 2025
Last Update
October 28 2025
Active Locations (56)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Plovdiv, Bulgaria
2
Research Site
Sofia, Bulgaria
3
Research Site
Varna, Bulgaria
4
Research Site
Zagreb, Croatia