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Observing how dapagliflozin is used in adults with chronic kidney disease

OPTIMISE-CKD CEE: A Multinational, Observational, Secondary Data Study Describing Management and Treatment With Dapagliflozin in Routine Clinical Practice Among Patients With Chronic Kidney Disease in Central Eastern Europe

Observational AstraZeneca · NCT06203704

This study looks at how well dapagliflozin works for adults with chronic kidney disease in real-life situations to help doctors understand its benefits and usage better.

Quick facts

Study typeObservational
Enrollment1090 (estimated)
Ages18 Years to 130 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Locations58 sites (Plovdiv and 57 other locations)
Trial IDNCT06203704 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather real-world evidence on the use of dapagliflozin among adult patients with chronic kidney disease (CKD). By leveraging routine data collection, the study will assess treatment patterns, clinical outcomes, and the demographics of patients receiving dapagliflozin in a real-life setting. It will include a diverse population, providing insights that are more generalizable than those from traditional clinical trials. The findings will help inform healthcare providers and decision-makers about the management of CKD and the role of dapagliflozin in treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are adult patients aged 18 and older who are starting treatment with dapagliflozin for chronic kidney disease.

Not a fit: Patients with type 1 diabetes or those who do not meet the CKD diagnostic criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of dapagliflozin's effectiveness and safety in a broader CKD population, potentially improving patient outcomes.

How similar studies have performed: While this approach is observational and builds on existing knowledge, it aims to fill gaps left by previous clinical trials, making it a valuable addition to the body of research.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Plovdiv and 57 other locations

+8 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Kidney Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.