NCT06203704Completed
Observational Secondary Data Study Describing Treatment With Dapagliflozin Among Adult Chronic Kidney Disease Patients
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
Source: ClinicalTrials.gov · Last updated 28 Oct 2025
Brief summary (registry, in English)
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 clinical practice. This study is likely to include a more heterogeneous population compared with the constraints required by interventional study protocols. Treatment decisions, clinical outcomes, and common treatment scenarios in the context of routine care of CKD are likely to be more generalizable than those from clinical trials. It is important to assess the current CKD treatment with dapagliflozin. The research questions can be divided into two categories: 1. What does the dapagliflozin utilisation in CKD look like? a. Who are being treated? 2. What are the selected outcomes of interest and treatment patterns among CKD patients treated with dapagliflozin, with or without type 2 diabetes (T2D) up to 12 months post-initiation? Primary objective is to characterize dapagliflozin utilisation in clinical practice, by describing treatment naïve patients who are treated with dapagliflozin for CKD. Secondary objectives are to describe selected outcomes of interest and treatment patterns among CKD patients treated with dapagliflozin up to 12 months post-initiation. The OPTIMISE-CKD CEE study is a multinational, observational, longitudinal cohort study, with a pre-post design, which will include patients who are treated with dapagliflozin with CKD in real-world clinical practice, utilising secondary data sources. This is a secondary data collection study, where variables are extracted from electronic or paper medical records. Seven Central Eastern Europe countries are planned to participate in the study: Bulgaria, Croatia, Hungary, Poland, Romania, Serbia and Slovenia. A total number of 1090 patients are estimated to be included in the study. The study population will consist of adult patients with CKD who meet the country-specific label for dapagliflozin as treatment for CKD across CEE.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1086 (actual)
- First submitted
- 12 Dec 2023
- Start date
- 20 Dec 2023
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- AstraZeneca
- Diseases
- Chronic kidney disease
- NCT number
- NCT06203704
What you commit to
- Study type: Observational
- Participants enrolled: 1086
- From 20 Dec 2023 to the primary completion date, 30 Sept 2025
- 56 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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.
Lab values
- End stage renal disease (eGFR \<15 ml/min/1.73m2) on index date
Other
- Patient is enrolled less than 30 days or more than 90 days, following initiation of dapagliflozin.
- Chronic dialysis on or at any time before index date
Who the study is looking for
- 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.
Age in the registry: 18 years to 130 years · Sex: All · Does not accept healthy volunteers
Sites (56)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.