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Observational Secondary Data Study Describing Treatment With Dapagliflozin Among Adult Chronic Kidney Disease Patients

NCT06203704 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1086

Last updated 2025-10-28

No results posted yet for this study

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 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.

Conditions

  • Chronic Kidney Disease (CKD)

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-20
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • Bulgaria
  • Croatia
  • Hungary
  • Poland
  • Romania
  • Serbia
  • Slovenia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06203704 on ClinicalTrials.gov