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

NCT06203704 | Completed

• 1 other identifier: D169AR00025
• Study Type: observational
• Target: 1,086
• Locations: 7 countries
• Sites: 56

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 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. 1.What does the dapagliflozin utilisation in CKD look like?
2. 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?

Conditions

Chronic Kidney Disease (CKD)

Outcome Measures

Primary Outcomes (3)

• Dapagliflozin utilisation: to describe characteristics among patients who are treated with dapagliflozin.

  Baseline selected event rates (hospitalizations: all-cause, and cardiorenal) / number of events per year. Baseline concomitant medications, by drug class and specific drugs of interest

  12 months prior to the index date

• ANTHROPOMETRIC CHARACTERISTICS at study index date

  Weight / kg Height / cm

  12 months prior to the index date

• CLINICAL CHARACTERISTICS

  Year of initial diagnosis of CKD / year eGFR / ml/min/1.73 m2 Urine albumin-to-creatinine ratio (uACR) / mg/mmol Urine protein-to-creatinine ratio (uPCR) / mg/g

  12 months prior to the index date

Secondary Outcomes (2)

• To describe selected outcomes of interest and treatment patterns among CKD patients treated with dapagliflozin

  12 months after Index

• CLINICAL CHARACTERISTICS

  12 MONTHS SINCE INDEX DATE

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will consist of adult patients with CKD who meet the country-specific label for dapagliflozin as treatment for CKD across CEE. Patients newly initiated on treatment with dapagliflozin for CKD will be eligible for enrolment by physicians from both outpatient and inpatient settings.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (56)

Research Site

Plovdiv, Bulgaria

Location

Research Site

Sofia, Bulgaria

Location

Research Site

Varna, Bulgaria

Location

Research Site

Zagreb, Croatia

Location

Research Site

Békéscsaba, Hungary

Location

Research Site

Budapest, Hungary

Location

Research Site

Debrecen, Hungary

Location

Research Site

Gödöllő, Hungary

Location

Research Site

Karcag, Hungary

Location

Research Site

Kecskemét, Hungary

Location

Research Site

Miskolc, Hungary

Location

Research Site

Nagykanizsa, Hungary

Location

Research Site

Nyíregyháza, Hungary

Location

Research Site

Pécs, Hungary

Location

Research Site

Siófok, Hungary

Location

Research Site

Szeged, Hungary

Location

Research Site

Szombathely, Hungary

Location

Research Site

Veszprém, Hungary

Location

Research Site

Bialystok, Poland

Location

Research Site

Bolesławiec, Poland

Location

Research Site

Bydgoszcz, Poland

Location

Research Site

Choszczno, Poland

Location

Research Site

Czarnków, Poland

Location

Research Site

Katowice, Poland

Location

Research Site

Krakow, Poland

Location

Research Site

Lodz, Poland

Location

Research Site

Olsztyn, Poland

Location

Research Site

Opole, Poland

Location

Research Site

Sieradz, Poland

Location

Research Site

Szczecin, Poland

Location

Research Site

Środa Wielkopolska, Poland

Location

Research Site

Węgrów, Poland

Location

Research Site

Wroclaw, Poland

Location

Research Site

Zielona Góra, Poland

Location

Research Site

Żywiec, Poland

Location

Research Site

Bistriţa, Romania

Location

Research Site

Bucharest, Romania

Location

Research Site

Cluj-Napoca, Romania

Location

Research Site

Galati, Romania

Location

Research Site

Iași, Romania

Location

Research Site

Oradea, Romania

Location

Research Site

Reşiţa, Romania

Location

Research Site

Satu Mare, Romania

Location

Research Site

Târgu Mureş, Romania

Location

Research Site

Timișoara, Romania

Location

Research Site

Belgrade, Serbia

Location

Research Site

Brežice, Slovenia

Location

Research Site

Cerknica, Slovenia

Location

Research Site

Mengeš, Slovenia

Location

Research Site

Portorož, Slovenia

Location

Research Site

Ptuj, Slovenia

Location

Research Site

Radlje ob Dravi, Slovenia

Location

Research Site

Ruše, Slovenia

Location

Research Site

Sevnica, Slovenia

Location

Research Site

Škofja Loka, Slovenia

Location

Research Site

Zagorje, Slovenia

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: January 12, 2024
• Study Start: December 20, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: October 28, 2025

Record last verified: 2025-10

Locations

RO (10); SL (10); SE (1); BU (3); CR (1); HU (14); PL (17)