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

NCT06203704

CompletedN/A

Sponsor: AstraZeneca

Conditions: Chronic Kidney Disease (CKD)

Countries: Bulgaria, Croatia, Hungary, Poland, Romania, Serbia, Slovenia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility 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
Locations (56)
  • Plovdiv, Bulgaria
  • Sofia, Bulgaria
  • Varna, Bulgaria
  • Zagreb, Croatia
  • Békéscsaba, Hungary
  • Budapest, Hungary
  • Debrecen, Hungary
  • Gödöllő, Hungary
  • Karcag, Hungary
  • Kecskemét, Hungary
  • Miskolc, Hungary
  • Nagykanizsa, Hungary
  • Nyíregyháza, Hungary
  • Pécs, Hungary
  • Siófok, Hungary
  • Szeged, Hungary
  • Szombathely, Hungary
  • Veszprém, Hungary
  • Bialystok, Poland
  • Bolesławiec, Poland
  • Bydgoszcz, Poland
  • Choszczno, Poland
  • Czarnków, Poland
  • Katowice, Poland
  • Krakow, Poland
  • Lodz, Poland
  • Olsztyn, Poland
  • Opole, Poland
  • Sieradz, Poland
  • Szczecin, Poland
  • + 26 more on CT.gov