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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,086
- 试验地点
- 1
- 主要终点
- Dapagliflozin utilisation: to describe characteristics among patients who are treated with dapagliflozin.
研究概览
简要总结
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:
- 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.
详细描述
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. The results of the study will be used to better inform the medical community, and decision-makers about current and future needs in the CKD management in CEE in real-life setting. The approved label encompasses all CKD patients at risk of disease progression and is thereby broader than the DAPA-CKD trial population. It is important for physicians and patients to better understand dapagliflozin use in CKD in routine clinical practice, particularly among patients who might have been underrepresented in clinical trials. Additionally, payers require additional evidence from the broader CKD population prior to making reimbursement recommendations that will enable access for all patients who have the approved CKD indication.
It is important to assess the current CKD treatment with dapagliflozin. Primary objective is to characterize dapagliflozin utilisation in clinical practice, by describing treatment naïve patients who are treated with dapagliflozin for CKD.
To describe characteristics among patients newly initiated on dapagliflozin 10 mg for CKD, the following will be used:
- Baseline demographics and clinical characteristics
- Baseline laboratory measures
- Baseline concomitant medications, by drug class and specific drugs of interest.
Secondary objectives are to describe selected outcomes of interest and treatment patterns among CKD patients treated with dapagliflozin up to 12 months post-initiation:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 m
- •Signed and dated informed consent prior to enrollment in the study.
排除标准
- •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
结局指标
主要结局
Dapagliflozin utilisation: to describe characteristics among patients who are treated with dapagliflozin.
时间窗: 12 months prior to the index date
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
CLINICAL CHARACTERISTICS
时间窗: 12 months prior to the index date
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
ANTHROPOMETRIC CHARACTERISTICS at study index date
时间窗: 12 months prior to the index date
Weight / kg Height / cm
次要结局
- 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)