Real-world experience with Finerenone treatment in patients from India with chronic kidney disease and type 2 diabetes Retrospective data analysis.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
- 试验地点
- 12
- 主要终点
- Describe demographic and clinical characteristics comorbidities comedications and finerenone drug utilization patterns in patients with chronic kidney disease and Type 2 Diabetes treated with finerenone in routine clinical practice in India.
研究概览
简要总结
Diabetes mellitus is one of the most common causes of chronic kidney disease (CKD) and associated kidney failure. It has been estimated that globally about 20% and 40% of individuals with diabetes are diagnosed with diabetic nephropathy. More than 40% of patients with type 2 diabetes (T2D) had CKD in India. Patients with T2D and CKD are at a high risk of mortality. Based on the benefits noted in preclinical and clinical trials, the American Diabetes Association (ADA) and Kidney Disease: Improving Global Outcomes (KDIGO) recommend the usage of nonsteroidal mineralocorticoid receptor antagonist (nsMRA) for patients with T2D, normal serum potassium levels, estimated glomerular filtration rate (eGFR) 25 mL/min/1.73 m2 , and albumin-to creatinine ratio (ACR) 30 mg/g. Finerenone is a nsMRA that has been approved for the management of CKD among patients with T2D. The nsMRA has shown lower risk of hyperkalemia compared with traditional mineralocorticoid receptor antagonists (MRAs) like spironolactone. The benefits of finerenone in the primary and secondary prevention of cardiovascular (CV) events among patients with CKD and T2D have been established in various trials. As all safety and efficacy information currently available stems from controlled clinical trials that did not include Indian patients, we lack real-world data and experiences from routine clinical practice in India. Therefore, it is crucial to gather and evaluate data on the usage of finerenone shortly after its marketing approval, in patients prescribed this medication as part of their routine clinical care in India. Furthermore, it is essential to delineate patient characteristics and the patterns of drug utilization among these individuals to support the potential application of finerenone in clinical practice. The planned observational study is designed to obtain insights about the real-world treatment practice with finerenone in the clinical management of patients with CKD and T2D, across different patient care settings in India.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients from India (Indian ethnicity) diagnosed with CKD and T2D prior to initiating finerenone (per the standard diagnostic criteria) and initiated on finerenone per approved label.
- •Patient was prescribed finerenone for the first time (drug naive) for the management of CKD and T2D between 1st August 2022 and 30th April 2024.Age 18 years or older at the time of finerenone initiation.
排除标准
- •Patients with the following recorded data (on or within 90 days before finerenone initiation) will be excluded: eGFR less than 25 mL per min per 1.73 metre square Serum potassium more than 5.0 mmol per Litre Type 1 diabetes is recorded in the patient record Contraindications according to the local marketing authorization Patient data will be excluded if below information is identified in the patient record at any point from index date to the end of observation period: Pregnancy.
- •Patient taking concomitant medications that are strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin and nefazodone).
- •Addisons disease.
- •Patient was a part of an interventional clinical study between 1st August 2022 and 30th Nov 2024.
结局指标
主要结局
Describe demographic and clinical characteristics comorbidities comedications and finerenone drug utilization patterns in patients with chronic kidney disease and Type 2 Diabetes treated with finerenone in routine clinical practice in India.
时间窗: Patient information will be captured and entered the eCRF covering the baseline period, from 6 months prior to index until finerenone initiation (index), and during follow-up from 1 day after index until 30 November 2024 (or patient censorship)
次要结局
- • Assess absolute and relative changes in serum(potassium and key measures of kidney function)
研究者
Dr Pravin Manjrekar
Bayer Pharmaceuticals Private Limited