An Observational Prospective Study to Analyse Changes in the Klinrisk Chronic Kidney Disease Progression Model Score in a Cohort of Patients With CKD Associated With Type 2 Diabetes Treated With Finerenone in Spain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Percentage of patients who show an improvement in the Klinrisk model score after 24 months of treatment with finerenone.
研究概览
简要总结
This is a prospective observational study in which data from people with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) who will be receiving finerenone are collected and analyzed.
Chronic kidney disease (CKD) is common in people with type 2 diabetes. It can get worse over time and may lead to kidney failure and heart problems. Doctors often track kidney health using blood and urine tests, including the estimated glomerular filtration rate (eGFR) and the urine albumin-to-creatinine ratio (UACR). There are also tools that combine routine laboratory test results to estimate a person's risk of their kidney disease getting worse. One of these tools is called the Klinrisk model.
The study drug, finerenone, is already approved for doctors to prescribe to patients with CKD associated with T2D and albumin in the urine.
Finerenone works by blocking the mineralocorticoid receptor, a protein involved in inflammation and scarring in the kidneys and heart. The study drug, finerenone, is a non-steroidal mineralocorticoid receptor modulator that aims to reduce harmful kidney and heart changes.
The main purpose of this study is to determine whether the Klinrisk score improves after 2 years of treatment with finerenone in adults with CKD associated with T2D who are treated in routine care. To achieve this, researchers will collect data on:
- Clinical characteristics of participants, including their medical history related to CKD and T2D.
- Variables used to assess the CKD progression, such as eGFR, UACR, and Blood Urea Nitrogen (BUN).
- Participants' glucose, hemoglobin and potassium levels.
The study will also monitor any medical problems (known as adverse events) that participants may experience during the study. All adverse events will be recorded, regardless of whether they are related to the treatment.
Data will be collected from April 2026 to April 2029 and will cover a period of up to 24 months per participant. Data collection will occur over 5 visits that coincide with routine clinical care: inclusion, follow-up visits at 6, 12, and 18 months (±1 month), and a final visit at 24 months (±1 month).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who sign the written informed consent to participate in the study.
- •Men or women aged ≥18 years.
- •Patients with CKD associated with type 2 diabetes and albuminuria (UACR >30 mg/g).
- •Patients initiated on finerenone in routine clinical practice, according to the Summary of Product Characteristics (SmPC), within the 2 months prior to inclusion.
排除标准
- •eGFR < 25 mL/min/1.73 m².
- •Severe hepatic impairment.
- •Clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and persistent symptoms.
- •Confirmed significant non-diabetic renal disease, including clinically relevant renal artery stenosis.
- •Uncontrolled arterial hypertension (mean sitting systolic blood pressure [SBP] ≥160 mmHg or diastolic blood pressure [DBP] ≥100 mmHg at inclusion).
- •Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or a potassium-sparing diuretic that has not been discontinued at least 4 weeks prior to inclusion.
研究组 & 干预措施
Participants diagnosed with CKD and T2D
Participants who are newly prescribed finerenone under routine treatment conditions.
干预措施: Finerenone (Kerendia, BAY94-8862) (Drug)
结局指标
主要结局
Percentage of patients who show an improvement in the Klinrisk model score after 24 months of treatment with finerenone.
时间窗: Up to 24 months from the beginning of treatment with finerenone.
次要结局
- Incidence rate of death from CV causes.(Up to 24 months from the beginning of treatment with finerenone.)
- Incidence rate of nonfatal myocardial infarction.(Up to 24 months from the beginning of treatment with finerenone.)
- Incidence rate of nonfatal stroke.(Up to 24 months from the beginning of treatment with finerenone.)
- Incidence rate of hospitalization for heart failure.(Up to 24 months from the beginning of treatment with finerenone.)
- Percentage of patients who show an improvement in the Klinrisk model score after 12 months of treatment with finerenone.(Up to 12 months from the beginning of treatment with finerenone.)
- Cumulative incidence (%) of the composite outcome of kidney failure, a sustained decrease of at least 40% in the eGFR from the beginning of treatment with finerenone (index date), or death from renal causes.(Up to 24 months from the beginning of treatment with finerenone.)
- Cumulative incidence (%) of hospitalizations for heart failure.(Up to 24 months from the beginning of treatment with finerenone.)
- Time to the composite endpoint of renal outcomes.(Up to 24 months from the beginning of treatment with finerenone.)
- Cumulative incidence (%) for kidney failure.(Up to 24 months from the beginning of treatment with finerenone.)
- Cumulative incidence (%) for sustained decrease in eGFR to <15 mL/min/1.73 m2 maintained for at least 4 weeks.(Up to 24 months from the beginning of treatment with finerenone.)
- Cumulative incidence (%) for sustained ≥40% eGFR decline from baseline maintained for at least 4 weeks.(Up to 24 months from the beginning of treatment with finerenone.)
- Cumulative incidence (%) of KRT.(Up to 24 months from the beginning of treatment with finerenone.)
- Cumulative incidence (%) of death from renal causes.(Up to 24 months from the beginning of treatment with finerenone.)
- Change in UACR at months 6, 12, 18 and 24 (> 30%, 40% or >50%)(At months 6, 12, 18 and 24.)
- Change in eGFR chronic slope at months 6, 12, 18 and 24.(At months 6, 12, 18 and 24.)
- Levels of NT-proBNP values.(Up to 24 months from the beginning of treatment with finerenone.)
- Cumulative incidence (%) of the composite outcome of death from CV causes, nonfatal myocardial infarction, nonfatal stroke or hospitalization for heart failure.(Up to 24 months from the beginning of treatment with finerenone.)
- Cumulative incidence (%) of death from CV causes.(Up to 24 months from the beginning of treatment with finerenone.)
- Cumulative incidence (%) of nonfatal myocardial infarction.(Up to 24 months from the beginning of treatment with finerenone.)
- Cumulative incidence (%) of nonfatal stroke.(Up to 24 months from the beginning of treatment with finerenone.)
- Number of adverse events (AEs) that occur during the study period.(Up to 30 days after the final treatment with finerenone.)
- Number of discontinuations of finerenone for AEs.(Up to 24 months from the beginning of treatment with finerenone.)
- Number of hospitalizations for AEs.(Up to 24 months from the beginning of treatment with finerenone.)
- Percentage of patients with hypokalemia, normokalemia and hyperkalemia.(Up to 24 months from the beginning of treatment with finerenone.)
- Percentage of patients who maintain normokalemia over the entire follow-up.(Up to 24 months from the beginning of treatment with finerenone.)
- Incidence of acute kidney injury (AKI) requiring hospitalization.(Up to 24 months from the beginning of treatment with finerenone.)