Clinical Profile, Treatment Patterns and Evolution of the Urinary Albumin-to-creatinine Ratio in Patients With Type 2 Diabetes and Chronic Kidney Disease Treated With Finerenone at the Primary Care of the IMSS: Observational, Prospective, Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Evolution of the urinary albumin-to-creatinine ratio (uACR)
研究概览
简要总结
The main purpose of this study is to learn how treatment with finerenone affects the urinary albumin-to-creatinine ratio (uACR), a marker of kidney health, over time in adults with type 2 diabetes and chronic kidney disease who are receiving care in primary care clinics as part of their usual medical care. The study will help researchers better understand how finerenone is used and how people respond to treatment in everyday primary care settings.
This is an observational study, which means the study does not decide or assign treatment. Participants will receive finerenone only if their primary care doctor has already decided to prescribe it as part of routine medical care. The doctor will determine the starting dose and make any dose changes based on the participant's individual needs.
All participants will be enrolled in a single study group and followed for up to 12 months after starting finerenone. Information collected during routine primary care visits may include kidney health measurements, laboratory test results, other medications, healthcare use, and any side effects experienced during treatment. Follow-up assessments are planned around Month 1, Month 3, Month 6, and Month 12. Information about adverse events will be collected until 30 days after the participant's last dose of finerenone. The study will not require additional treatment decisions beyond routine care and aims to understand how finerenone performs in real-world primary care practice.
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
- •Adult participant - all genders (>=18 years old).
- •Documented diagnosis of Type 2 diabetes (T2D), according to clinical criteria used in routine clinical practice.
- •Documented diagnosis of Chronic Kidney Disease (CKD) in stages G2 to G3b, defined by an estimated glomerular filtration rate (Estimated Glomerular Filtration Rate [eGFR] >=30 and <90 mL/min/1.73 m^2 according to the information available in the clinical record).
- •Baseline urinary albumin-to-creatinine ratio (uACR) value >=30 mg/g, documented at the time of inclusion in the study.
- •Decision to initiate treatment with finerenone made by the physician as part of his or her routine clinical practice and independently of the patient's inclusion in the study.
- •Baseline serum potassium <5.0 mmol/L, determined prior to or at the time of inclusion in the study.
- •Signed informed consent.
- •Prescription of finerenone within the authorized indications and in accordance with the prescribing information in force in the local market.
- •No contraindications to the use of finerenone, in accordance with local marketing authorization and prescribing information in force.
排除标准
- •Concomitant participation in an interventional clinical study involving interventions outside of routine clinical practice at any time during the follow-up period of the present study.
- •Contra-indications according to the local label.
研究组 & 干预措施
Finerenone
Patients initiate finerenone according to routine clinical practice.
干预措施: Finerenone (Drug)
结局指标
主要结局
Evolution of the urinary albumin-to-creatinine ratio (uACR)
时间窗: Baseline and at months 1, 3, 6 and 12
Assessed by change from baseline at 1, 3, 6 and 12 months after initiation of finerenone treatment.
次要结局
- Proportion of patients achieving a clinically relevant reduction in uACR(Baseline and at months 1, 3, 6 and 12)
- Magnitude of the relative change in uACR(Baseline and at months 1, 3, 6 and 12)
- Adherence and persistence to finerenone treatment(12 months)
- Safety profile of finerenone(Up to 12 months)
- Use of health resources(Up to 12 months)