Real-world Experience With Finerenone Treatment in Patients From India With Chronic Kidney Disease and Type 2 Diabetes-Retrospective Data Analysis

Bayer1 个研究点分布在 1 个国家目标入组 1,200 人开始时间: 2025年9月22日最近更新: 2026年7月28日

适应症

干预措施

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 1,200
试验地点: 1
主要终点: Descriptive summary of specialty of prescribing physician

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

详细描述

This is an observational study in which data already collected from people with chronic kidney disease (CKD) and Type 2 diabetes mellitus (T2D) are studied.

T2D is a condition in which glucose levels rise in the blood. It is one of the common causes of CKD and can lead to kidney failure. CKD is a long-term condition in which the kidneys' ability to work properly gradually decreases over time.

The study drug, finerenone, is already approved for doctors to prescribe to people with CKD and T2D. It blocks the activity of a protein involved in worsening kidney function.

People with CKD and T2D are already receiving treatment with finerenone based on the results of previous studies. These studies, however, did not include Indian participants.

To better understand the impact of finerenone on CKD and T2D, more knowledge is needed about how well it works in the Indian population.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Retrospective

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 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 naïve) for the management of CKD and T2D between 1st August 2022 and 30th April
•Age 18 years or older at the time of finerenone initiation.

排除标准

•eGFR <25 mL/min/1.73 m^2
•Serum potassium >5.0 mmol/L
•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.
•- Lactation.
•- Patient taking concomitant medications that are strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin and nefazodone).
•- Addison's disease.
•Patient was a part of an interventional clinical study between 1st August 2022 and 30th Nov 2024.

研究组 & 干预措施

Finerenone (Kerendia, BAY948862)

Patients with CKD and T2D from India who initiate on finerenone per approved label.

干预措施: Finerenone (Kerendia, BAY948862) (Drug)