インドの慢性腎臓病と2型糖尿病の人々の日常診療におけるフィレレノンの安全性と効果について詳しく知るための観察研究 (IN-REALITY)

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.

The main purpose of the study is to learn more about how well finerenone works and how safe it is in Indian people with CKD and T2D. To do this, researchers will check:

• participants' characteristics including age, sex, height and weight, and signs and symptoms of the disease
• other conditions the participants may have along with CKD and T2D, additional medicines they have taken with finerenone, and different treatment patterns in Indian participants.

The different treatment pattern for finerenone includes:

• specialty of the doctor who prescribed finerenone
• the date of starting finerenone
• whether participants were still taking finerenone at each follow-up visit
• the date and reason for stopping finerenone early
• the dose of finerenone the participants took and how often they took it
• changes in the dosage either with a low dose or high dose compared with the previous firenone dose
• after starting finerenone treatment: reseachers may ask to continue treatment with finerenone, or may suggest adding other treatments like SGLT2 inhibitors or potassium binders, or stop finerenone treatment
• after stopping finerenone treatment: researchers may start other treatments, like SGLT2 inhibitors, RAAS inhibitors, or potassium binders or other therapy

Researchers will only look at the medical records from participants in India. Data collected will be from August 2022 to April 2024.

Researchers will track participants' data in India and will follow them until the end of the study period till Nov 2024, last visit date of the participant, the participant discontinues treatment with finerenone, death, kidney failure, or cancer of the kidney.

In this study, only available data from routine care in India are collected. No visits or tests are required as part of this study.