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A Study to Learn How Safe the Study Drug Finerenone is and How Well it Works in Indian People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 2 Diabetes Mellitus

Bayer · 2023
ClinicalTrials.gov · Datasets · License: Public Domain · 2023
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chronic-kidney-diseasetype-2-diabetes-mellitus
Researchers are looking for a better way to treat people with chronic kidney disease (CKD), a progressive decrease in the kidneys' ability to work properly, and type 2 diabetes (T2D). In people with T2D, the body does not make enough of a hormone called insulin or does not use the insulin well enough. Insulin's role is to regulate the amount of glucose (sugar) in the blood. Too much blood sugar can cause damage to the kidneys over time. Consequently, CKD can happen as one of the complications of T2D. The study treatment finerenone works by blocking a group of proteins, called mineralocorticoid receptor. An increased stimulation of the mineralocorticoid receptor is known to trigger injury and inflammation in the kidney and is therefore thought to play a role in CKD. Finerenone is already available in several countries for doctors to prescribe to people with CKD and T2D. In addition, it was recently approved in India with a request to specifically gather information on finerenone therapy in Indians. The main purpose of this study is to learn how safe finerenone is in Indian people with CKD and T2D. For this, the researchers will count the number of participants who have: * medical problems after taking finerenone * abnormal high levels of potassium in the blood (called hyperkalemia). Researcher will also count the number of participants in whom hyperkalemia: * leads to stop of finerenone treatment * requires treatment to filter wastes and water from the blood * leads to a hospital stay. Doctors keep track of all medical problems that happen in studies, even if they do not think the medical problems might be related to the study treatments. In addition, the study team will collect more data about how well finerenone works in Indian people with CKD and T2D under real world setting. Working well means that the treatment can prevent the following from happening: * reduced kidney function over a period of at least 4 weeks * death from renal problems * death due t
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