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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:
Researcher will also count the number of participants in whom hyperkalemia:
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:
The participants will be in the study for approximately 20 months. They will take the study treatment once daily as a tablet by mouth for 18 months. In the study, 9 visits to the study site are planned.
During the study, the study team will:
About 30 days after the participants take their last treatment, the study doctors and their team will check worsening of reported underlying diseases:
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Inclusion criteria
Exclusion criteria
Contraindications according to the local marketing authorization:
Glycated hemoglobin > 12% (17.5 mmol/L) at the Screening visit.
Participants treated with another mineralocorticoid receptor antagonist (MRA), a renin inhibitor, potassium supplements, a potassium sparing diuretic, a potassium binder agent, or angiotensin receptor neprilysin inhibitor (ARNI) within 8 weeks prior to the Screening visit and during finerenone treatment.
Participation in another interventional clinical trial within 30 days prior to the Screening visit and during finerenone treatment.
Female participants who are pregnant or breast-feeding or plan to become pregnant or to breastfeed during the course of the study.
Participants known for lack of compliance with clinic visits or prescribed medication.
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Interventional model
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200 participants in 1 patient group
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Central trial contact
Bayer Clinical Trials Contact
Data sourced from clinicaltrials.gov
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