Ignite Creation Date:
2024-05-06 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05705271
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2023-01-20
Brief Title:
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
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
A Prospective Interventional Multicenter Phase IV Open-label Single Arm Study to Assess the Safety and Effectiveness of Finerenone in Participants From India With Chronic Kidney Disease Associated With Type 2 Diabetes
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 Insulins 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 to conditions affecting the heart and blood circulation
heart attack blocked blood flow to the heart
hospital stay due to a condition which occurs when the heart does not pump blood as well as it should
changes of the albumin and creatinine levels in urine
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
take blood and urine samples
do physical examinations
check the participants overall health
do pregnancy tests
examine heart health using electrocardiogram ECG
check vital signs
About 30 days after the participants take their last treatment the study doctors and their team will check worsening of reported underlying diseases
damage to the blood vessels in the tissue of the retina at the back of the eye as a result of diabetes mellitus
a long-term condition where the heart does not pump blood as well as it should with symptoms such as shortness of breath tiredness and ankle swelling
heart attack blocked blood flow to the heart
death due to conditions affecting the heart and blood circulation or
hospital stay
In people with T2D the body does not make enough of a hormone called insulin or does not use the insulin well enough Insulins 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 to conditions affecting the heart and blood circulation
heart attack blocked blood flow to the heart
hospital stay due to a condition which occurs when the heart does not pump blood as well as it should
changes of the albumin and creatinine levels in urine
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
take blood and urine samples
do physical examinations
check the participants overall health
do pregnancy tests
examine heart health using electrocardiogram ECG
check vital signs
About 30 days after the participants take their last treatment the study doctors and their team will check worsening of reported underlying diseases
damage to the blood vessels in the tissue of the retina at the back of the eye as a result of diabetes mellitus
a long-term condition where the heart does not pump blood as well as it should with symptoms such as shortness of breath tiredness and ankle swelling
heart attack blocked blood flow to the heart
death due to conditions affecting the heart and blood circulation or
hospital stay
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None