This is an observational study, in which data from the past of people with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied. The participants in this study were treated in the past with a type of drug called SGLT2 inhibitor alone or with SGLT2 inhibitors in combination with finerenone. In observational studies, only observations are made without specified advice or interventions. CKD is a long-term progressive decrease in the kidneys' ability to work properly. In people with T2D, the body does not make enough of a hormone called insulin, or does not use insulin well enough, resulting in high blood sugar levels that can cause damage to the kidneys. Chronic kidney disease often occurs together with / as a consequence of type 2 diabetes. SGLT2 inhibitors lower blood sugar levels by increasing sugar removal from the blood into the urine. SGLT2 inhibitors are the standard of care (SOC) treatment for CKD and T2D. SOC is the treatment that medical experts consider most appropriate for a disease. The drug finerenone works by blocking certain proteins, called mineralocorticoid receptors. By doing this, finerenone reduces damage to kidneys, heart and blood vessels. It is available and approved for doctors to prescribe to people with CKD together with T2D. Results from two earlier clinical studies called FIDELIO-DKD and FIGARO-DKD in participants with CKD together with T2D are available. These results suggest that the treatment combination of finerenone and SGLT2 inhibitors may work better than taking SGLT2 inhibitors alone. The treatment combination may further slow down a worsening of the participants' * kidney disease * heart and blood circulation health. Due to a limited number of participants treated with SGLT2 inhibitors alone however, the data from the two earlier studies does not allow to draw conclusions. The main objective of this study is to combine additional real world data from SGLT2 inhibitor users with the study data from the earlier studies to get clearer results. Before combining the data however, statistical tests need to prove that this is allowed. If this is the case, the new combined "control" data can be compared with the data from the combination treatment group from the earlier studies. This will allow the researchers to get more proof and draw conclusions of how well the treatment combination works compared to SGLT2 inhibitors alone. The real world data will come from a database called Optum. It will cover the period from January 2013 to September 2021. Only data from people who are similar to the participants of the control group of the earlier studies and meet certain criteria will be selected. Only data from the past is collected and studied. There are no required visits or tests in this study.
Study Type
OBSERVATIONAL
Enrollment
17,847
Retrospective cohort analysis using randomized clinical trials data.
Retrospective cohort analysis using United States Optum Electronic Health Records data.
Bayer
Whippany, New Jersey, United States
Time to the first occurrence of the composite endpoint of onset of kidney failure, a sustained decrease of eGFR ≥ 40% from baseline over at least 4 weeks, or renal death
Time frame: From randomization up until the first occurrence of the primary renal composite endpoint, or censoring at the end of the study, with a maximum follow-up time of 48 months
Time to first occurrence of the composite endpoint of Cardiovascular (CV) death or non-fatal CV event (i.e. myocardial infarction, stroke, or hospitalization for heart failure)
Time frame: From randomization up until the first occurrence of the key secondary CV composite endpoint, or censoring at the end of the study, with a maximum follow-up time of 48 months
Time to all-cause hospitalization
Time frame: From randomization up until the first occurrence of the hospitalization due to any cause, or censoring at the end of study, with a maximum follow-up time of 48 months
Time to all-cause mortality
Time frame: From randomization up until death due to any cause, or censoring at the end of the study, with a maximum follow-up time of 48 months
Change in urine albumin-creatinine ratio (UACR) from baseline to Month 4
Time frame: From baseline to Month 4
Time to first occurrence of the following composite endpoint: onset of kidney failure, a sustained decrease in eGFR of ≥ 57% from baseline over at least 4 weeks or renal death
Time frame: From randomization up until the first occurrence of the composite primary endpoint, or censoring at the end of the study, with a maximum follow-up time of 48 months
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