An observational study in Chronic Kidney Disease and Type 2 Diabetes Mellitus, sponsored by Bayer. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-18.
Sponsored by Bayer · Observational
This is an observational study, in which data from people in the United States (US) with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied. The participants in this study are already receiving the study treatment finerenone as part of their regular care from their doctors.
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. The resulting high blood sugar levels can cause damage to the kidneys. CKD often occurs together with T2D or as a consequence of T2D.
Finerenone works by blocking certain proteins, called mineralocorticoid receptors. By doing this, it may reduce damage to kidneys, heart and blood vessels. Finerenone was recently approved in the US and is now available for doctors to prescribe to people with CKD together with T2D. Consequently, there is a need to collect more information about how finerenone is used, its safety and how well it works under real-world conditions.
The main purpose of this study is to collect and describe the characteristics of people with CKD and T2D who are receiving finerenone treatment as prescribed by their doctors. To do this, the researchers will collect data on:
The researchers will also collect data on kidney function and possible heart problems to find out how well finerenone works. Additionally, medical problems possibly related to finerenone treatment will be collected to learn more about how safe finerenone is in real-world use.
The data will come from US databases Optum Electronic Health Records (EHR) and OM1 Real-World Data Cloud (RWDC). They will cover the period from July 2021 to May 2023.
Only already available data is collected and studied. There are no required visits or tests in this study.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 15,948 is above the median of 192 across 1,033 observational studies indexed under Kidney Diseases.
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Persons initiating finerenone who have CKD and T2D will be included based on combinations of diagnosis codes of CKD and T2D, respectively, prescriptions and laboratory values (e.g., eGFR values or UACR measurements) indicating CKD and T2D.
CKD stages 2-4 related to eligibility will be defined according to the presence of the following criteria at any point before (and including) the index date:
Exclusion Criteria:
Kidney failure defined as:
Adults with CKD and T2D from the USA who initiate finerenone.
Drug: Finerenone (Kerendia, BAY948862)
Retrospective cohort analysis using United States Optum EHR data and OM1 RWDC databases.
Descriptive summary of characteristics of patients who initiate finerenone and have CKD and T2D in the US.
Time frame: Up to 365 days
Descriptive summary of comorbidities of patients who initiate finerenone and have CKD and T2D in the US.
Time frame: Up to 365 days
Descriptive summary of comedications of patients who initiate finerenone and have CKD and T2D in the US.
Time frame: Up to 180 days
Incidence rate of composite renal outcomes
Time frame: Up to 18 months
Incidence rate of composite cardiovascular outcomes
Time frame: Up to 18 months
Number of patients who initiate finerenone using a 10 mg dose and number of patients who have up-titrated to a 20 mg dose by 1, 3, 6, and 12 months, respectively.
Time frame: Up to 18 months
Number of patients who initiate finerenone using a 20 mg dose and number of patients who have down-titrated to a 10 mg dose by 1, 3, 6, and 12 months, respectively
Time frame: Up to 18 months
Incidence rate of hyperkalemia
Time frame: Up to 18 months
Incidence of hospitalization associated with a hyperkalemia event
Time frame: Up to 18 months
Change in UACR between baseline, at 4 months and end of follow up visit after initiating finerenone
UACR: Urine Albumin to Creatinine Ratio
Time frame: Up to 18 months
Change in eGFR between baseline, at 4 months and end of follow up visit after initiating finerenone
eGFR: Estimated Glomerular Filtration Rate
Time frame: Up to 18 months
Change in level of serum potassium between baseline and end of follow up visit after initiating finerenone
Time frame: Up to 18 months
Incidence rates of the respective component outcomes of the CV and renal composite outcomes
Time frame: Up to 18 months
Incidence rate of proliferative diabetic retinopathy in patients who initiate finerenone with prior non-proliferative diabetic retinopathy
Proliferative diabetic retinopathy is identified by the occurrence of an inpatient or outpatient diagnosis code for proliferative diabetic retinopathy.
Time frame: Up to 18 months
Plan to share: No — Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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