check_circleStudy Completed
Chronic Kidney Disease, Heart Failure, Diabetes Mellitus
Bayer Identifier:
22113
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Real-world use of steroidal mineralocorticoid receptor antagonists - RELICS
Trial purpose
Steroidal Mineralocorticoid Receptor Antagonists (MRA) is a medication used to reduce the risk of kidney function decline, kidney failure, heart problems in adults with chronic kidney disease associated with type 2 diabetes into clinical practice, there is interest in better understanding the adverse drug reaction burden and discontinuation patterns associated with steroidal MRA use in the real world. We are conducting a study to understand how steroidal MRAs affect people in real life based on data from a medical database that collects medical claims. Our focus in this study is on the utilization of two steroidal MRAs, namely spironolactone and eplerenone. We want to learn about any negative effects and when people stop using this medication.
What We Want to Find Out
• We want to know how often people have negative reactions when they start using steroidal MRAs.
• We want to understand the different characteristics of people who start using this steroidal MRAs.
• We want to learn about how people use these steroidal MRAs and when they stop using it.
• We want to see how often people have health issues and need medical care when they start using these steroidal MRAs.
• We want to predict why people might stop using these steroidal MRAs.
Which Data was included
• Already existing data in a medical database based on medical claims
• Adults who recently started using a specific type of medication called sMRA (steroidal mineralocorticoid receptor antagonists).
• People who have had continuous health insurance for at least 12 months before they started using this medication.
• People who started using this medication between January 1, 2016, and May 31, 2021.
Different Groups in the Study
• People with chronic kidney disease (CKD) and type 2 diabetes (T2D)
• People with chronic kidney disease (CKD) but without type 1 or 2 diabetes (T2D/T1D)
• People with different types of heart failure (HF), or people with no clear type of heart failure
This study will help us understand how this medication affects different groups of patients.
What We Want to Find Out
• We want to know how often people have negative reactions when they start using steroidal MRAs.
• We want to understand the different characteristics of people who start using this steroidal MRAs.
• We want to learn about how people use these steroidal MRAs and when they stop using it.
• We want to see how often people have health issues and need medical care when they start using these steroidal MRAs.
• We want to predict why people might stop using these steroidal MRAs.
Which Data was included
• Already existing data in a medical database based on medical claims
• Adults who recently started using a specific type of medication called sMRA (steroidal mineralocorticoid receptor antagonists).
• People who have had continuous health insurance for at least 12 months before they started using this medication.
• People who started using this medication between January 1, 2016, and May 31, 2021.
Different Groups in the Study
• People with chronic kidney disease (CKD) and type 2 diabetes (T2D)
• People with chronic kidney disease (CKD) but without type 1 or 2 diabetes (T2D/T1D)
• People with different types of heart failure (HF), or people with no clear type of heart failure
This study will help us understand how this medication affects different groups of patients.
Key Participants Requirements
Sex
AllAge
18 YearsTrial summary
Enrollment Goal
224100Trial Dates
September 2022 - March 2023Phase
N/ACould I Receive a placebo
NoProducts
UnspecifiedAccepts Healthy Volunteer
NoPrimary Outcome
- To describe the incidence of adverse drug reactions in new users of Steroidal Mineralocorticoid Receptor Antagonists (sMRA)date_rangeTime Frame:intake period (01 JAN 2016 to 31 MAY 2021; Index = first observed sMRA fill).
Secondary Outcome
- To describe demographic and clinical characteristics of new users of sMRAsdate_rangeTime Frame:intake period (01 JAN 2016 to 31 MAY 2021; Index = first observed sMRA fill).
- To describe treatment patterns in new users of sMRAs, including treatment discontinuationdate_rangeTime Frame:intake period (01 JAN 2016 to 31 MAY 2021; Index = first observed sMRA fill).
- To describe the rate of clinical outcomes and healthcare resource utilization in new users of sMRAsdate_rangeTime Frame:intake period (01 JAN 2016 to 31 MAY 2021; Index = first observed sMRA fill).
- To describe predictors of treatment discontinuation in new users of sMRAs using standard regression modelsdate_rangeTime Frame:intake period (01 JAN 2016 to 31 MAY 2021; Index = first observed sMRA fill).
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A