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.

Key Participants Requirements

Sex

All

Age

18 Years
  • • At least one pharmacy claim for sMRA during the Intake Period. First fill date is the Index Date.
    • No claim for sMRA any time prior (01 JAN 2006) to the Index Date.
    • At least 18 years old as of the Index Date.
    • Continuously enrolled in health plan during the 12 Months Pre-Index Period.
    • For each subgroup, at least one diagnosis in the inpatient setting or at least two claims in any other place of service for the condition of interest during the Full Pre-Index Period through 6 months after the Index Date.
    - Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM)
    - Chronic Kidney Disease (CKD) and Type 1 Diabetes Mellitus (T1DM)
    -CKD without T1DM and T2DM
    o Heart Failure
    - HFpEF (preserved ejection fraction)
    - HFrEF (reduced ejection fraction)
  • Not applicable

Trial summary

Enrollment Goal
224100
Trial Dates
September 2022 - March 2023
Phase
N/A
Could I Receive a placebo
No
Products
Unspecified
Accepts Healthy Volunteer
No

Primary 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 sMRAs
    date_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 discontinuation
    date_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 sMRAs
    date_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 models
    date_rangeTime Frame:
    intake period (01 JAN 2016 to 31 MAY 2021; Index = first observed sMRA fill).

Trial design

REal-world use of steroidaL mIneralocorticoid reCeptor antagonists – the RELICS study
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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