A Study Using Surveys to Learn More About Treatment With Steroidal Mineralocorticoid Receptor Antagonists, How They Are Used, What Side Effects They Have, and How Satisfied People Who Receive Them Are in the US

REal-world Use of steroidaL mIneralocorticoid reCeptor Antagonists - the RELICS Study - Patient Survey (PS)

This is an observational study in which patients with chronic kidney diseases (CKD), type 2 diabetes (T2D) or heart failure (HF) who are current or past users of sMRA therapies are studied. sMRA stands for steroidal mineralocorticoid receptor antagonists.

CKD is a long-term, progressive decrease in the kidneys' ability to work properly.

Type 2 diabetes is a condition in which the body does not make enough of a hormone called insulin or does not use insulin well resulting in high blood sugar levels.

HF is a condition in which the heart does not pump blood as well as it should.

The renin-angiotensin-aldosterone system (RAAS) is a hormone system that works with the kidneys to control blood pressure and the balance of fluid and electrolytes (like salt) in the blood. The RAAS has been a treatment target of heart and kidney diseases for decades. One of these classes of medications is called mineralocorticoid receptor (MR) antagonists (MRAs). MRAs work to directly block the action of a hormone called aldosterone. Aldosterone is produced naturally by the adrenal glands, and it can increase the blood volume and blood pressure. Using MRAs therapies can help prevent strokes, heart attacks and kidney problems.

Spironolactone was the first available MRA in the US with its approval in 1960. Eplerenone is another MRA which has been available since 2002. Both spironolactone and eplerenone are known as steroidal MRA (sMRA) due to their chemical structures.

The main purpose of this study is to collect more data on the characteristics of patients who are taking sMRA currently and those who have discontinued sMRA therapy in the past 12 months.

To do this, patients who have received sMRA in the most recent 12 months will be invited to participate in the study and asked to complete surveys if they agree to join the study. Patients will be found from administrative claims in a database called HealthCore Integrated Research Database (HIRD).

And the other purposes of the study are to learn more about:

• the indications for sMRA therapy
• the frequency and symptoms of reported side effects of sMRA treatment
• the treatment satisfaction and effectiveness as well as potential reasons for treatment continuation/discontinuation of sMRA therapies

Besides this data collection, no further tests or examinations are planned in this study.

The participants will receive their treatments as prescribed by their doctors during routine practice according to the approved product information.

Researchers will look at the health information from adult men and women in the US only if applicable who are current/past users of sMRA therapies with diagnosis of CKD or T2D or HF, consent to participate in the study.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Type 2 Diabetes Mellitus; Chronic Kidney Disease
• Intervention / Treatment: Other: sMRA therapies

• Study Type: Observational
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Whippany, New Jersey, United States, 07981
      • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who are current/past users of sMRA therapies who were diagnosed with chronic kidney disease, type 2 diabetes mellitus or heart failure, consent to participate in the study and have a valid survey.

Description

Inclusion Criteria:

• Currently active with commercial or Medicare Advantage health insurance (both medical and pharmacy benefits) at the time the patient sample is identified
• ≥1 pharmacy claim for a sMRA therapy (spironolactone or eplerenone) in the most recent 12-months of claims data
• ≥1 inpatient or ≥2 outpatient medical claims with an International Classification of Diseases, Ninth/Tenth Revision, Clinical Modification (ICD-9/10-CM) diagnosis code for CKD, T2D or HF going back to 1 Jan 2006
• Age ≥18 years at the end of the patient identification period
• Has email and/or mailing address
• Consent to participate in the survey

Exclusion Criteria:

- None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Survey on users of sMRA therapies; sMRA stands for steroidal mineralocorticoid receptor antagonist.	Other: sMRA therapies; No drug will be provided to participants. Patients follow routine clinical practice/administration.; Other Names: Steroidal mineralocorticoid receptor antagonist therapies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screening questions - to verify the participant's basic information and current health plan status and validate their current or recent use of sMRA therapy	sMRA stands for steroidal mineralocorticoid receptor antagonists.	Up to 12 months
Condition history - to confirm the diagnosis of CKD, T2D, or HF, determine the age at condition diagnosis, and the type of physician who currently manages/treats condition		Up to 12 months
sMRA discontinuer questions - questions for patients who have discontinued sMRA therapies, including duration of use, how long ago discontinued and most recent dose		Up to 12 months
sMRA continuing user questions - questions for patients who are current sMRA users including current sMRA therapy, how long used and most recent dose		Up to 12 months
Clinical characteristics		Up to 12 months
Demographic characteristics		Up to 12 months
Claims-based patient characteristics		Up to 12 months
Baseline comorbid conditions of interest		Up to 12 months
Baseline sMRA adherence and persistence		Up to 12 months
Baseline all-cause healthcare resource utilization by place of service		Up to 12 months
Baseline all-cause healthcare costs by place of service		Up to 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
sMRA discontinuer questions - targeted past medical history (indications for sMRA therapy) , reasons for choosing/discontinuing to sMRA therapy	Up to 12 months
sMRA continuing user questions - targeted past medical history (indications for sMRA therapy), reasons for choosing/continuing to use current sMRA	Up to 12 months
sMRA discontinuer questions - occurrence of sMRA side effects	Up to 12 months
sMRA continuing user questions - occurrence of sMRA side effects	Up to 12 months
sMRA discontinuer questions - reasons for discontinuing sMRA therapy, perceived effectiveness and overall satisfaction with the sMRA therapy	Up to 12 months
sMRA continuing user questions - Treatment Satisfaction Questionnaire for Medication version 1.4 (TSQM v1.4) - validated PROM the evaluates patients' perception of sMRA treatment effectiveness, convenience, and overall satisfaction	Up to 12 months

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2022
• Primary Completion (Actual): June 13, 2023
• Study Completion (Actual): June 13, 2023

Study Registration Dates

• First Submitted: June 2, 2022
• First Submitted That Met QC Criteria: June 2, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Urologic Diseases; Endocrine System Diseases; Disease Attributes; Diabetes Mellitus; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Mellitus, Type 2; Kidney Diseases; Renal Insufficiency, Chronic; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Natriuretic Agents; Diuretics; Hormone Antagonists; Diuretics, Potassium Sparing; Mineralocorticoid Receptor Antagonists; Mineralocorticoids
• Other Study ID Numbers: 22114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No