Chronic Kidney DiseaseNCT05407662
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
An observational study of Chronic Kidney Disease and Type 2 Diabetes Mellitus, run by Bayer at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Type 2 Diabetes Mellitus, Heart Failure
- What is being tested?
- sMRA therapies
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2022to 13 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Being tested
- sMRA therapies
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sMRA therapiesOther
Also called Steroidal mineralocorticoid receptor antagonist therapies
No drug will be provided to participants. Patients follow routine clinical practice/administration.
| Study group | Role | What they receive |
|---|---|---|
| Survey on users of sMRA therapies | sMRA stands for steroidal mineralocorticoid receptor antagonist. Receives: Other: sMRA therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 12 months
Clinical characteristics
Measured: Up to 12 months
Demographic characteristics
Measured: Up to 12 months
Claims-based patient characteristics
Measured: Up to 12 months
Baseline comorbid conditions of interest
Measured: Up to 12 months
Baseline sMRA adherence and persistence
Measured: Up to 12 months
Baseline all-cause healthcare resource utilization by place of service
Measured: Up to 12 months
Baseline all-cause healthcare costs by place of service
Measured: Up to 12 months
Secondary outcomes (6)
sMRA discontinuer questions - targeted past medical history (indications for sMRA therapy) , reasons for choosing/discontinuing to sMRA therapy
Measured: Up to 12 months
sMRA continuing user questions - targeted past medical history (indications for sMRA therapy), reasons for choosing/continuing to use current sMRA
Measured: Up to 12 months
sMRA discontinuer questions - occurrence of sMRA side effects
Measured: Up to 12 months
sMRA continuing user questions - occurrence of sMRA side effects
Measured: Up to 12 months
sMRA discontinuer questions - reasons for discontinuing sMRA therapy, perceived effectiveness and overall satisfaction with the sMRA therapy
Measured: 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
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start2 Nov 2022
- Primary completion13 Jun 2023
- Study completion13 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407662
- Sponsor's protocol ID
- 22114
- Status last verified
- Sep 2023
- First submitted
- 2 Jun 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REal-world Use of steroidaL mIneralocorticoid reCeptor Antagonists - the RELICS Study - Patient Survey (PS)
- ClinicalTrials.gov ID
- NCT05407662
- Acronym / sponsor ID
- 22114
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 13 Jun 2023 (actual)
- Study completion
- 13 Jun 2023 (actual)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Survey on users of sMRA therapies | – | Other: sMRA therapiessMRA stands for steroidal mineralocorticoid receptor antagonist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sMRA therapiesAlso: Steroidal mineralocorticoid receptor antagonist therapiesNo drug will be provided to participants. Patients follow routine clinical practice/administration. | Other | Survey on users of sMRA therapies |
Primary outcome
Screening questions - to verify the participant's basic information and current health plan status and validate their current or recent use of sMRA therapy
Time frame: Up to 12 months
sMRA stands for steroidal mineralocorticoid receptor antagonists.
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
Time frame: 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
Time frame: 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
Time frame: Up to 12 months
Clinical characteristics
Time frame: Up to 12 months
Demographic characteristics
Time frame: Up to 12 months
Claims-based patient characteristics
Time frame: Up to 12 months
Baseline comorbid conditions of interest
Time frame: Up to 12 months
Baseline sMRA adherence and persistence
Time frame: Up to 12 months
Baseline all-cause healthcare resource utilization by place of service
Time frame: Up to 12 months
Baseline all-cause healthcare costs by place of service
Time frame: Up to 12 months
6 secondary outcomes
sMRA discontinuer questions - targeted past medical history (indications for sMRA therapy) , reasons for choosing/discontinuing to sMRA therapy
Time frame: Up to 12 months
sMRA continuing user questions - targeted past medical history (indications for sMRA therapy), reasons for choosing/continuing to use current sMRA
Time frame: Up to 12 months
sMRA discontinuer questions - occurrence of sMRA side effects
Time frame: Up to 12 months
sMRA continuing user questions - occurrence of sMRA side effects
Time frame: Up to 12 months
sMRA discontinuer questions - reasons for discontinuing sMRA therapy, perceived effectiveness and overall satisfaction with the sMRA therapy
Time frame: 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
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: 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.
Related trials for Chronic Kidney Disease
RecruitingObservational study
Immune System Related Kidney Disease
Kidney Disease, Nephrotic Syndrome
Recruiting
Diuretic Tuner Clinical Decision Support
Edema, Hypervolemia
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Chronic Kidney Disease (CKD)
Chronic Kidney Diseases
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
Diabetes, End Stage Renal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease and Type 2 Diabetes Mellitus, run by Bayer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening questions - to verify the participant's basic information and current health plan status and validate their current or recent use of sMRA therapy (time frame: Up to 12 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023; AzTrials last refreshed its copy on 30 Oct 2026.