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Chronic Kidney DiseaseFIRST-2NCT05703880

An Observational Study Called FIRST-2.0 to Learn More About the Use of the Study Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions

An observational study of Chronic Kidney Disease and Type 2 Diabetes Mellitus, run by Bayer at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Finerenone (Kerendia, BAY948862)
How many people
15,948 participants
Where
2 sitesUnited States
Study dates
1 Jun 2023to 1 Oct 2024
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: 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.

Who may be able to join

  • Minimum of 12 months continuous enrolment in the EHR databases with medical and pharmacy coverage measured as continuously receiving medical care from health providers contributing to the EHR system.
  • No recorded prescription of finerenone prior to the index date.
  • Age 18 years or older as of the index date.
  • T2D diagnosis at any point before (and including) the index date using the same algorithms applicable to the specific data source as in previous studies of the FIRST program.
  • 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:
  • A diagnosis code indicating CKD stage 2, 3, 4, or stage unspecified OR
  • Two Urinary Albumin-to-Creatinine Ratio (ACR) test results ≥ 30 mg/g separated by at least 90 days and no more than 540 days OR
  • Two different eGFR test results ≥ 15 mL/min/1.73 m*2 AND < 60 mL/min/1.73 m*2 separated by at least 90 days and no more than 540 days.

Who cannot join

  • Type 1 diabetes identified by appropriate algorithms in the data source
  • Kidney cancer on or before the index date
  • Kidney failure defined as:
  • Two different eGFR test results < 15 mL/min/1.73 m*2 separated by at least 90 days and no more than 540 days
  • Dependence on dialysis (at least 3 sessions over at least 90 days during the baseline period)
  • A diagnosis code indicating kidney failure or CKD stage 5 (International Classification of Diseases, 10th Revision)
  • Kidney transplant

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • OM1 Real-World Data Cloud (RWDC)

    Boston, Massachusetts, 02116

  • Optum electronic health records (EHR) database

    Eden Prairie, Minnesota, 55344

Other trials in United States

About this study

Official title: Finerenone FIRST (Finerenone Research of Early Safety and Effectiveness), Part 2.0

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.

Read more

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:

  • general information of the participants such as age or gender
  • any other disease or medical condition in the participants
  • other medications used while taking finerenone.

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.

Being tested
Finerenone (Kerendia, BAY948862)
Medical subject headings
Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Finerenone (Kerendia, BAY948862)Drug

    Retrospective cohort analysis using United States Optum EHR data and OM1 RWDC databases.

Study groups in NCT05703880
Study groupRoleWhat they receive
Finerenone (Kerendia, BAY948862)Adults with CKD and T2D from the USA who initiate finerenone.
Receives: Drug: Finerenone (Kerendia, BAY948862)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Descriptive summary of characteristics of patients who initiate finerenone and have CKD and T2D in the US.

    Measured: Up to 365 days

  2. Descriptive summary of comorbidities of patients who initiate finerenone and have CKD and T2D in the US.

    Measured: Up to 365 days

  3. Descriptive summary of comedications of patients who initiate finerenone and have CKD and T2D in the US.

    Measured: Up to 180 days

Secondary outcomes (11)

  1. Incidence rate of composite renal outcomes

    Measured: Up to 18 months

  2. Incidence rate of composite cardiovascular outcomes

    Measured: Up to 18 months

  3. 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.

    Measured: Up to 18 months

  4. 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

    Measured: Up to 18 months

  5. Incidence rate of hyperkalemia

    Measured: Up to 18 months

  6. Incidence of hospitalization associated with a hyperkalemia event

    Measured: Up to 18 months

  7. Change in UACR between baseline, at 4 months and end of follow up visit after initiating finerenone

    UACR: Urine Albumin to Creatinine Ratio

    Measured: Up to 18 months

  8. Change in eGFR between baseline, at 4 months and end of follow up visit after initiating finerenone

    eGFR: Estimated Glomerular Filtration Rate

    Measured: Up to 18 months

  9. Change in level of serum potassium between baseline and end of follow up visit after initiating finerenone

    Measured: Up to 18 months

  10. Incidence rates of the respective component outcomes of the CV and renal composite outcomes

    Measured: Up to 18 months

  11. 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.

    Measured: Up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2023
  2. Study start1 Jun 2023
  3. Primary completion1 Oct 2024
  4. Study completion1 Oct 2024

Resources

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
Retrospective
Enrolment
15,948 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05703880
Sponsor's protocol ID
22381
Acronym
FIRST-2
Status last verified
Oct 2024
First submitted
20 Jan 2023
Last updated
18 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
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.

Publications

  • Vizcaya D, Kovesdy CP, Reyes A, Pessina E, Pujol P, James G, Oberprieler NG. Characteristics of patients with chronic kidney disease and Type 2 diabetes initiating finerenone in the USA: a multi-database, cross-sectional study. J Comp Eff Res. 2023 Aug;12(8):e230076. doi: 10.57264/cer-2023-0076. Epub 2023 Jun 30.

    PubMed 37387399

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 2 sites 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 8 inclusion and 7 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 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Descriptive summary of characteristics of patients who initiate finerenone and have CKD and T2D in the US. (time frame: Up to 365 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05703880, which also lists 1 linked publication.

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 18 Oct 2024.

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