check_circleStudy Completed

Chronic kidney disease, Type 2 diabetes mellitus

Bayer Identifier:

22381

ClinicalTrials.gov Identifier:

NCT05703880

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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.

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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.
  • - 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 summary

Enrollment Goal
15948
Trial Dates
June 2023 - October 2024
Phase
Phase 4
Could I Receive a placebo
No
Products
Kerendia (Finerenone, BAY94-8862)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Optum electronic health records (EHR) databaseEden Prairie, 55344, United States
Completed
OM1 Real-World Data Cloud (RWDC)Boston, 02116, United States

Primary Outcome

  • Descriptive summary of characteristics of patients who initiate finerenone and have CKD and T2D in the US.
    date_rangeTime Frame:
    Up to 365 days
  • Descriptive summary of comorbidities of patients who initiate finerenone and have CKD and T2D in the US.
    date_rangeTime Frame:
    Up to 365 days
  • Descriptive summary of comedications of patients who initiate finerenone and have CKD and T2D in the US.
    date_rangeTime Frame:
    Up to 180 days

Secondary Outcome

  • Incidence rate of composite renal outcomes
    date_rangeTime Frame:
    Up to 18 months
  • Incidence rate of composite cardiovascular outcomes
    date_rangeTime Frame:
    Up to 18 months
  • 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.
    date_rangeTime Frame:
    Up to 18 months
  • 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
    date_rangeTime Frame:
    Up to 18 months
  • Incidence rate of hyperkalemia
    date_rangeTime Frame:
    Up to 18 months
  • Incidence of hospitalization associated with a hyperkalemia event
    date_rangeTime Frame:
    Up to 18 months
  • Change in UACR between baseline, at 4 months and end of follow up visit after initiating finerenone
    UACR: Urine Albumin to Creatinine Ratio
    date_rangeTime Frame:
    Up to 18 months
  • Change in eGFR between baseline, at 4 months and end of follow up visit after initiating finerenone
    eGFR: Estimated Glomerular Filtration Rate
    date_rangeTime Frame:
    Up to 18 months
  • Change in level of serum potassium between baseline and end of follow up visit after initiating finerenone
    date_rangeTime Frame:
    Up to 18 months
  • Incidence rates of the respective component outcomes of the CV and renal composite outcomes
    date_rangeTime Frame:
    Up to 18 months
  • 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.
    date_rangeTime Frame:
    Up to 18 months

Trial design

Finerenone FIRST (Finerenone Research of Early Safety and Effectiveness), Part 2.0
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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