account_circleRecruiting

Chronic kidney disease, Type 2 diabetes mellitus

Bayer Identifier:

22731

ClinicalTrials.gov Identifier:

NCT06278207

EudraCT Number:

Not Available

EU CT Number:

Not Available
An observational study called FINEROD to learn more about the use of the 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 Japan and in the United States 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 initiate finerenone treatment as prescribed by their doctors. To do this, the researchers will collect general information of the participants such as age or gender and data on kidney function and possible heart problems.
The researchers will also collect data on any other disease or medical condition in the participants and on other medications used while taking finerenone.
The data will come from a network of commercial electronic health records (EHRs) and national claims data in the United States and in Japan. They cover the period from July 1st, 2021 until March 2024. 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
  • - A minimum of 12 months of continuous enrolment in the databases with medical and pharmacy coverage measured as continuously receiving medical care from health providers contributing to the EHR or claims system, depending on the database used
    - No recorded prescription for finerenone in the 12 months prior to the index date
    - Age of 18 years or older as of the index date
    - Evidence of T2D at any point before (and including) the index date.
    - 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
     -- two UACR tests results ≥ 30 mg/g separated by at least 90 days and by not more than 540 days
     -- two different eGFR test results ≥ 15 mL/min/1.73 m2 AND < 60 mL/min/1.73 m2 separated by at least 90 days and by not more than 540 days
  • - Kidney failure defined as follows:
     -- Two different eGFR test results < 15 mL/min/1.73 m2 separated by at least 90 days and by not 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; Kidney transplant

Trial summary

Enrollment Goal
50000
Trial Dates
May 2024 - October 2025
Phase
N/A
Could I Receive a placebo
No
Products
Kerendia (Finerenone, BAY94-8862)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
BayerBerlin, 13353, Germany
Completed
Many LocationsMany Locations, Japan
Completed
Many LocationsMany Locations, 07981, United States

Primary Outcome

  • Participants’ characteristics at baseline in a cohort of participants with CKD and T2D who initiate finerenone.
    Sociodemographic characteristics such as age, sex, race and socio-economic status.
    date_rangeTime Frame:
    12 months before first prescription/dispensation of finerenone (index date)
  • Participants’ comorbidities at baseline in a cohort of participants with CKD and T2D who initiate finerenone.
    Including heart diseases, lipid diseases, liver disease, hospitalization for acute kidney injury, dementia, body mass index, smoking status, alcohol abuse, and other comorbidities measured using comorbidities indexes (such as the Charlson comorbidity index)
    date_rangeTime Frame:
    12 months before first prescription/dispensation of finerenone (index date)
  • Participants’ comedications at baseline in a cohort of participants with CKD and T2D who initiate finerenone.
    In subcohorts of participants in co-medication between finerenone and other hypertensive and diabetic medications (SGLT2i, RAASi, GLP-1 RA, etc.), characterized by CKD stage
    date_rangeTime Frame:
    12 months before first prescription/dispensation of finerenone (index date)

Secondary Outcome

  • Proportion of finerenone initiators with and without UACR measurements at baseline
    UACR=Urinary Albumin-to-Creatinine Ratio
    date_rangeTime Frame:
    From first prescription/dispensation of finerenone (index date) until 12 months after index date
  • Average UACR in the subcohort with UACR measurements
    date_rangeTime Frame:
    From first prescription/dispensation of finerenone (index date) until 12 months after index date
  • Incidence rate of kidney failure in participants with CKD and T2D that initiate finerenone.
    Any of the following: ≥ 2 outpatient eGFR measurements of < 15 mL/min/1.73 m2 separated by at least 90 days; Record of dependence on dialysis (at least 3 sessions over at least 90 days); Diagnosis records of kidney failure or CKD stage 5; Record of kidney transplant
    date_rangeTime Frame:
    From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months
  • Incidence rate of a composite cardiovascular outcome in participants with CKD and T2D that initiate finerenone.
    Acute myocardial infarction, identified as an inpatient hospital diagnosis of fatal or non-fatal acute myocardial infarction. Congestive heart failure, identified as an impatient hospital or emergency department diagnosis of heart failure and stratified by new-onset or recurrent heart failure.
    date_rangeTime Frame:
    From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months
  • Drug utilization patterns in a cohort of participants with CKD and T2D that initiate finerenone.
    Depending on the database used, this includes incidence of drug use, initiation of treatment measured by drug prescription, drug dispensation, or a combination of both depending on data availability, dosing regimen, treatment persistence and non-persistence, and implementation measured as the proportion of days covered.
    date_rangeTime Frame:
    From first prescription/dispensation of finerenone (index date) until end of follow-up (death, disenrollment, development of either kidney failure or kidney cancer, or by the last available date in the corresponding database) up to 150 months
  • Number of participants who initiate finerenone at a 10 mg dose daily
    date_rangeTime Frame:
    At day 0 (first prescription/dispensation of finerenone)
  • Proportion of participants who continue the original 10 mg dose daily at the 1, 3, 6, and 12 months mark
    date_rangeTime Frame:
    From first prescription/dispensation of finerenone (index date) until 12 months after index date
  • Proportion of participants who up-titrate from 10 mg daily dose to a 20 mg dose daily at the 1, 3, 6, and 12 months mark
    date_rangeTime Frame:
    From first prescription/dispensation of finerenone (index date) until 12 months after index date
  • Number of participants who initiate finerenone at a 20 mg dose daily
    date_rangeTime Frame:
    At day 0 (first prescription/dispensation of finerenone)
  • Proportion of participants who continue the original 20 mg dose daily at the 1, 3, 6, and 12 months mark
    date_rangeTime Frame:
    From first prescription/dispensation of finerenone (index date) until 12 months after index date
  • Proportion of participants who down-titrate from 20 mg daily dose to a 10 mg dose daily at the 1, 3, 6, and 12 months mark
    date_rangeTime Frame:
    From first prescription/dispensation of finerenone (index date) until 12 months after index date

Trial design

Finerenone Research of Outcomes and Drug Utilization
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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