Clinical trial NCT06278207: 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
Official title: Finerenone Research of Outcomes and Drug Utilization
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Disease
Type 2 Diabetes Mellitus
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2024-02-26
Enrollment: 50000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with chronic kidney disease and type 2 diabetes who initiate finerenone in secondary data sources (electronic health records (EHR) and claims data) in the United States and in Japan.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

- 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

Primary outcomes:
measure: Participants' characteristics at baseline in a cohort of participants with CKD and T2D who initiate finerenone.
timeFrame: 12 months before first prescription/dispensation of finerenone (index date)
measure: Participants' comorbidities at baseline in a cohort of participants with CKD and T2D who initiate finerenone.
timeFrame: 12 months before first prescription/dispensation of finerenone (index date)
measure: Participants' comedications at baseline in a cohort of participants with CKD and T2D who initiate finerenone.
timeFrame: 12 months before first prescription/dispensation of finerenone (index date)
Secondary outcomes:
measure: Proportion of finerenone initiators with and without UACR measurements at baseline
timeFrame: From first prescription/dispensation of finerenone (index date) until 12 months after index date
measure: Average UACR in the subcohort with UACR measurements
timeFrame: From first prescription/dispensation of finerenone (index date) until 12 months after index date
measure: Incidence rate of kidney failure in participants with CKD and T2D that initiate finerenone.
timeFrame: 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
measure: Incidence rate of a composite cardiovascular outcome in participants with CKD and T2D that initiate finerenone.
timeFrame: 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
measure: Drug utilization patterns in a cohort of participants with CKD and T2D that initiate finerenone.
timeFrame: 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
measure: Number of participants who initiate finerenone at a 10 mg dose daily
timeFrame: At day 0 (first prescription/dispensation of finerenone)
measure: Proportion of participants who continue the original 10 mg dose daily at the 1, 3, 6, and 12 months mark
timeFrame: From first prescription/dispensation of finerenone (index date) until 12 months after index date
measure: 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
timeFrame: From first prescription/dispensation of finerenone (index date) until 12 months after index date
measure: Number of participants who initiate finerenone at a 20 mg dose daily
timeFrame: At day 0 (first prescription/dispensation of finerenone)
measure: Proportion of participants who continue the original 20 mg dose daily at the 1, 3, 6, and 12 months mark
timeFrame: From first prescription/dispensation of finerenone (index date) until 12 months after index date
measure: 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
timeFrame: From first prescription/dispensation of finerenone (index date) until 12 months after index date
Other outcomes:
Locations:
city: Multiple Locations
country: United States
facility: Many Locations
state: New Jersey
city: Berlin
country: Germany
facility: Bayer
city: Multiple Locations
country: Japan
facility: Many Locations
Study officials:
References: