Clinical trial NCT05526157: An Observational Study, Called FINEGUST, to Learn More About How People With Chronic Kidney Disease and Type 2 Diabetes Are Treated and How the Introduction of New Treatment Options, Like Finerenone, Impacts Clinical Practice
Official title: FINErenone druG Utilization Study and Assessment of Temporal Changes Following Availability of Different Treatment Options in Patients With Chronic Kidney Disease and Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Type 2 Diabetes Mellitus
Keywords: Chronic kidney disease
Type 2 diabetes mellitus
Impaired kidney function
Non-steroidal mineralocorticoid receptor antagonist (nsMRA)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2022-09-02
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: The study will be conducted using data from data sources in 5 countries: Denmark (the Danish National Health Registers), Japan (the Japan Chronic Kidney Disease Database), the Netherlands (PHARMO), Spain (the Valencia Health System Integrated Database), and the US (Optum). For each database, the source population will include patients who fulfil an electronic algorithm for CKD and T2D.

Brief summary: This is an observational study in which data from people with chronic kidney disease (CKD) and type 2 diabetes (T2D) who have already started or will start CKD or T2D treatment are collected and studied. In observational studies, only observations are made without specified advice or interventions.

People receiving the following CKD or T2D treatments as recommended by their doctors will be included:

* Sodium-glucose cotransporter 2 inhibitors (SGLT2i),
* Glucagon-like peptide-1 receptor agonists (GLP-1 RA),
* Steroidal mineralocorticoid receptor antagonists (sMRA),
* Finerenone, a non-steroidal mineralocorticoid receptor antagonist (nsMRA)
* Other nsMRA (only in Japan)

Kidneys filter extra water and waste from the blood and make urine. CKD is a long-term, progressive decrease in the kidneys' ability to properly filter blood. In people with T2D, the body does not make enough of a hormone called insulin or does not use insulin well enough, resulting in high blood sugar levels that can cause damage to the kidneys. As a result, CKD can occur as a complication of T2D.

The new drug, finerenone, works by blocking certain proteins, called mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys. By lowering their stimulation, finerenone reduces the risk of progressive worsening of the kidney disease.

Finerenone is available and approved in several countries for doctors to prescribe to people with CKD and T2D.

The main purpose of the study is to collect and describe characteristics of participants in each treatment group who have started or will start treatment before and after finerenone became available.

To do this, the researchers will collect data on:

* Patient characteristics (e.g., age sex) of the participants
* Clinical characteristics (e.g., history of CKD and T2D, heart and liver health, other health problems) of the participants
* Treatments for T2D and CKD
* Other medications used

Data will be grouped by type of treatment that is initiated (e.g., SGLT2i, a GLP-1 RA, a sMRA, finerenone, or other nsMRA). Two time periods will be compared. Study period I is the time until finerenone became available in the respective country, starting from 2012 (2014 for Japan). Study period II will begin when finerenone becomes available in the respective country and will end at the end of the study (planned in September 2024).

Researchers will also collect data on treatment patterns and changes for each type of treatment in both time periods.

Health care data will be collected from various sources in five countries (e.g., Denmark, the Netherlands, Spain, Japan, and the US).

The patients will receive their treatment as prescribed by their doctors during routine practice according to the approved product information.

Each patient will be in the study from first use (in Study period I and II) of one of the listed drug classes until:

* End of study
* The data are somehow no longer available
* The patient leaves or has to leave the study


Eligibility criteria: Inclusion Criteria:

* Active registration or continuous enrolment for at least 12 months in 1 of the selected data sources before the index date
* No recorded prescription or dispensing of any medication in the class during the 12 months before the index date
* Age 18 years or older as of the index date
* Diagnosis of T2D on or before the index date
* Diagnosis of CKD on or before the index date

Exclusion Criteria:

* Type 1 diabetes identified by appropriate algorithms in each participating data source
* Kidney cancer on or before the index date
* Kidney failure

  -- Maintenance dialysis on or before the index date
* Kidney transplantation on or before the index date

Primary outcomes:
measure: Descriptive summary of baseline patient characteristics
timeFrame: Baseline study periods I and II
measure: Descriptive summary of patient comorbidities
timeFrame: Baseline study periods I and II
measure: Descriptive summary of patient comedications
timeFrame: Baseline study periods I and II
Secondary outcomes:
measure: Descriptive summary of changes over time in treatments in the new-user cohorts
timeFrame: From Day 1 until Censor Day (at the earliest of death, disenrolment, exclusion criteria during follow-up, or end of the study period) [up to 114 months for study period I and up to 39 months for study period II].
measure: Descriptive summary of temporal changes in the baseline characteristics of medication-specific cohorts
timeFrame: Baseline up to 114 months for study period I and up to 39 months for study period II
Other outcomes:
Locations:
city: Eden Prairie
country: United States
facility: Optum CDM
state: Minnesota
city: Multiple Locations
country: Denmark
facility: Many Locations
city: Multiple Locations
country: Japan
facility: Many Locations
city: Multiple Locations
country: Netherlands
facility: Many Locations
city: Multiple Locations
country: Spain
facility: Many Locations
Study officials:
References: