check_circleStudy Completed

Chronic Kidney Disease, Diabetes Mellitus, Type 2

Bayer Identifier:
22030
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
BAY94-8862, no drug Finerenone related - OS

Trial purpose

Patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) face high risks of kidney failure, cardiovascular disease and death. In recent years, new treatment classes (for example, SGLT2 inhibitors and GLP‑1 receptor agonists) have been introduced alongside established approaches such as ACE inhibitors/ARBs and steroidal MRAs. Finerenone, a selective non‑steroidal MRA, has also been approved in several regions for adults with CKD associated with T2D. To understand the real‑world landscape prior to and around the introduction of finerenone, FIRST‑1 will describe how often key cardiovascular events and kidney failure occur in adults with CKD and T2D who newly start commonly used medication classes. This is a multi‑database, multinational, non‑interventional cohort study using secondary data from Denmark (national health registers), Spain (Valencia Health System Integrated Database), the United Kingdom (Clinical Practice Research Datalink), the United States (Optum EHR), and Japan (J‑CKD‑DB‑Ex). Separate new‑user cohorts will be formed for initiators of SGLT2 inhibitors, GLP‑1 receptor agonists, steroidal MRAs, non‑steroidal MRAs (Japan only), and ACEi/ARB. Adults (≥18 years) with both CKD and T2D at cohort entry and at least 12 months of prior data are eligible; individuals with type 1 diabetes, kidney failure, or kidney cancer at baseline are excluded. Follow‑up begins the day after the index prescription and continues until treatment discontinuation, end of data, death, or development of kidney failure (for non‑kidney outcomes). Primary outcomes are acute coronary syndrome, stroke, new‑onset heart failure, new‑onset atrial fibrillation, and onset of kidney failure. Secondary endpoints include healthcare utilization (hospitalizations, emergency and specialist visits, and GP visits where available) and trajectories of kidney function measures (eGFR, albumin‑creatinine ratio) and serum potassium over time. Analyses are descriptive; incidences and mean cumulative counts will be estimated while accounting for competing risks. Results aim to provide contemporary background rates and kidney function patterns among patients with CKD and T2D initiating these therapies across multiple healthcare systems.

Key Participants Requirements

Sex

All

Age

18 Years
    - Have active registration or continuous enrolment in each respective data source for at least 12 months before the index date
    - Have no recorded prescription for any medication in that class during the 12 months before the index date
    - Be aged 18 years or older on the index date
    - Have a diagnosis of T2D identified by appropriate algorithms recorded on or ever before the index date
    - Have evidence of CKD (either by diagnosis or laboratory test) recorded on or ever before the index date
    - Have a diagnosis of T1D identified by appropriate algorithms in each data source on or ever before the index date
    - Have a diagnosis of kidney cancer on or ever before the index date
    - Fulfil an algorithm for kidney failure on or ever before the index date

Trial summary

Enrollment Goal
89144701
Trial Dates
October 2022 - March 2025
Phase
N/A
Could I Receive a placebo
N/A
Products
Unspecified
Accepts Healthy Volunteer
No

Primary Outcome

  • Acute Coronary Syndrome
    inpatient diagnosis of fatal or non‑fatal acute myocardial infarction or unstable angina (patients with ACS in prior 365 days excluded from this analysis).
    date_rangeTime Frame:
    from day after index prescription to end of follow‑up
  • Stroke
    inpatient diagnosis of fatal or non‑fatal stroke (ischaemic, haemorrhagic, or unspecified; patients with prior stroke in 365 days excluded)
    date_rangeTime Frame:
    from day after index prescription to end of follow‑up
  • New‑onset Heart Failure
    inpatient or emergency diagnosis of heart failure (patients with prior HF excluded).
    date_rangeTime Frame:
    from day after index prescription to end of follow‑up
  • New‑onset Atrial Fibrillation
    inpatient, emergency, or non‑hospital diagnosis of AF (patients with prior AF excluded).
    date_rangeTime Frame:
    from day after index prescription to end of follow‑up
  • Kidney Failure
    first of ≥2 eGFR <15 mL/min/1.73m² ≥90 days apart, chronic dialysis, diagnosis of kidney failure/CKD stage 5, or kidney transplant.
    date_rangeTime Frame:
    from day after index prescription to end of follow‑up

Secondary Outcome

  • Healthcare Utilization
    counts of inpatient admissions, emergency visits, specialist and GP visits (where available).
    date_rangeTime Frame:
    from day after index prescription to end of follow‑up
  • Kidney Function Measures
    GFR, ACR, and serum potassium trajectories; additional endpoints include ≥40% and ≥57% eGFR decline and serum potassium >5.5 or >6.0 mmol/L where feasible
    date_rangeTime Frame:
    baseline and repeated during follow‑up

Trial design

FIRST-1: Finerenone FIRST (Finerenone Research of Early Safety and Effectiveness), Part 1
Trial Type
Observational
Intervention Type
N/A
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A