check_circleStudy Completed

Bayer Identifier:
22487
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
BAY 948862, Finerenone > BAY94-8862, no drug Finerenone related - OS

Trial purpose

This study is focused on understanding how certain medications can help patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) in China. The main goal is to see how often serious heart problems and kidney failure occur in patients starting treatment with specific types of medicines.

We will collect information from a large healthcare database that includes data from many hospitals in Tianjin, China. The study will look at patients who began using these medications between January 1, 2012, and December 31, 2019. By analyzing this data, we hope to learn more about how effective these treatments are and how they affect patients' health over time.

The findings from this study could help improve treatment options for people with CKD and T2D, ultimately leading to better health outcomes for these patients. We want to ensure that patients receive the best care possible, and this research will provide valuable insights into the effectiveness of existing treatments.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • -
  • -

Trial summary

Enrollment Goal
20000
Trial Dates
December 2023 - July 2024
Phase
Phase 4
Could I Receive a placebo
N/A
Products
Unspecified
Accepts Healthy Volunteer
No

Primary Outcome

  • To describe rates of cardiovascular events and kidney failure in patients with CKD and T2D in the following non-mutually exclusive, treatment-based cohorts: Patients initiating SGLT2i, Patients initiating GLP-1 RA, Patients initiating sMRA, • Patients initiating ACEi or ARB (medications considered together as a single class)
    This outcome includes major cardiovascular events such as acute coronary syndrome (including myocardial infarction and unstable angina), stroke, new-onset congestive heart failure, and new-onset atrial fibrillation.
    date_rangeTime Frame:
    Follow-up begins the day after the index date and continues until the occurrence of the event or censoring criteria are met.

Secondary Outcome

  • Describe healthcare resource utilisation in the study cohorts of patients with CKD and T2D
    This outcome includes counts of healthcare encounters such as inpatient hospital admissions, emergency department visits, specialist visits, and general practitioner visits.
    date_rangeTime Frame:
    Follow-up begins the day after the index date and continues throughout the study period
  • Describe the absolute levels and relative change over time of the following measures of kidney function in the study cohorts of patients with CKD and T2D
    Laboratory measures of kidney function will be tracked, including estimated glomerular filtration rate (eGFR), urine albumin-to-creatinine ratio (ACR), and serum potassium levels, to evaluate changes over time.
    date_rangeTime Frame:
    Baseline and during follow-up, with assessments at various time points post-treatment initiation.

Trial design

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

Additional Information

​Click here for access to information about Bayer’s transparency standards and Bayer studies.Study_Synopsis-22487.docx attachment has been generated from the Study Synopsis template. Data may be populated from the following (as available) : Study (7.0), Protocol (0.2), Results(0.1)