An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice

Launched by BAYER · Jan 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a medication called finerenone in people from India who have both chronic kidney disease (CKD) and type 2 diabetes. The goal is to understand how well this medication works in everyday medical practice for patients who have just started taking it. To participate, individuals must be 18 years or older, have been diagnosed with CKD and type 2 diabetes before starting finerenone, and must be starting this medication for the first time between August 1, 2022, and April 30, 2024.

Participants in the trial will be closely monitored to assess their health and how finerenone affects their condition. However, some people won't be able to join the study, such as those with very low kidney function, high potassium levels, or certain other health issues. It's important to note that this study is observational, meaning that researchers will observe and collect data without changing participants’ usual treatment plans. If you or someone you know fits the eligibility criteria and is interested in learning more about this trial, please reach out to a healthcare provider for further information.

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Eligibility criteria

• Inclusion Criteria:
• • Patients from India (Indian ethnicity) diagnosed with CKD and T2D prior to initiating finerenone (per the standard diagnostic criteria) and initiated on finerenone per approved label.
• • Patient was prescribed finerenone for the first time (drug naïve) for the management of CKD and T2D between 1st August 2022 and 30th April 2024.
• • Age 18 years or older at the time of finerenone initiation.
• Exclusion Criteria:
• • eGFR \<25 mL/min/1.73 m\^2
• • Serum potassium \>5.0 mmol/L
• • Type 1 diabetes is recorded in the patient record
• * Contraindications according to the local marketing authorization - Patient data will be excluded if below information is identified in the patient record at any point from index date to the end of observation period:
• • - Pregnancy.
• • - Lactation.
• • - Patient taking concomitant medications that are strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin and nefazodone).
• • - Addison's disease.
• • Patient was a part of an interventional clinical study between 1st August 2022 and 30th Nov 2024.