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

Sponsor
Bayer
Study ID
NCT06763146
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Finerenone (Kerendia, BAY948862) — DRUG
    Retrospective cohort analysis using the investigator or a delegate at the study site collects secondary/historic data of finerenone usage (patient demographic and clinical characteristics, diagnosis-related, treatment-related, and laboratory data) from clinic specific medical records.

Study Details

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Key Dates

Start date
Sep 22, 2025
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
1,200 participants (estimated)

Arms

  • Arm: Finerenone (Kerendia, BAY948862)
    Patients with CKD and T2D from India who initiate on finerenone per approved label.

Primary Outcome Measure

Descriptive summary of specialty of prescribing physician [ Time Frame: Retrospective data analysis from 2022 to 2024 ]

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