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

NCT06763146 | Active Not Recruiting

• 1 other identifier: 22549
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Disease; Type 2 Diabetes Mellitus

Keywords

CKD; T2DM

Outcome Measures

Primary Outcomes (12)

• Descriptive summary of specialty of prescribing physician

  Retrospective data analysis from 2022 to 2024

• Date of finerenone initiation

  Retrospective data analysis from 2022 to 2024

• If patient was receiving finerenone at the time of each follow-up visit (Yes/No)

  Retrospective data analysis from 2022 to 2024

• Date of discontinuation of finerenone

  Retrospective data analysis from 2022 to 2024

• Reason for discontinuation of finerenone

  Retrospective data analysis from 2022 to 2024

• Dose of finerenone treatment

  Retrospective data analysis from 2022 to 2024

• Frequency of finerenone treatment

  Retrospective data analysis from 2022 to 2024

• The number of patients who initiated finerenone with a 10-mg dose and 20-mg dose

  Retrospective data analysis from 2022 to 2024

• The proportion of patients who initiated finerenone with a 10-mg dose and have up-titrated to a 20-mg dose

  Retrospective data analysis from 2022 to 2024

• The proportion of patients who initiated finerenone with a 20-mg dose and have down-titrated to a 10-mg dose

  Retrospective data analysis from 2022 to 2024

• Actions taken after finerenone introduction

  Actions include continue treatment, addition of second therapy like SGLT2is, potassium binders, discontinue treatment

  Retrospective data analysis from 2022 to 2024

• Actions taken after stop finerenone prescription

  Actions include initiate alternate therapy like Sodium-glucose transport protein-2 inhibitor (SGLT2is), RAASis or potassium binders, other

  Retrospective data analysis from 2022 to 2024

Secondary Outcomes (7)

• UACR (mg/g) before and after initiating finerenone

  Retrospective data analysis from Aug 2022 to Apr 2024

• eGFR before and after initiating finerenone

  Retrospective data analysis from Aug 2022 to Apr 2024

• Serum potassium (mmol/L) before and after initiating finerenone

  Retrospective data analysis from Aug 2022 to Apr 2024

• Change in UACR after initiating finerenone vs month 1, month 4 and end of study

  Retrospective data analysis from 2022 to 2024

• Change in serum potassium after initiating finerenone vs month 1, month 4 and end of study

  Retrospective data analysis from Aug 2022 to Apr 2024

Study Arms (1)

Finerenone (Kerendia, BAY948862)

Patients with CKD and T2D from India who initiate on finerenone per approved label.

Drug: Finerenone (Kerendia, BAY948862)

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.

Finerenone (Kerendia, BAY948862)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of CKD associated with T2D who are initiated on finerenone under routine clinical management.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many locations

Multiple Locations, India

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2

Interventions

finerenone

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 8, 2025
• Study Start: September 22, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)