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Clinical Trials in India / NCT06763146
Active, not recruiting Observational

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 · tracked via the Priya Life Science India tracker
Sponsor
Bayer
Phase
Observational
Started
2025-09-22
Last updated
2026-10-14

Condition(s) studied

Chronic Kidney DiseaseType 2 Diabetes Mellitus

Investigational drug(s) / intervention(s)

Finerenone (Kerendia, BAY948862) →

Finerenone (Kerendia, BAY948862): 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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 — Retrospective data analysis from 2022 to 2024
    Actions include continue treatment, addition of second therapy like SGLT2is, potassium binders, discontinue treatment
  • Actions taken after stop finerenone prescription — Retrospective data analysis from 2022 to 2024
    Actions include initiate alternate therapy like Sodium-glucose transport protein-2 inhibitor (SGLT2is), RAASis or potassium binders, other

Trial sites (1)

FacilityCityRegionStatus
Many locations Many Locations India

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A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria Active, not recruiting
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Other trials for the same condition

A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria Recruiting
A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus on Background Insulin Recruiting
A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus and Impaired Renal Function on Background Dapagliflozin Recruiting
Effectiveness of Subgingival Instrumentation on Delaying End-stage Renal Disease Among Chronic Kidney Disease Patients Starting soon
A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06763146 on ClinicalTrials.gov ↗ ← All trials in India