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Clinical Trial Details

Trial ID: L1122
Source ID: NCT06763146
Associated Drug: Finerenone (Kerendia, Bay948862)
Title: 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
Acronym: IN-REALITY
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Disease|Type 2 Diabetes Mellitus
Interventions: DRUG: Finerenone (Kerendia, BAY948862)
Outcome Measures: Primary: 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: UACR (mg/g) before and after initiating finerenone, UACR: Urine Albumin to Creatinine Ratio, Retrospective data analysis from Aug 2022 to Apr 2024|eGFR before and after initiating finerenone, eGFR: Estimated glomerular filtration rate, 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|Change in Serum creatinine/eGFR after initiating finerenone vs month 1, month 4 and end of study, Retrospective data analysis from Aug 2022 to Apr 2024|Frequency of events like hospitalization and dialysis due to hyperkalemia, Retrospective data analysis from Aug 2022 to Apr 2024
Sponsor/Collaborators: Sponsor: Bayer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 1200
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2025-06-02
Completion Date: 2025-12-01
Results First Posted:
Last Update Posted: 2025-04-23
Locations: Many locations, Multiple Locations, India
URL: https://clinicaltrials.gov/show/NCT06763146