pause_circle_filledNot Yet Recruiting
Chronic kidney disease, Type 2 diabetes mellitus
Bayer Identifier:
22549
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial purpose
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.
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 Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
1200Trial Dates
June 2025 - December 2025Phase
Phase 4Could I Receive a placebo
NoProducts
Kerendia (Finerenone, BAY94-8862)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Not yet recruiting | Many locations | Many locations, India |
Primary Outcome
- Descriptive summary of specialty of prescribing physiciandate_rangeTime Frame:Retrospective data analysis from 2022 to 2024
- Date of finerenone initiationdate_rangeTime Frame:Retrospective data analysis from 2022 to 2024
- If patient was receiving finerenone at the time of each follow-up visit (Yes/No)date_rangeTime Frame:Retrospective data analysis from 2022 to 2024
- Date of discontinuation of finerenonedate_rangeTime Frame:Retrospective data analysis from 2022 to 2024
- Reason for discontinuation of finerenonedate_rangeTime Frame:Retrospective data analysis from 2022 to 2024
- Dose of finerenone treatmentdate_rangeTime Frame:Retrospective data analysis from 2022 to 2024
- Frequency of finerenone treatmentdate_rangeTime Frame:Retrospective data analysis from 2022 to 2024
- The number of patients who initiated finerenone with a 10-mg dose and 20-mg dosedate_rangeTime Frame: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 dosedate_rangeTime Frame: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 dosedate_rangeTime Frame:Retrospective data analysis from 2022 to 2024
- Actions taken after finerenone introductionActions include continue treatment, addition of second therapy like SGLT2is, potassium binders, discontinue treatmentdate_rangeTime Frame:Retrospective data analysis from 2022 to 2024
- Actions taken after stop finerenone prescriptionActions include initiate alternate therapy like Sodium-glucose transport protein-2 inhibitor (SGLT2is), RAASis or potassium binders, otherdate_rangeTime Frame:Retrospective data analysis from 2022 to 2024
Secondary Outcome
- UACR (mg/g) before and after initiating finerenoneUACR: Urine Albumin to Creatinine Ratiodate_rangeTime Frame:Retrospective data analysis from Aug 2022 to Apr 2024
- eGFR before and after initiating finerenoneeGFR: Estimated glomerular filtration ratedate_rangeTime Frame:Retrospective data analysis from Aug 2022 to Apr 2024
- Serum potassium (mmol/L) before and after initiating finerenonedate_rangeTime Frame:Retrospective data analysis from Aug 2022 to Apr 2024
- Change in UACR after initiating finerenone vs month 1, month 4 and end of studydate_rangeTime Frame:Retrospective data analysis from 2022 to 2024
- Change in serum potassium after initiating finerenone vs month 1, month 4 and end of studydate_rangeTime Frame: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 studydate_rangeTime Frame:Retrospective data analysis from Aug 2022 to Apr 2024
- Frequency of events like hospitalization and dialysis due to hyperkalemiadate_rangeTime Frame:Retrospective data analysis from Aug 2022 to Apr 2024
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A