pause_circle_filledNot Yet Recruiting

Chronic kidney disease, Type 2 diabetes mellitus

Bayer Identifier:

22549

ClinicalTrials.gov Identifier:

NCT06763146

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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.
  • - 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.

Trial summary

Enrollment Goal
1200
Trial Dates
June 2025 - December 2025
Phase
Phase 4
Could I Receive a placebo
No
Products
Kerendia (Finerenone, BAY94-8862)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Not yet recruiting
Many locationsMany locations, India

Primary Outcome

  • Descriptive summary of specialty of prescribing physician
    date_rangeTime Frame:
    Retrospective data analysis from 2022 to 2024
  • Date of finerenone initiation
    date_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 finerenone
    date_rangeTime Frame:
    Retrospective data analysis from 2022 to 2024
  • Reason for discontinuation of finerenone
    date_rangeTime Frame:
    Retrospective data analysis from 2022 to 2024
  • Dose of finerenone treatment
    date_rangeTime Frame:
    Retrospective data analysis from 2022 to 2024
  • Frequency of finerenone treatment
    date_rangeTime Frame:
    Retrospective data analysis from 2022 to 2024
  • The number of patients who initiated finerenone with a 10-mg dose and 20-mg dose
    date_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 dose
    date_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 dose
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    Retrospective data analysis from 2022 to 2024

Secondary Outcome

  • UACR (mg/g) before and after initiating finerenone
    UACR: Urine Albumin to Creatinine Ratio
    date_rangeTime Frame:
    Retrospective data analysis from Aug 2022 to Apr 2024
  • eGFR before and after initiating finerenone
    eGFR: Estimated glomerular filtration rate
    date_rangeTime Frame:
    Retrospective data analysis from Aug 2022 to Apr 2024
  • Serum potassium (mmol/L) before and after initiating finerenone
    date_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 study
    date_rangeTime Frame:
    Retrospective data analysis from 2022 to 2024
  • Change in serum potassium after initiating finerenone vs month 1, month 4 and end of study
    date_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 study
    date_rangeTime Frame:
    Retrospective data analysis from Aug 2022 to Apr 2024
  • Frequency of events like hospitalization and dialysis due to hyperkalemia
    date_rangeTime Frame:
    Retrospective data analysis from Aug 2022 to Apr 2024

Trial design

Real-world experience with finerenone treatment in patients from India with chronic kidney disease and type 2 diabetes–Retrospective data analysis
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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