Trial Condition(s):

Chronic Kidney Disease, Type 2 Diabetes Mellitus

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 (IN-REALITY)

Bayer Identifier:

22549

ClinicalTrials.gov Identifier:

NCT06763146

EudraCT Number:

Not Available

EU CT Number:

Not Available

Not Yet Recruiting

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.

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.

Trial Summary

Enrollment Goal
1200
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Kerendia (Finerenone, BAY94-8862)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many locations

Many locations, India

Status
Not yet recruiting

Contact Us:

E-mail: [email protected]

Phone: (+)1-888-84 22937

Trial Design

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