Clinical trial NCT06763146: 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
Official title: Real-world Experience With Finerenone Treatment in Patients From India With Chronic Kidney Disease and Type 2 Diabetes-Retrospective Data Analysis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Kidney Disease
Type 2 Diabetes Mellitus
Keywords: CKD
T2DM
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2025-01-08
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of CKD associated with T2D who are initiated on finerenone under routine clinical management.

Brief 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.

Detailed description: This is an observational study in which data already collected from people with chronic kidney disease (CKD) and Type 2 diabetes mellitus (T2D) are studied.

T2D is a condition in which glucose levels rise in the blood. It is one of the common causes of CKD and can lead to kidney failure. CKD is a long-term condition in which the kidneys' ability to work properly gradually decreases over time.

The study drug, finerenone, is already approved for doctors to prescribe to people with CKD and T2D. It blocks the activity of a protein involved in worsening kidney function.

People with CKD and T2D are already receiving treatment with finerenone based on the results of previous studies. These studies, however, did not include Indian participants.

To better understand the impact of finerenone on CKD and T2D, more knowledge is needed about how well it works in the Indian population.

The main purpose of the study is to learn more about how well finerenone works and how safe it is in Indian people with CKD and T2D. To do this, researchers will check:

* participants' characteristics including age, sex, height and weight, and signs and symptoms of the disease
* other conditions the participants may have along with CKD and T2D, additional medicines they have taken with finerenone, and different treatment patterns in Indian participants.

The different treatment pattern for finerenone includes:

* specialty of the doctor who prescribed finerenone
* the date of starting finerenone
* whether participants were still taking finerenone at each follow-up visit
* the date and reason for stopping finerenone early
* the dose of finerenone the participants took and how often they took it
* changes in the dosage either with a low dose or high dose compared with the previous firenone dose
* after starting finerenone treatment: reseachers may ask to continue treatment with finerenone, or may suggest adding other treatments like SGLT2 inhibitors or potassium binders, or stop finerenone treatment
* after stopping finerenone treatment: researchers may start other treatments, like SGLT2 inhibitors, RAAS inhibitors, or potassium binders or other therapy

Researchers will only look at the medical records from participants in India. Data collected will be from August 2022 to April 2024.

Researchers will track participants' data in India and will follow them until the end of the study period till Nov 2024, last visit date of the participant, the participant discontinues treatment with finerenone, death, kidney failure, or cancer of the kidney.

In this study, only available data from routine care in India are collected. No visits or tests are required as part of this study.

Eligibility criteria: 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 outcomes:
measure: Descriptive summary of specialty of prescribing physician
timeFrame: Retrospective data analysis from 2022 to 2024
measure: Date of finerenone initiation
timeFrame: Retrospective data analysis from 2022 to 2024
measure: If patient was receiving finerenone at the time of each follow-up visit (Yes/No)
timeFrame: Retrospective data analysis from 2022 to 2024
measure: Date of discontinuation of finerenone
timeFrame: Retrospective data analysis from 2022 to 2024
measure: Reason for discontinuation of finerenone
timeFrame: Retrospective data analysis from 2022 to 2024
measure: Dose of finerenone treatment
timeFrame: Retrospective data analysis from 2022 to 2024
measure: Frequency of finerenone treatment
timeFrame: Retrospective data analysis from 2022 to 2024
measure: The number of patients who initiated finerenone with a 10-mg dose and 20-mg dose
timeFrame: Retrospective data analysis from 2022 to 2024
measure: The proportion of patients who initiated finerenone with a 10-mg dose and have up-titrated to a 20-mg dose
timeFrame: Retrospective data analysis from 2022 to 2024
measure: The proportion of patients who initiated finerenone with a 20-mg dose and have down-titrated to a 10-mg dose
timeFrame: Retrospective data analysis from 2022 to 2024
measure: Actions taken after finerenone introduction
timeFrame: Retrospective data analysis from 2022 to 2024
measure: Actions taken after stop finerenone prescription
timeFrame: Retrospective data analysis from 2022 to 2024
Secondary outcomes:
measure: UACR (mg/g) before and after initiating finerenone
timeFrame: Retrospective data analysis from Aug 2022 to Apr 2024
measure: eGFR before and after initiating finerenone
timeFrame: Retrospective data analysis from Aug 2022 to Apr 2024
measure: Serum potassium (mmol/L) before and after initiating finerenone
timeFrame: Retrospective data analysis from Aug 2022 to Apr 2024
measure: Change in UACR after initiating finerenone vs month 1, month 4 and end of study
timeFrame: Retrospective data analysis from 2022 to 2024
measure: Change in serum potassium after initiating finerenone vs month 1, month 4 and end of study
timeFrame: Retrospective data analysis from Aug 2022 to Apr 2024
measure: Change in Serum creatinine/eGFR after initiating finerenone vs month 1, month 4 and end of study
timeFrame: Retrospective data analysis from Aug 2022 to Apr 2024
measure: Frequency of events like hospitalization and dialysis due to hyperkalemia
timeFrame: Retrospective data analysis from Aug 2022 to Apr 2024
Other outcomes:
Locations:
city: Multiple Locations
country: India
facility: Many locations
Study officials:
References: