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Mineralocorticoid Receptor Antagonist

Participants diagnosed with CKD and T2D for Chronic Kidney Disease

N/A
Recruiting
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 62 months
Awards & highlights

Study Summary

This is an observational study in people with chronic kidney disease (CKD) and type 2 diabetes (T2D) who will be receiving finerenone. Kidneys filter extra water and waste out of the blood and make urine. CKD is a long-term, progressive, decrease in the kidneys' ability to filter the blood properly. In people with T2D, the body does not make enough of a hormone called insulin, or does not use insulin well enough, resulting in high blood sugar levels that can cause damage to the kidneys. As a result, CKD can occur as a complication of T2D. Finerenone works by blocking certain proteins, called mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys and the heart. By lowering their stimulation, finerenone reduces the risk of kidney disease progressively getting worse. Finerenone is available and approved for doctors to prescribe to people with CKD and T2D. Since it has only recently become available for these patients, there is a need for more information about the use of finerenone in the real-world setting. The main purpose of the study is to learn more about treatment patterns in people with CKD and T2D who just started or will start finerenone treatment as decided and prescribed by their doctor as part of their routine medical care. To answer this question, the researchers will collect data on: Clinical characteristics (e.g., history of CKD and T2D, blood pressure, heart health) of the participants Reasons for starting finerenone Reasons for stopping finerenone early How long participants have been taking finerenone (planned by their doctor compared to actual time it was taken) Dosing of finerenone Other medications used while taking finerenone The researchers will also collect data on medical problems (called adverse events) that the participants may have during the study. All adverse events are collected, even if they might not be related to the study treatment. Hyperkalemia, a medical term used to describe a potassium level in the blood that is higher than normal, is of special interest when finerenone is combined with some medications commonly taken to control blood pressure. Researchers want to know how often higher potassium levels occur, and when it leads to: Stopping finerenone treatment too early Dialysis (a medical procedure to filter the blood of extra water and waste) Care in a hospital All data will come from medical records or from interviews study doctors will have with the participants during visits that take place during routine medical care. Participants in the US will be invited to provide voluntary blood and urine samples that could be analyzed later to better understand possible changes in protein or nucleic acid levels over time. Each participant will be in the study for 12 months. This time participating in the study may be shorter if their finerenone treatment is stopped early or the study comes to an end as planned in September 2027.

Eligible Conditions
  • Chronic Kidney Disease
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 62 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 62 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Descriptive analysis of clinical characteristics of participants with chronic kidney disease (CKD) and with type 2 diabetes(T2D).
Descriptive summary of reasons for discontinuation of finerenone.
Descriptive summary of reasons for introducing finerenone.
+4 more
Secondary outcome measures
Occurrence of adverse events (AEs) and serious adverse events (SAEs)
Occurrence of hyperkalemia
Other outcome measures
Descriptive summary for healthcare resource utilization.
Occurrence of newly diagnosed diabetic retinopathy or progression of existing disease at treatment initiation

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants diagnosed with CKD and T2DExperimental Treatment1 Intervention
Participants who are newly prescribed finerenone under routine treatment conditions.

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,239 Previous Clinical Trials
25,327,228 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3579 spots leftby Sep 2027