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NCT06608212 · ClinicalTrials.gov registry record
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Care in the United States
A clinical trial of Type 2 Diabetes Mellitus and Chronic Kidney Disease, sponsored by Bayer.
- Active
- Registry status
- 150,000
- Enrollment target
- 1
- Study location
NCT06608212: Active study of Type 2 Diabetes Mellitus and Chronic Kidney Disease, sponsored by Bayer.
NCT06608212 is a study of Type 2 Diabetes Mellitus and Chronic Kidney Disease that is active but no longer recruiting, run by Bayer. The registered enrollment target is 150,000 participants, above the 1,806-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (8206% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06608212, a study of Type 2 Diabetes Mellitus and Chronic Kidney Disease, is active but no longer recruiting, sponsored by Bayer.
- ACTIVE NOT RECRUITING
- Registry status
- 150,000 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an observational study in which data from people with chronic kidney disease (CKD) and Type 2 diabetes mellitus (T2D) are collected and studied. In observational studies, only observations are made without participants receiving any advice or any changes to healthcare. CKD is a long-term condition in which the kidneys' ability to work properly gradually decreases over time. It is common in people with Type 2 diabetes mellitus (T2D), a condition in which glucose levels rise in the blood. People who have T2D and CKD may also develop heart disease over time. The study drug, finerenone, is already approved for doctors to prescribe to people with CKD and T2D in the US. It blocks the activity of a protein involved in worsening kidney function. The participants in this study are allowed to take finerenone as part of their regular care from their doctors. The main purpose of the study is to learn about how safe finerenone is and how well it works in people with CKD and T2D in routine medical care. To do this, researchers will collect information about the time to first occurrence of any of the following heart-related problems for participants in the US who are taking finerenone and those who are not taking it: * Heart attacks * Hospitalization due to heart failure The data will come from the electronic healthcare records of people with CKD and T2D in the US who are allowed to take finerenone after July 2021. Researchers will track participants' data and will follow them until the occurrence of heart-related problems, the participant's data is no longer available, there is a change in the participant's treatment strategy, or the end of the study. In this study, only available data from routine care are collected. No visits or tests are required as part of this study.
Primary Outcome
The composite cardiovascular outcome includes an inpatient hospital diagnosis of fatal or nonfatal acute myocardial infarction or an inpatient hospitalisation with a primary diagnosis of heart failure.
Conditions Studied
Interventions
- DRUG Finerenone (Kerendia, BAY948862)
- DRUG Others except finerenone
Study Locations (1)
New Jersey
- Bayer - Whippany
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150,000 participants |
| Start Date | 2024-10-09 |
| Est. Completion | 2025-12-31 |
What the registry record for NCT06608212 still lists
NCT06608212 is an observational study that tracks outcomes without assigning an intervention. Its 150,000 participants enrollment target places it among the larger protocols in the corpus, above the 1,806-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (8206% higher).
The record links to 2 conditions, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Finerenone (Kerendia, BAY948862) is the first listed.
NCT06608212 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT06608212 about?
NCT06608212 is a clinical study titled "An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Care in the United States". This is an observational study in which data from people with chronic kidney disease (CKD) and Type 2 diabetes mellitus (T2D) are collected and studied. In observational studies, only observations are made without participants receiving any advice or any changes to healthcare. CKD is a long-term c...
What is the current status of trial NCT06608212?
This trial is currently active not recruiting. The enrollment target is 150,000 participants. The study started on 2024-10-09. Estimated completion is 2025-12-31.
What conditions does trial NCT06608212 study?
This clinical trial studies the following conditions: Type 2 Diabetes Mellitus, Chronic Kidney Disease.
What interventions are being tested in trial NCT06608212?
The interventions under investigation include: Finerenone (Kerendia, BAY948862) (DRUG), Others except finerenone (DRUG).
Who is sponsoring clinical trial NCT06608212?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06608212 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06608212's enrollment target sits among peer trials
150,000 1st of 130 higher than 130 of 130 other Type 2 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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