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NCT05526157 · ClinicalTrials.gov registry record
An Observational Study, Called FINEGUST, to Learn More About How People With Chronic Kidney Disease and Type 2 Diabetes Are Treated and How the Introduction of New Treatment Options, Like Finerenone, Impacts Clinical Practice
A clinical trial, sponsored by Bayer.
- Completed
- Registry status
- 50,000
- Enrollment target
NCT05526157 is a clinical trial that has completed, run by Bayer. The registered enrollment target is 50,000 participants.
The verdict
NCT05526157 has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- 50,000 participants
- Enrollment target
Study Summary
This is an observational study in which data from people with chronic kidney disease (CKD) and type 2 diabetes (T2D) who have already started or will start CKD or T2D treatment are collected and studied. In observational studies, only observations are made without specified advice or interventions. People receiving the following CKD or T2D treatments as recommended by their doctors will be included: * Sodium-glucose cotransporter 2 inhibitors (SGLT2i), * Glucagon-like peptide-1 receptor agonists (GLP-1 RA), * Steroidal mineralocorticoid receptor antagonists (sMRA), * Finerenone, a non-steroidal mineralocorticoid receptor antagonist (nsMRA) * Other nsMRA (only in Japan) Kidneys filter extra water and waste from the blood and make urine. CKD is a long-term, progressive decrease in the kidneys' ability to properly filter blood. 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. The new drug, finerenone, works by blocking certain proteins, called mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys. By lowering their stimulation, finerenone reduces the risk of progressive worsening of the kidney disease. Finerenone is available and approved in several countries for doctors to prescribe to people with CKD and T2D. The main purpose of the study is to collect and describe characteristics of participants in each treatment group who have started or will start treatment before and after finerenone became available. To do this, the researchers will collect data on: * Patient characteristics (e.g., age sex) of the participants * Clinical characteristics (e.g., history of CKD and T2D, heart and liver health, other health problems) of the participants * Treatments for T2D and CKD * Other medications used Data will be grouped by typ
Interventions
- DRUG Sodium-glucose cotransporter 2 inhibitors (SGLT2i)
- DRUG Glucagon-like peptide-1 receptor agonists (GLP 1 RA)
- DRUG Finerenone (Kerendia, BAY 948862)
- DRUG Steroidal mineral corticoid receptor antagonists (sMRA)
- DRUG Non-steroidal mineral corticoid receptor antagonists (nsMRA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50,000 participants |
| Start Date | 2022-10-01 |
| Est. Completion | 2024-09-05 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05526157
The ClinicalTrials.gov registry entry for NCT05526157 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 50,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Sodium-glucose cotransporter 2 inhibitors (SGLT2i) is the first listed.
NCT05526157 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05526157 about?
NCT05526157 is a clinical study titled "An Observational Study, Called FINEGUST, to Learn More About How People With Chronic Kidney Disease and Type 2 Diabetes Are Treated and How the Introduction of New Treatment Options, Like Finerenone, Impacts Clinical Practice". This is an observational study in which data from people with chronic kidney disease (CKD) and type 2 diabetes (T2D) who have already started or will start CKD or T2D treatment are collected and studied. In observational studies, only observations are made without specified advice or interventions. ...
What is the current status of trial NCT05526157?
This trial is currently completed. The enrollment target is 50,000 participants. The study started on 2022-10-01. Estimated completion is 2024-09-05.
What interventions are being tested in trial NCT05526157?
The interventions under investigation include: Sodium-glucose cotransporter 2 inhibitors (SGLT2i) (DRUG), Glucagon-like peptide-1 receptor agonists (GLP 1 RA) (DRUG), Finerenone (Kerendia, BAY 948862) (DRUG), Steroidal mineral corticoid receptor antagonists (sMRA) (DRUG), Non-steroidal mineral corticoid receptor antagonists (nsMRA) (DRUG).
Who is sponsoring clinical trial NCT05526157?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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