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NCT05640180 · ClinicalTrials.gov registry record

An Observational Study Called FLAMINgO to Learn More About the Treatment Combination of Finerenone and SGLT2 Inhibitors in People With Long-term Kidney Disease (Chronic Kidney Disease) Together With Type 2 Diabetes by Using Routine Medical Care Data and Past Clinical Study Results

A clinical trial, sponsored by Bayer.

Completed
Registry status
17,847
Enrollment target

NCT05640180: Completed study, sponsored by Bayer.

NCT05640180 is a clinical trial that has completed, run by Bayer. The registered enrollment target is 17,847 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05640180 has completed, sponsored by Bayer.

COMPLETED
Registry status
17,847 participants
Enrollment target

Study Summary

This is an observational study, in which data from the past of people with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied. The participants in this study were treated in the past with a type of drug called SGLT2 inhibitor alone or with SGLT2 inhibitors in combination with finerenone. In observational studies, only observations are made without specified advice or interventions. CKD is a long-term progressive decrease in the kidneys' ability to work 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. Chronic kidney disease often occurs together with / as a consequence of type 2 diabetes. SGLT2 inhibitors lower blood sugar levels by increasing sugar removal from the blood into the urine. SGLT2 inhibitors are the standard of care (SOC) treatment for CKD and T2D. SOC is the treatment that medical experts consider most appropriate for a disease. The drug finerenone works by blocking certain proteins, called mineralocorticoid receptors. By doing this, finerenone reduces damage to kidneys, heart and blood vessels. It is available and approved for doctors to prescribe to people with CKD together with T2D. Results from two earlier clinical studies called FIDELIO-DKD and FIGARO-DKD in participants with CKD together with T2D are available. These results suggest that the treatment combination of finerenone and SGLT2 inhibitors may work better than taking SGLT2 inhibitors alone. The treatment combination may further slow down a worsening of the participants' * kidney disease * heart and blood circulation health. Due to a limited number of participants treated with SGLT2 inhibitors alone however, the data from the two earlier studies does not allow to draw conclusions. The main objective of this study is to combine additional real world data from SGLT2 inhibitor users with the study data from the

Interventions

  • DRUG Finerenone (Kerendia, BAY94-8862)
  • DRUG Sodium-glucose cotransporter-2 inhibitors (SGLT2i)

Trial Details

FieldValue
Enrollment Target 17,847 participants
Start Date 2022-11-23
Est. Completion 2023-12-20
Bayer

591 total trials

What the finished NCT05640180 record still lists

NCT05640180 is an observational study that tracks outcomes without assigning an intervention. Its 17,847 participants enrollment target places it among the larger protocols in the corpus.

The record links to 0 conditions, and to 2 interventions - of which Finerenone (Kerendia, BAY94-8862) is the first listed.

NCT05640180 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05640180 about?

NCT05640180 is a clinical study titled "An Observational Study Called FLAMINgO to Learn More About the Treatment Combination of Finerenone and SGLT2 Inhibitors in People With Long-term Kidney Disease (Chronic Kidney Disease) Together With Type 2 Diabetes by Using Routine Medical Care Data and Past Clinical Study Results". This is an observational study, in which data from the past of people with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied. The participants in this study were treated in the past with a type of drug called SGLT2 inhibitor alone or with SGLT2 inhibitors in combination wi...

What is the current status of trial NCT05640180?

This trial is currently completed. The enrollment target is 17,847 participants. The study started on 2022-11-23. Estimated completion is 2023-12-20.

What interventions are being tested in trial NCT05640180?

The interventions under investigation include: Finerenone (Kerendia, BAY94-8862) (DRUG), Sodium-glucose cotransporter-2 inhibitors (SGLT2i) (DRUG).

Who is sponsoring clinical trial NCT05640180?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT05640180, the US trial registry maintained by the National Library of Medicine. NCT05640180 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.