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

Part of paid clinical trials in Whippany, New Jersey.

Sponsor
Bayer
Study ID
NCT05640180
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Finerenone (Kerendia, BAY94-8862) — DRUG
    Retrospective cohort analysis using randomized clinical trials data.
  • Sodium-glucose cotransporter-2 inhibitors (SGLT2i) — DRUG
    Retrospective cohort analysis using United States Optum Electronic Health Records data.

Study Details

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 earlier studies to get clearer results. Before combining the data however, statistical tests need to prove that this is allowed. If this is the case, the new combined "control" data can be compared with the data from the combination treatment group from the earlier studies. This will allow the researchers to get more proof and draw conclusions of how well the treatment combination works compared to SGLT2 inhibitors alone. The real world data will come from a database called Optum. It will cover the period from January 2013 to September 2021. Only data from people who are similar to the participants of the control group of the earlier studies and meet certain criteria will be selected. Only data from the past is collected and studied. There are no required visits or tests in this study.

Key Dates

Start date
Nov 23, 2022
Status verified
Jan 2024
Primary completion
Dec 20, 2023
Completion
Dec 20, 2023

Study Design

Enrollment
17,847 participants (actual)

Arms

  • Arm: External control arm (ECA)
    ECA built from patients from Optum® Electronic Health Records (EHR) real world data (RWD) that closely match Sodium/glucose cotransporter-2 inhibitors (SGLT2i) subgroups from the randomized clinical trials (RCTs).
  • Arm: Internal control arm (ICA)
    ICA built from participants from two RCTs called FIDELIO-DKD and FIGARO-DKD pooled for the FIDELITY analyses. FIDELIO-DKD/FIGARO-DKD placebo controls treated with SGLT2is at baseline.

Primary Outcome Measure

Time to the first occurrence of the composite endpoint of onset of kidney failure, a sustained decrease of eGFR ≥ 40% from baseline over at least 4 weeks, or renal death [ Time Frame: From randomization up until the first occurrence of the primary renal composite endpoint, or censoring at the end of the study, with a maximum follow-up time of 48 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
BayerWhippanyNew Jersey07981-

Find similar trials in Whippany, NJ

By condition
Chronic kidney diseaseType 2 diabetes
By specialty
NephrologyKidney diseaseEndocrinologyMetabolic healthWeight loss
By research site
Bayer· Whippany, NJ

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