An add-on Study to the FIGARO-DKD Study Called FIGARO-BM to Learn About the Link Between Biomarkers (Substances in the Blood Used as Indicators of Biological Processes, Disease Processes or Responses to Medication) and Finerenone in FIGARO-DKD Participants
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
This study will only include participants who were enrolled in the FIGARO-DKD study (NCT02545049) and had received up to 20 mg finerenone or placebo for ≥24 months.
For each participant, pharmacokinetic (PK) plasma samples from Visit 3 and at least 2 other Visits (Visit 5, Visit 8, Visit 11) must be available on storage from the main study FIGARO-DKD.
You may not be if
Participants which did not show overall compliance of 80 to 120% with study intervention in FIGARO-DKD.
Participants which were not part of the full analysis set (FAS) of FIGARO-DKD.
Participants with known fatal outcome.
Participants with baseline estimated glomerular filtration rate (eGFR) ≤25 mL/min/1.73m\^2.
Participants with low baseline risk (normal albuminuria and eGFR≥60 mL/min/1.73m\^2).
Sponsor request (after discussion with the investigator), for reasons such as a significant protocol deviation.
Clareo Health | An add-on Study to the FIGARO-DKD Study Called FIGARO-BM to Learn About the Link Between Biomarkers (Substances in the Blood Used as Indicators of Biological Processes, Disease Processes or Responses to Medication) and Finerenone in FIGARO-DKD Participants
