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

  • STATUS
    Recruiting
  • days left to enroll
    35
  • participants needed
    600
  • sponsor
    Bayer
Updated on 17 November 2021
type 2 diabetes mellitus
sugars

Summary

Researchers are looking for a better way to treat people who have chronic kidney disease (CKD), a long-term, progressive decrease in the kidneys' ability to work properly. When CKD happens in people with type 2 diabetes mellitus, a condition characterized by high blood sugar levels, CKD is also referred to as diabetic kidney disease (DKD).

FIGARO-BM is an add-on study in which blood draws that were collected in the FIGARO-DKD study are further analyzed. No additional blood draws (also referred to as biological samples) or data will be obtained from the participants, nor will any additional or new study intervention be introduced. No visit or patient contact other than for obtaining the agreement by the patients (also called informed consent) will be required.

Inflammation and scarring are both seen as responsible for worsening of chronic kidney disease. There is much information from animal studies that the study treatment finerenone (BAY94-8862) works against inflammation and against scarring (also called fibrosis) in organs such as the kidney.

In this exploratory study researchers want to learn more about the study treatment finerenone (BAY94-8862). To find this out, this study will examine substances called biomarkers in blood draws from participants in the FIGARO-DKD study. Biomarkers are used as indicators of biological processes, disease processes or responses to medication. The biomarkers that will be examined stand for inflammation, organ scarring (also called fibrosis), blood vessel function and congestion.

The main question of this study is whether there are differences between these biomarkers in the group of participants who received finerenone and the group of participants who received a placebo in the FIGARO-DKD study. A placebo looks like a treatment but does not have any medicine in it. To answer this question, the researchers will compare the levels of these biomarkers between the two groups at different time points after starting the study treatment. Blood samples for this study will be obtained from FIGARO-DKD study sites with a high number of participants who had been treated with finerenone or placebo for at least 24 months. This information will be combined with other information from biomarker examinations already available in the FIGARO-DKD study.

Details
Condition chronic renal insufficiency, NIDDM, Diabetes Mellitus, Chronic renal failure, chronic kidney disease, type 2 diabetes mellitus, chronic kidney disease (ckd), type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment Placebo, Finerenone (BAY94-8862)
Clinical Study IdentifierNCT05013008
SponsorBayer
Last Modified on17 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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 eGFR60 mL/min/1.73m^2)
Sponsor request (after discussion with the investigator), for reasons such as a significant protocol deviation
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