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
Condition: Chronic Kidney Disease; Type 2 Diabetes Mellitus
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2
Intervention: Finerenone (Kerendia, BAY94-8862); Placebo
Intervention description: Oral tablet; starting at 10 mg or 20 mg; once daily; received in previous interventional Phase 3 trial FIGARO-DKD; no new intervention was administered in this biomarker study.; Oral tablet; starting at 10 mg or 20 mg; once daily; received in previous interventional Phase 3 trial FIGARO-DKD; no new intervention was administered in this biomarker study.
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 951.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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 eGFR≥60 mL/min/1.73m^2).

          -  Sponsor request (after discussion with the investigator), for reasons such as a
             significant protocol deviation.