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

Phase 2

Completed

Conditions: Chronic Kidney Disease
Type 2 Diabetes Mellitus

Interventions: Drug: Placebo
Drug: Finerenone (Kerendia, BAY94-8862)

Registration Number: NCT05013008

Lead Sponsor: Bayer

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 951

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants received matching placebo once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study.
Finerenone	Finerenone (Kerendia, BAY94-8862)	Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study.

Primary Outcome Measures

Name	Time	Method
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers	At 4 months (Visit 3) of treatment and 36 months (Visit 11) of treatment	The normalized protein expression (NPX) of biomarker levels were analyzed for the set of 27 pre-defined plasma biomarkers. NPX is a unit on log2-scale that is logarithmically related to protein concentration. Linear NPX (2\^NPX) was calcuated for descriptive analyses of the biomarker levels at each visit. Ratios of Visit 11 (36 months of treatment) to Visit 3 (4 months of treatment) were calculated to show the change in the plasma biomarker levels. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. Note, NPX units (Olink concentration units) are always relative units and can only be interpreted in the context of an individual study, i.e. to compare two conditions or timepoints ("change in NPX"). Equal nominal concentration values (same NPX units) for two different biomarkers measured by Olink Explore does not mean that both markers have the same absolute concentration.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (115): Valley Clinical Trials, Inc. - Northridge
🇺🇸
Northridge, California, United States
Saviers Medical Group
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Port Hueneme, California, United States
Chase Medical Research, LLC
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Waterbury, Connecticut, United States
Florida Kidney Physicians - Fort Lauderdale
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Fort Lauderdale, Florida, United States
Indago Research & Health Center, Inc.
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Hialeah, Florida, United States
San Marcus Research Clinic, Inc.
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Miami Lakes, Florida, United States
Floridian Clinical Research, LLC
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Miami Lakes, Florida, United States
East-West Medical Research Institute
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Honolulu, Hawaii, United States
Crescent City Clinical Research Center, LLC
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Metairie, Louisiana, United States
Joslin Diabetes Center
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Boston, Massachusetts, United States
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Valley Clinical Trials, Inc. - Northridge
🇺🇸Northridge, California, United States