NCT05013008

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

A Non-blinded Retrospective Biomarker add-on Study to FIGARO-DKD for Bioprofiling the Pharmacodynamic Response to Finerenone in FIGARO-DKD Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 951 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Disease
• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Finerenone (Kerendia, BAY94-8862)	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.
DRUG	Placebo	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.

Timeline

• Start date: 2021-08-18
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2021-08-19
• Last updated: 2023-09-15
• Results posted: 2023-03-31

Locations

115 sites across 21 countries: United States, Australia, Austria, Belgium, Bulgaria, Canada, Czechia, Denmark, Finland, Hong Kong, Israel, Italy, Japan, Netherlands, Portugal, Russia, Singapore, South Korea, Spain, Sweden, Taiwan

Regulatory

• FDA-regulated drug study