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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT05013008

Public ClinicalTrials.gov record NCT05013008. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 6:21 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05013008
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Bayer
Industry
Enrollment
951 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 17, 2021
Primary completion
Dec 30, 2021
Completion
Dec 30, 2021
Last update posted
Sep 14, 2023

2021

United States locations

U.S. sites
13
U.S. states
9
U.S. cities
12
Facility City State ZIP Site status
Valley Clinical Trials, Inc. - Northridge Northridge California 91325
Saviers Medical Group Port Hueneme California 93041
Chase Medical Research, LLC Waterbury Connecticut 06708
Florida Kidney Physicians - Fort Lauderdale Fort Lauderdale Florida 33308
Indago Research & Health Center, Inc. Hialeah Florida 33012
San Marcus Research Clinic, Inc. Miami Lakes Florida 33014
Floridian Clinical Research, LLC Miami Lakes Florida 33016
East-West Medical Research Institute Honolulu Hawaii 96814
Crescent City Clinical Research Center, LLC Metairie Louisiana 70006
Joslin Diabetes Center Boston Massachusetts 02215
Kansas City VA Medical Center Kansas City Missouri 64128
Randolph Medical Associates Asheboro North Carolina 27203
Clinical Advancement Center, PLLC San Antonio Texas 78212-4740

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 102 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05013008, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 14, 2023 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05013008 live on ClinicalTrials.gov.

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