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NCT05013008 · ClinicalTrials.gov registry record · Phase 2
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 Phase 2 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 951
- Enrollment target
NCT05013008 is a Phase 2 study that has completed, run by Bayer. The registered enrollment target is 951 participants.
The verdict
NCT05013008, a Phase 2 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 951 participants
- Enrollment target
Study 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 trea
Interventions
- DRUG Placebo
- DRUG Finerenone (Kerendia, BAY94-8862)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 951 participants |
| Start Date | 2021-08-18 |
| Est. Completion | 2021-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05013008
The ClinicalTrials.gov registry entry for NCT05013008 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 951 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05013008 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05013008 about?
NCT05013008 is a clinical study titled "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". 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 refe...
What is the current status of trial NCT05013008?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 951 participants. The study started on 2021-08-18. Estimated completion is 2021-12-31.
What interventions are being tested in trial NCT05013008?
The interventions under investigation include: Placebo (DRUG), Finerenone (Kerendia, BAY94-8862) (DRUG).
Who is sponsoring clinical trial NCT05013008?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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