Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-01-02 @ 4:31 AM
Study NCT ID:
NCT05515432
Status:
COMPLETED
Last Update Posted:
2023-08-21
First Post:
2022-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Learn How the Study Treatment BAY3283142 Taken as Single Dose by Mouth Moves Into, Through, and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Reduced Kidney Function Compared to Participants With Normal Kidney Function of Similar Age, Gender, and Weight
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
Investigation of Pharmacokinetics, Safety and Tolerability of a Single Oral Dose of BAY 3283142 in Participants With Renal Impairment Compared to an Age, Gender and Weight Matched Control Group in an Open-label Study Design
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Researchers are looking for a better way to treat people who have chronic kidney disease (CKD).
The kidneys filter extra water and waste out of the blood and make urine. CKD is a long-term, progressive, decrease in the kidneys' ability to filter the blood properly. High blood pressure makes it more likely that the CKD gets worse.
The study treatment BAY3283142 is under development for treating CKD. It activates a protein called soluble guanylate cyclase (sGC) that generates cGMP - a molecule that relaxes blood vessels and is thought to have beneficial effects in CKD.
The participants do not benefit from this study. However, the study will provide information on how to use BAY3283142 in subsequent studies in people with CKD.
In previous studies, BAY3283142 was studied in participants with normal kidney function. As kidneys play a role in removal of drugs from the body, the degree of kidney function could influence the amount of BAY3283142 in the blood. Higher amounts may occur in people with reduced kidney function.
Therefore, the main purpose of this study is to learn how the study treatment BAY3283142 moves into, through, and out of the body in participants with mild to severe reduction of kidney function compared to matched participants with normal kidney function.
To answer this, the researchers will compare:
* the (average) total level of BAY3283142 in the blood (also called AUC).
* the (average) highest level of BAY3283142 in the blood (also called cmax) between the different groups. Participants will be in one of four groups based on how much their kidney function is reduced (mild, moderate, severe, end stage kidney disease) or in the control group.
All participants will take a single dose of BAY3283142 as tablet by mouth. Each participant will be in the study for approximately 4 weeks including an in-house stay of 6 days (with 5 overnight stays). In addition, a screening visit to the study site before the in-house stay is planned.
During the study, the study team will:
* check vital signs
* do physical examinations
* take blood and urine samples
* examine heart health using an electrocardiogram (ECG)
* ask the participants questions about how they are feeling and what adverse events they are having
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
The kidneys filter extra water and waste out of the blood and make urine. CKD is a long-term, progressive, decrease in the kidneys' ability to filter the blood properly. High blood pressure makes it more likely that the CKD gets worse.
The study treatment BAY3283142 is under development for treating CKD. It activates a protein called soluble guanylate cyclase (sGC) that generates cGMP - a molecule that relaxes blood vessels and is thought to have beneficial effects in CKD.
The participants do not benefit from this study. However, the study will provide information on how to use BAY3283142 in subsequent studies in people with CKD.
In previous studies, BAY3283142 was studied in participants with normal kidney function. As kidneys play a role in removal of drugs from the body, the degree of kidney function could influence the amount of BAY3283142 in the blood. Higher amounts may occur in people with reduced kidney function.
Therefore, the main purpose of this study is to learn how the study treatment BAY3283142 moves into, through, and out of the body in participants with mild to severe reduction of kidney function compared to matched participants with normal kidney function.
To answer this, the researchers will compare:
* the (average) total level of BAY3283142 in the blood (also called AUC).
* the (average) highest level of BAY3283142 in the blood (also called cmax) between the different groups. Participants will be in one of four groups based on how much their kidney function is reduced (mild, moderate, severe, end stage kidney disease) or in the control group.
All participants will take a single dose of BAY3283142 as tablet by mouth. Each participant will be in the study for approximately 4 weeks including an in-house stay of 6 days (with 5 overnight stays). In addition, a screening visit to the study site before the in-house stay is planned.
During the study, the study team will:
* check vital signs
* do physical examinations
* take blood and urine samples
* examine heart health using an electrocardiogram (ECG)
* ask the participants questions about how they are feeling and what adverse events they are having
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2022-000858-28 | EUDRACT_NUMBER | None | View |