check_circleStudy Completed
Chronic kidney disease, Hypertension
Bayer Identifier:infoA unique number for a trial given by Bayer.
21592
ClinicalTrials.gov Identifier:infoA unique number for a trial given by United States government.
EudraCT Number:infoA unique reference for a trial given by European medical agency.
EU CT Number:infoA unique reference for a trial given by European medical agency under EU Clinical Trial Regulation
Not Available
A study in male and female participants (after menopause) with mild to moderate high blood pressure to learn how safe the study treatment BAY3283142 is, how it affects the body and how it moves into, through and out of the body after taking single and multiple doses
Trial purpose
Researchers are looking for a better way to treat people who have chronic kidney disease (CKD), a progressive decrease in the kidneys’ ability to work properly.
In people with CKD, the kidneys do not remove wastes and extra fluid from the blood as well as they should. 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. As many people with CKD do also suffer from high blood pressure, this study is done in people with mild to moderate high blood pressure to safeguard the use of BAY3283142 in people with CKD in later studies.
The main purpose of this study is to learn how safe different single and multiple doses of the study treatment BAY3283142 are compared to placebo in male and female participants (after menopause) with mild to moderate high blood pressure. A placebo is a treatment that looks like a medicine but does not have any medicine in it.
To answer this, the researchers will compare the number of participants who have medical problems after taking BAY3283142 to those treated with placebo. Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments.
Dependent on the treatment group, the participants will either take BAY3283142 or placebo as tablet once or twice a day. Patients will take one dose for 6 days and will then be switched to a higher dose for additional 6 days. In summary, three different dose combinations consisting of two different doses each will be tested.
Participants will be in the study for up to 7 weeks, including 12 treatment days (6 per dose step). They will stay in-house for 17 days starting two days before intake of the study treatment. In addition, one visit before and one visit after the in-house phase to the study site is planned.
During the study, the study team will:
• Check vital signs
• Take blood and urine samples
• Examine the participants’ heart health using electrocardiogram (ECG)
In people with CKD, the kidneys do not remove wastes and extra fluid from the blood as well as they should. 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. As many people with CKD do also suffer from high blood pressure, this study is done in people with mild to moderate high blood pressure to safeguard the use of BAY3283142 in people with CKD in later studies.
The main purpose of this study is to learn how safe different single and multiple doses of the study treatment BAY3283142 are compared to placebo in male and female participants (after menopause) with mild to moderate high blood pressure. A placebo is a treatment that looks like a medicine but does not have any medicine in it.
To answer this, the researchers will compare the number of participants who have medical problems after taking BAY3283142 to those treated with placebo. Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments.
Dependent on the treatment group, the participants will either take BAY3283142 or placebo as tablet once or twice a day. Patients will take one dose for 6 days and will then be switched to a higher dose for additional 6 days. In summary, three different dose combinations consisting of two different doses each will be tested.
Participants will be in the study for up to 7 weeks, including 12 treatment days (6 per dose step). They will stay in-house for 17 days starting two days before intake of the study treatment. In addition, one visit before and one visit after the in-house phase to the study site is planned.
During the study, the study team will:
• Check vital signs
• Take blood and urine samples
• Examine the participants’ heart health using electrocardiogram (ECG)
Key Participants Requirements
Sex
AllAge
30 - 78 YearsTrial summary
Enrollment Goal info
56The overall number of participants needed for a trial.
Trial Dates info
September 2022 - April 2023Trial dates are when the trial starts and ends. If they are in the future, then they are estimates and can change before or during a trial.
Phase info
Phase 1A phase is a step in the research of a new treatment.
Could I Receive a placebo info
YesA “placebo” looks like a treatment but usually does not have any real treatment. A placebo is used to make sure the effects of a treatment that are seen in a trial are actually caused by that treatment.
Products info
BAY3283142 A “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
NoA healthy volunteer is a person who takes part in a trial but does not have a disease or condition. Usually, healthy volunteers are in Phase 1 trials.
Where to participate
| Status | Institution | Location |
|---|---|---|
Completed | CRS Clinical-Research-Services Mannheim GmbH | Mannheim, 68167, Germany |
Completed | Charité Research Organisation GmbH | Berlin, 10117, Germany |
Completed | CTC North GmbH & Co. KG | Hamburg, 20251, Germany |
Completed | Medical Center Comac Medical EOOD | Sofia, 1612, Bulgaria |
Primary OutcomeinfoA primary outcome is the most important effect of a treatment that is measured in a trial. Most trials have one primary outcome measure, but some have more than one.
- Number of participants with treatment-emergent adverse events per treatment armdate_rangeTime Frame:Up to 7 days after end of treatment with study intervention
Secondary OutcomeinfoA secondary outcome is an effect of a treatment that is measured in a trial. A secondary outcome is less important than a primary outcome. But secondary outcomes are still important since they help researchers learn more about the effects of a treatment. Most clinical trials have more than one secondary outcome measure.
- Area under the concentration versus time curve in a dosing interval (AUCτ) after single dose of BAY3283142 on Day 1date_rangeTime Frame:Up to 24 hours post-dose
- AUCτ after single dose of BAY3283142 on Day 1 divided by dose (AUCτ/D)date_rangeTime Frame:Up to 24 hours post-dose
- Maximum observed drug concentration in measured matrix (Cmax) after single dose of BAY3283142 on Day 1date_rangeTime Frame:Up to 24 hours post-dose
- Cmax after single dose of BAY3283142 on Day 1 divided by dose (Cmax/D)date_rangeTime Frame:Up to 24 hours post-dose
- AUC in a dosing interval after multiple doses of BAY3283142 on Day 12 (AUCτ,md)date_rangeTime Frame:Up to 24 hours post-dose
- AUCτ,md after multiple doses of BAY3283142 on Day 12 divided by dose (AUCτ,md/D)date_rangeTime Frame:Up to 24 hours post-dose
- Maximum observed drug concentration in measured matrix after multiple doses of BAY3283142 on Day 12 (Cmax,md)date_rangeTime Frame:Up to 24 hours post-dose
- Cmax,md after multiple doses of BAY3283142 on Day 12 divided by dose (Cmax,md/D)date_rangeTime Frame:Up to 24 hours post-dose
Trial design
Trial Type info
InterventionalDescribes the nature of the clinical study.
Intervention Type info
DrugAn intervention is a drug, medical device, vaccine, or other treatment that is being studied in a trial or is already approved for all patients to use. An intervention can also include treatments like changing diet and exercise, or educating people about a health topic.
Trial Purpose info
TreatmentThe main reason the clinical trial is being done.
Allocation info
RandomizedAllocation is the way treatments are assigned to the people in the trial.
Blinding info
N/A“Blinding” means a person in a trial does not know what treatment they are using. Everyone in the trial knows which treatments they might get if they join the trial, but they do not always know which treatment they use during the trial.
Assignment info
Parallel AssignmentAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
3A “trial arm” is a group of people in a trial. Each trial arm is assigned to use a specific treatment. Types of trial arms are: Experimental arm is a group assigned to use the treatment being studied in the trial Active comparator arm is a group assigned to use a treatment considered to be effective. The results of this group are compared to the results of the experimental arm. Placebo arm is a group assigned to use a placebo. A “placebo” looks like a treatment but usually does not have any real treatment. The results of this group are compared to the experimental arm. This helps make sure any effects that are seen in the experimental arm are actually caused by the main treatment being studied. No intervention arm is a group that is not assigned to use a treatment. The people in this group do not use any treatment during the trial.