Chronic Kidney DiseasePhase 1NCT05491642
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
A Phase 1 study testing BAY3283142 in people with Chronic Kidney Disease and Hypertension, run by Bayer at 4 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 78 years
- Conditions the study is for
- Chronic Kidney Disease, Hypertension
- What is being tested?
- BAY3283142
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 8 Sep 2022to 28 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be 30 to 78 years of age inclusive, at the time of signing the informed consent.
- Participants with diagnosis of mild to moderate systemic arterial hypertension receiving stable treatment for ≥8 weeks before the screening visit with not more than 2 antihypertensive drugs (note: 2 antihypertensive drugs combined within one pill count as 2 antihypertensive drugs).
- Mean systolic blood pressure (SBP) 120 - 160 mm Hg and mean diastolic blood pressure (DBP) 70-95 mm Hg at screening (mean out of triplicate measurements after supine rest for 15 min at screening).
- Estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73 m^2 (Chronic Kidney Disease Epidemiology Collaboration [CKD-Epi] formula) at screening and Study Day -2.
- Men and confirmed postmenopausal women.
Who cannot join
- Acute coronary syndrome (STEMI, NSTEMI, unstable angina, CABG, PCI, cardiac surgery).
- Ventricular tachycardia, atrial fibrillation, sick sinus syndrome, WPW syndrome.
- Thrombo-embolic events, e.g. stroke, TIA, deep vein thrombosis, pulmonary embolism.
- Systemic diseases: cancer (with the exception of appropriately treated basal cell carcinomas of the skin or uterine carcinoma in situ), autoimmune diseases (including also topically treated autoimmune diseases such as atopic dermatitis).
- Latent bleeding risk (diabetic retinopathy, history of gastrointestinal bleeding due to e.g. ulcers), inherited or acquired coagulopathies.
- Orthostatic intolerance in the modified standing blood pressure procedure at screening.
Show all 12Show fewer
- Long-acting or short-acting nitrates or NO donors for any route including isosorbide dinitrate, isosorbide-5-mononitrate, pentaerythritol tetranitrate, nicorandil, nitrotriglyceride, molsidomin.
- Phosphodiesterase-5 (PDE-5) inhibitors or other soluble guanylate cyclase (sGC) stimulators or activators.
- Inhibitors of Uridine-5'-diphospho glucuronosyltransferase (UGT) 1A1, 1A3, 1A8 (e.g., probenecid) from 7 days before first study intervention until follow-up.
- Signs of hepatic dysfunction at the screening visit or at randomization as indicated by at least one of the following:
- increases in isolated hepatic enzymes >1.3 fold ULN (alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [AP], γ-GT).
- Bilirubin > 1.3 fold ULN.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany3 sites
Charité Research Organisation GmbH
Berlin, 10117
CTC North GmbH & Co. KG
Hamburg, 20251
CRS Clinical-Research-Services Mannheim GmbH
Mannheim, Baden-Wurttemberg, 68167
About this study
Official title: Study in Male / Postmenopausal Female Participants With Mild to Moderate Arterial Hypertension to Investigate Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of BAY 3283142 in a Randomized, Multi-center, Placebo-controlled, Single-blind, Group Comparison Design
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.
Read more
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)
- Conditions
- Chronic Kidney Disease, Hypertension
- Being tested
- BAY3283142, Placebo to BAY3283142
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY3283142Drug
Oral administration
Placebo to BAY3283142Drug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Up-titration Scheme 1 | Experimental | Participants will receive 12 days treatment in total. Receives: Drug: BAY3283142; Drug: Placebo to BAY3283142 |
| Up-titration Scheme 2 | Experimental | Participants will receive 12 days treatment in total. Receives: Drug: BAY3283142; Drug: Placebo to BAY3283142 |
| Up-titration Scheme 3 | Experimental | Participants will receive 12 days treatment in total. Receives: Drug: BAY3283142; Drug: Placebo to BAY3283142 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events per treatment arm
Measured: Up to 7 days after end of treatment with study intervention
Secondary outcomes (8)
Area under the concentration versus time curve in a dosing interval (AUCτ) after single dose of BAY3283142 on Day 1
Measured: Up to 24 hours post-dose
AUCτ after single dose of BAY3283142 on Day 1 divided by dose (AUCτ/D)
Measured: Up to 24 hours post-dose
Maximum observed drug concentration in measured matrix (Cmax) after single dose of BAY3283142 on Day 1
Measured: Up to 24 hours post-dose
Cmax after single dose of BAY3283142 on Day 1 divided by dose (Cmax/D)
Measured: Up to 24 hours post-dose
AUC in a dosing interval after multiple doses of BAY3283142 on Day 12 (AUCτ,md)
Measured: Up to 24 hours post-dose
AUCτ,md after multiple doses of BAY3283142 on Day 12 divided by dose (AUCτ,md/D)
Measured: Up to 24 hours post-dose
Maximum observed drug concentration in measured matrix after multiple doses of BAY3283142 on Day 12 (Cmax,md)
Measured: Up to 24 hours post-dose
Cmax,md after multiple doses of BAY3283142 on Day 12 divided by dose (Cmax,md/D)
Measured: Up to 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start8 Sep 2022
- Primary completion3 Jan 2023
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491642
- Sponsor's protocol ID
- 21592
- Other IDs
- 2022-001268-84
- Status last verified
- May 2023
- First submitted
- 5 Aug 2022
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study in Male / Postmenopausal Female Participants With Mild to Moderate Arterial Hypertension to Investigate Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of BAY 3283142 in a Randomized, Multi-center, Placebo-controlled, Single-blind, Group Comparison Design
- ClinicalTrials.gov ID
- NCT05491642
- Acronym / sponsor ID
- 21592
- Conditions
- Chronic Kidney Disease, Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Up-titration Scheme 1 | Experimental | Drug: BAY3283142, Drug: Placebo to BAY3283142Participants will receive 12 days treatment in total. |
| Up-titration Scheme 2 | Experimental | Drug: BAY3283142, Drug: Placebo to BAY3283142Participants will receive 12 days treatment in total. |
| Up-titration Scheme 3 | Experimental | Drug: BAY3283142, Drug: Placebo to BAY3283142Participants will receive 12 days treatment in total. |
Who may qualify
- Ages
- 30 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant must be 30 to 78 years of age inclusive, at the time of signing the informed consent.
- Participants with diagnosis of mild to moderate systemic arterial hypertension receiving stable treatment for ≥8 weeks before the screening visit with not more than 2 antihypertensive drugs (note: 2 antihypertensive drugs combined within one pill count as 2 antihypertensive drugs).
- Mean systolic blood pressure (SBP) 120 - 160 mm Hg and mean diastolic blood pressure (DBP) 70-95 mm Hg at screening (mean out of triplicate measurements after supine rest for 15 min at screening).
- Estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73 m^2 (Chronic Kidney Disease Epidemiology Collaboration [CKD-Epi] formula) at screening and Study Day -2.
- Men and confirmed postmenopausal women.
Key exclusion criteria (12 listed)
- Acute coronary syndrome (STEMI, NSTEMI, unstable angina, CABG, PCI, cardiac surgery).
- Ventricular tachycardia, atrial fibrillation, sick sinus syndrome, WPW syndrome.
- Thrombo-embolic events, e.g. stroke, TIA, deep vein thrombosis, pulmonary embolism.
- Systemic diseases: cancer (with the exception of appropriately treated basal cell carcinomas of the skin or uterine carcinoma in situ), autoimmune diseases (including also topically treated autoimmune diseases such as atopic dermatitis).
- Latent bleeding risk (diabetic retinopathy, history of gastrointestinal bleeding due to e.g. ulcers), inherited or acquired coagulopathies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAY3283142Oral administration | Drug | Up-titration Scheme 1, Up-titration Scheme 2, Up-titration Scheme 3 |
| Placebo to BAY3283142Oral administration | Drug | Up-titration Scheme 1, Up-titration Scheme 2, Up-titration Scheme 3 |
Primary outcome
Number of participants with treatment-emergent adverse events per treatment arm
Time frame: Up to 7 days after end of treatment with study intervention
8 secondary outcomes
Area under the concentration versus time curve in a dosing interval (AUCτ) after single dose of BAY3283142 on Day 1
Time frame: Up to 24 hours post-dose
AUCτ after single dose of BAY3283142 on Day 1 divided by dose (AUCτ/D)
Time frame: Up to 24 hours post-dose
Maximum observed drug concentration in measured matrix (Cmax) after single dose of BAY3283142 on Day 1
Time frame: Up to 24 hours post-dose
Cmax after single dose of BAY3283142 on Day 1 divided by dose (Cmax/D)
Time frame: Up to 24 hours post-dose
AUC in a dosing interval after multiple doses of BAY3283142 on Day 12 (AUCτ,md)
Time frame: Up to 24 hours post-dose
AUCτ,md after multiple doses of BAY3283142 on Day 12 divided by dose (AUCτ,md/D)
Time frame: Up to 24 hours post-dose
Maximum observed drug concentration in measured matrix after multiple doses of BAY3283142 on Day 12 (Cmax,md)
Time frame: Up to 24 hours post-dose
Cmax,md after multiple doses of BAY3283142 on Day 12 divided by dose (Cmax,md/D)
Time frame: Up to 24 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Related trials for Chronic Kidney Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY3283142 in people with Chronic Kidney Disease and Hypertension, run by Bayer at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-emergent adverse events per treatment arm (time frame: Up to 7 days after end of treatment with study intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.