Chronic Kidney DiseasePhase 1NCT06402721
A Study to Learn About How BAY 3283142 Moves Into, Through, and Out of the Body After a Single Dose in Participants With Reduced Liver Function Compared to Participants With Normal Liver Function
A Phase 1 study testing BAY3283142 in people with Chronic Kidney Disease and Hepatic Impairment, run by Bayer at 1 site in United States.
Trial summary
Researchers are looking for a better way to treat people who have chronic kidney disease (CKD). CKD is a condition in which the kidneys' ability to work properly gradually decreases over time. The kidneys help the body get rid of waste through urine and filter the blood before sending it back to the heart. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease, Hepatic Impairment
- What is being tested?
- BAY3283142
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2024to 24 Feb 2025
- 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 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant must be 18 to 79 years (both inclusive) at the screening visit
- Participants with hepatic impairment classified as Child-Pugh A or B
- Disease confirmed by histopathology, (e.g. previous liver biopsy), laparoscopy, CT, MRI, ultrasound or fibroscan
- Stable liver disease in the last 2 months
- Participants who have normal hepatic function and are overtly healthy.
- Body mass index (BMI): 18 to 36 kg/m*2 (both inclusive).
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- Male or female. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Male participants: Must agree to use contraception/barrier as detailed below:
- Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.
- Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person.
- Female participants: A female participant is eligible to participate if she is not pregnant or breast feeding, and one of the following conditions applies:
- Is a woman of nonchildbearing potential (WONCBP)
- Is a women of childbearing potential (WOCBP) and using a contraceptive method that is highly effective (with a failure rate < 1% per year), with low user dependency, starting from signing the informed consent form and for at least 10 days after the intake of study intervention. The investigator should evaluate the potential for contraceptive method failure (e.g. noncompliance, recently initiated) in relationship to the dose of study intervention.
- A WOCBP must have a negative highly sensitive pregnancy test within 24h before the first dose of study intervention.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Who cannot join
- Severe ascites of more than 6 L (estimated by ultrasound)
- Evidence of hepatic encephalopathy related to chronic liver disease > grade 2 (exclusion by Number Connection Test).
- Renal failure with an estimated glomerular filtration rate ≤40 mL/min (according to CKD-EPI equation).
- Relevant diseases within the last 4 weeks prior to first study drug intervention.
- Acute diarrhea or constipation within 14 days before the predicted first dosing day.
- Febrile illness within 2 weeks prior to the admission of the study center
- Tendency for vasovagal reactions (e.g. after venipuncture) or syncope.
Trial locations and contacts
1 site in 1 country.
United States1 site
Orlando Clinical Research Center (OCRC)
Orlando, Florida, 32809-3017
About this study
Official title: An Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of BAY 3283142 in Participants With Impaired Hepatic Function (Classified as Child-Pugh A or B) in Comparison to Matched Controls With Normal Hepatic Function
Researchers are looking for a better way to treat people who have chronic kidney disease (CKD).
CKD is a condition in which the kidneys' ability to work properly gradually decreases over time. The kidneys help the body get rid of waste through urine and filter the blood before sending it back to the heart. When kidney function decreases, waste builds up in the body, which can cause various complications.
Read more
The study treatment, BAY 3283142, is under development to treat CKD. It works by activating 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. BAY3283142 is broken down in the liver by a specific enzyme before it is removed from the body.
In this study, researchers want to understand how a mild or moderate reduction in liver function affects the blood levels of BAY3283142.
The main purpose of this study is to learn how BAY3283142 moves into, through, and out of the body, after a single dose of BAY3283142 in participants with reduced liver function.
For this, the researchers will analyze:
- Area under the curve (AUC): a measure of the total amount of BAY3283142 in participants' blood over time
- Maximum observed concentration (Cmax): the highest amount of BAY 3283142 in participants' blood The AUC and Cmax values for participants with reduced liver function will be compared with the values for participants with normal liver function.
The study participants will be assigned to one of the four treatment groups based on their liver function:
- Group 1: participants with mild reduction in liver function
- Group 2: participants with moderate reduction in liver function
- Groups 3 and 4: participants with normal liver function who will be matched for age, weight, and gender with participants with reduced liver function All participants will take a single dose of BAY3283142 as a tablet by mouth without food.
Each participant will be in the study for around 5 to 6 weeks, which includes:
- a visit within 28 days of starting treatment to confirm if the participant can take part in this study
- a hospital stay for 7 days during which the participant will be given a single dose of BAY3283142 and the study doctor will monitor the participant's health
- a visit after 7 to 10 days of taking BAY3283142 during which the study doctor will perform a health check-up on the participant
During the study, the doctors and their study team will:
- check participants' health by performing tests such as blood and urine tests, blood pressure measurements, and checking 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, irrespective of whether they think it is related or not to the study treatment.
Access to study treatment after the end of this study is not planned. Participants with liver problems can continue taking their other prescribed medicines as usual.
- Conditions
- Chronic Kidney Disease, Hepatic Impairment
- Being tested
- BAY3283142
- Keywords
- CKD
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY3283142Drug
Single oral dose.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Mild hepatic impairment | Experimental | Participants with mild hepatic impairment. Receives: Drug: BAY3283142 |
| Group 2: Moderate hepatic impairment | Experimental | Participants with moderate hepatic impairment. Receives: Drug: BAY3283142 |
| Group 3 and 4: Normal hepatic function (control group) | Experimental | Control group(s) of age-, weight-, and gender-matched participants with normal hepatic function. Receives: Drug: BAY3283142 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) of BAY3283142
AUC(0-tlast) will be used as main parameter, if mean AUC cannot be reliably determined in all participants.
Measured: On Day 1 (dosing day), Day 2, Day 3, Day 4, Day 5, and Day 6.
Maximum observed drug concentration (Cmax) of BAY3283142
Measured: On Day 1 (dosing day), Day 2, Day 3, Day 4, Day 5, and Day 6.
Secondary outcomes (1)
Number of participants with treatment-emergent adverse events
Measured: 7 days after last administration of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start17 May 2024
- Primary completion24 Feb 2025
- Study completion24 Feb 2025
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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402721
- Sponsor's protocol ID
- 22129
- Status last verified
- Mar 2025
- First submitted
- 3 May 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of BAY 3283142 in Participants With Impaired Hepatic Function (Classified as Child-Pugh A or B) in Comparison to Matched Controls With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT06402721
- Acronym / sponsor ID
- 22129
- Conditions
- Chronic Kidney Disease, Hepatic Impairment
- Keywords
- CKD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 17 May 2024 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 7 May 2024 (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).
CKD is a condition in which the kidneys' ability to work properly gradually decreases over time. The kidneys help the body get rid of waste through urine and filter the blood before sending it back to the heart. When kidney function decreases, waste builds up in the body, which can cause various complications.
The study treatment, BAY 3283142, is under development to treat CKD. It works by activating 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. BAY3283142 is broken down in the liver by a specific enzyme before it is removed from the body.
In this study, researchers want to understand how a mild or moderate reduction in liver function affects the blood levels of BAY3283142.
The main purpose of this study is to learn how BAY3283142 moves into, through, and out of the body, after a single dose of BAY3283142 in participants with reduced liver function.
For this, the researchers will analyze:
- Area under the curve (AUC): a measure of the total amount of BAY3283142 in participants' blood over time
- Maximum observed concentration (Cmax): the highest amount of BAY 3283142 in participants' blood The AUC and Cmax values for participants with reduced liver function will be compared with the values for participants with normal liver function.
The study participants will be assigned to one of the four treatment groups based on their liver function:
- Group 1: participants with mild reduction in liver function
- Group 2: participants with moderate reduction in liver function
- Groups 3 and 4: participants with normal liver function who will be matched for age, weight, and gender with participants with reduced liver function All participants will take a single dose of BAY3283142 as a tablet by mouth without food.
Each participant will be in the study for around 5 to 6 weeks, which includes:
- a visit within 28 days of starting treatment to confirm if the participant can take part in this study
- a hospital stay for 7 days during which the participant will be given a single dose of BAY3283142 and the study doctor will monitor the participant's health
- a visit after 7 to 10 days of taking BAY3283142 during which the study doctor will perform a health check-up on the participant
During the study, the doctors and their study team will:
- check participants' health by performing tests such as blood and urine tests, blood pressure measurements, and checking 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, irrespective of whether they think it is related or not to the study treatment.
Access to study treatment after the end of this study is not planned. Participants with liver problems can continue taking their other prescribed medicines as usual.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Mild hepatic impairment | Experimental | Drug: BAY3283142Participants with mild hepatic impairment. |
| Group 2: Moderate hepatic impairment | Experimental | Drug: BAY3283142Participants with moderate hepatic impairment. |
| Group 3 and 4: Normal hepatic function (control group) | Experimental | Drug: BAY3283142Control group(s) of age-, weight-, and gender-matched participants with normal hepatic function. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Participant must be 18 to 79 years (both inclusive) at the screening visit
- Participants with hepatic impairment classified as Child-Pugh A or B
- Participants who have normal hepatic function and are overtly healthy.
- Body mass index (BMI): 18 to 36 kg/m*2 (both inclusive).
- Male or female. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Key exclusion criteria (7 listed)
- Severe ascites of more than 6 L (estimated by ultrasound)
- Evidence of hepatic encephalopathy related to chronic liver disease > grade 2 (exclusion by Number Connection Test).
- Renal failure with an estimated glomerular filtration rate ≤40 mL/min (according to CKD-EPI equation).
- Relevant diseases within the last 4 weeks prior to first study drug intervention.
- Acute diarrhea or constipation within 14 days before the predicted first dosing day.
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 |
|---|---|---|
| BAY3283142Single oral dose. | Drug | Group 1: Mild hepatic impairment, Group 2: Moderate hepatic impairment, Group 3 and 4: Normal hepatic function (control group) |
Primary outcome
Area under the curve (AUC) of BAY3283142
Time frame: On Day 1 (dosing day), Day 2, Day 3, Day 4, Day 5, and Day 6.
AUC(0-tlast) will be used as main parameter, if mean AUC cannot be reliably determined in all participants.
Maximum observed drug concentration (Cmax) of BAY3283142
Time frame: On Day 1 (dosing day), Day 2, Day 3, Day 4, Day 5, and Day 6.
1 secondary outcome
Number of participants with treatment-emergent adverse events
Time frame: 7 days after last administration of study drug
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 12 Mar 2025.
- 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
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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.
1 site in 1 country: 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 Hepatic Impairment, run by Bayer at 1 site in United States.
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 15 inclusion and 7 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 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Area under the curve (AUC) of BAY3283142 (time frame: On Day 1 (dosing day), Day 2, Day 3, Day 4, Day 5, and Day 6.). The study lists 2 primary outcomes in all. 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 12 Mar 2025.