Chronic Kidney DiseasePhase 1NCT05515432

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

A Phase 1 study testing Single oral dose of BAY3283142 IR (immediate release) tablet in people with Chronic Kidney Disease and Renal Impairment, run by Bayer at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 82 years
Conditions the study is for: Chronic Kidney Disease, Renal Impairment, Healthy Volunteers
What is being tested?: Single oral dose of BAY3283142 IR (immediate release) tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteGermany
Study dates: 11 Aug 2022to 6 Jun 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 18 to 82 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant must be 18 to 82 years of age inclusive, at the time of signing the informed consent.
Normal kidney function or at different stages of renal impairment (mild to severe renal impairment, ESRD with hemodialysis or hemodiafiltration).
Race: White (Note: Clinical Data Interchange Standards Consortium [CDISC] definition of White: Denotes a person with European, Middle Eastern, or North African ancestral origin who identifies, or is identified, as White [FDA]).
Body mass index (BMI) within the range 18.0 and 35.0 kg/m^2 (both inclusive).
Body weight equal or above 55 kg.
Male or female participants; women have to be of non-childbearing potential as defined in Section 10.4.1 (e.g., postmenopausal for at least 1 year, women with bilateral salpingectomy, women with bilateral ovariectomy, and women with hysterectomy).

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Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Men must agree to use a condom in sexual intercourse with female partner of childbearing potential and not to act as sperm donor for 10 days after dosing.
eGFR <90 mL/min/1.73 m^2 alculated by the CKD-EPI formula (eGFR must be repeated if screening period >10 days before dosing) 21 to 2 days prior to dosing and patients with ESRD on hemodialysis or hemodiafiltration.
Stable renal function (e.g., a serum creatinine value determined at least 3 months before the screening visit should not vary by more than 25% from the serum creatinine value determined at the screening visit).
eGFR ≥90 mL/min/1.73 m^2 calculated by the CKD-EPI formula (eGFR must be repeated if screening period >10 days before dosing) 21 to 2 days prior to dosing.
Needs to be within the required matching age, gender, and body weight range.

Who cannot join

Women of childbearing potential, pregnant or lactating women.
Medical disorder, condition, or history of such that would impair the participant's ability to participate or complete this study in the opinion of the investigator.
Known or suspected liver disorders (including Morbus Gilbert/Meulengracht) and bile secretion/flow (cholestasis).
Known hypersensitivity to the study drugs (active substances or excipients of the preparations).
Known severe allergies (e.g., allergies to more than 3 allergens, allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids), urticaria, or significant non-allergic drug reactions.
Relevant acute diseases within the last 4 weeks prior to intake of study intervention.

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Febrile illness within 2 weeks before intake of study intervention.
Known tendency for vasovagal reactions (e.g., after venipuncture) or clinically relevant history of syncope.
History of gastrointestinal surgery, with the exception of appendectomy unless it had been performed within the previous 12 months before screening.
Acute diarrhea or constipation within 14 days before intake of study intervention.
Diagnosed malignancy within the past 5 years with exception of completely resected basal cell cancer of the skin (excision >6 months before screening).
Planned intervention or surgery during the study which might impact the study objectives.
History of clinically relevant bleeding within the past 3 months.
Thrombotic disorder.
Use of systemic or topical medicines or substances which oppose the study objectives
Regular use of therapeutic or recreational drugs, e.g., carnitine products, anabolics, high dose vitamins (except for indicated medications for renally impaired).
Use of any herbal products or St. John's Wort within the last 14 days before intake of study intervention.
Excluded therapies (e.g., physiotherapy, acupuncture, etc.) within 1 week before intake of study intervention.
Change in chronic medications less than 2 weeks prior to dosing.
Participation in another clinical study during the preceding 3 months for multiple dose studies and 1 month for single dose studies (last visit of participant to previous study to first treatment of new study).
Exclusion periods from other studies or simultaneous participation in other clinical studies.
Previous treatment during this study (allowing previously treated participants to be re-included into the study may lead to bias).
Clinically relevant findings in the physical examination.
Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV) (and with a positive polymerase chain reaction [PCR] result or increased liver transaminases or other signs of liver disease), HIV antibodies 1+2/HIV p24 antigen (HIV-1/2 combi test).
Positive urine/mouth swab drug screening indicating drug abuse.
Positive alcohol breath test.
Special diets preventing the participants from eating the standard meals during the study.
Physical exercise within 96 h before admission the study site.
Regular daily consumption of more than 1 L of methylxanthine-containing food or beverages.
Consumption of methylxanthine-containing beverages or food (e.g., coffee, tea, cola drinks, and chocolate) within 48 h before intake of study intervention.
Smoking more than 10 cigarettes per day.
Regular daily consumption of more than 500 mL (male participants) or 250 mL (female participants) of usual beer or the equivalent quantity of approximately 20 g (male participants) or 10 g (female participants) of alcohol in another form.
Intake of foods or beverages containing alcohol within 96 h before intake of study intervention.
Donation of more than 100 mL of whole blood or plasma within 4 weeks or 500 mL whole blood within 3 months before intake of study intervention.
Plasmapheresis within 3 months prior to study intervention.
Suspicion of drug or alcohol abuse.

Trial locations and contacts

1 site in 1 country.

Germany1 site

CRS Clinical-Research-Services Kiel GmbH
Kiel, Schleswig-Holstein, 24105

Other trials in Germany

About this study

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

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.

Conditions: Chronic Kidney Disease, Renal Impairment, Healthy Volunteers
Being tested: Single oral dose of BAY3283142 IR (immediate release) tablet
Medical subject headings: Renal Insufficiency, Chronic, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Single oral dose of BAY3283142 IR (immediate release) tabletDrug
Single oral dose of BAY3283142 in participants with renal impairment compared to an age, gender and weight matched control group in an open-label study design

Study groups in NCT05515432
Study group	Role	What they receive
Mildly impaired renal funtion: eGFR (mL/min/1.73 m^2) ≥60 - <90	Experimental	Participants with renal impairment Receives: Drug: Single oral dose of BAY3283142 IR (immediate release) tablet
Moderately impaired renal funtion: eGFR (mL/min/1.73 m^2) ≥30 - <60	Experimental	Participants with renal impairment Receives: Drug: Single oral dose of BAY3283142 IR (immediate release) tablet
Severely impaired renal funtion: eGFR (mL/min/1.73 m^2) <30	Experimental	Participants with renal impairment Receives: Drug: Single oral dose of BAY3283142 IR (immediate release) tablet
ESRD (end stage renal disease) on dialysis	Experimental	Participants with renal impairment Receives: Drug: Single oral dose of BAY3283142 IR (immediate release) tablet
Normal renal function (control group): eGFR (mL/min/1.73 m^2) ≥90	Experimental	Age-, weight-, and gender-matched participants with normal renal function as control group Receives: Drug: Single oral dose of BAY3283142 IR (immediate release) tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

AUC of BAY3283142
AUC(0-tlast) will be used as main parameters if AUC cannot be reliably determined in all participants
Measured: up to 0 - 96 hours post-dose
AUCu of BAY3283142
AUC(0-tlast)u will be used as main parameters if AUC cannot be reliably determined in all participants
Measured: up to 0 - 96 hours post-dose
Cmax of BAY3283142
Measured: up to 0 - 96 hours post-dose
Cmax,u of BAY3283142
Measured: up to 0 - 96 hours post-dose

Secondary outcomes (1)

Number of participants with treatment-emergent adverse events (TEAEs) after intake of BAY3283142
Measured: up to 7 days post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Aug 20226 Jun 2023

First posted25 Aug 2022
Study start11 Aug 2022
Primary completion7 Mar 2023
Study completion6 Jun 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05515432
Sponsor's protocol ID: 21593
Other IDs: 2022-000858-28
Status last verified: Aug 2023
First submitted: 28 Jul 2022
Last updated: 21 Aug 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Kidney Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05515432
Acronym / sponsor ID: 21593
Conditions: Chronic Kidney Disease, Renal Impairment, Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: 11 Aug 2022 (actual)
Primary completion: 7 Mar 2023 (actual)
Study completion: 6 Jun 2023 (actual)
First posted: 25 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).

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.

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.

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Mildly impaired renal funtion: eGFR (mL/min/1.73 m^2) ≥60 - <90	Experimental	Drug: Single oral dose of BAY3283142 IR (immediate release) tabletParticipants with renal impairment
Moderately impaired renal funtion: eGFR (mL/min/1.73 m^2) ≥30 - <60	Experimental	Drug: Single oral dose of BAY3283142 IR (immediate release) tabletParticipants with renal impairment
Severely impaired renal funtion: eGFR (mL/min/1.73 m^2) <30	Experimental	Drug: Single oral dose of BAY3283142 IR (immediate release) tabletParticipants with renal impairment
ESRD (end stage renal disease) on dialysis	Experimental	Drug: Single oral dose of BAY3283142 IR (immediate release) tabletParticipants with renal impairment
Normal renal function (control group): eGFR (mL/min/1.73 m^2) ≥90	Experimental	Drug: Single oral dose of BAY3283142 IR (immediate release) tabletAge-, weight-, and gender-matched participants with normal renal function as control group

Who may qualify

Ages: 18 to 82 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Participant must be 18 to 82 years of age inclusive, at the time of signing the informed consent.
Normal kidney function or at different stages of renal impairment (mild to severe renal impairment, ESRD with hemodialysis or hemodiafiltration).
Race: White (Note: Clinical Data Interchange Standards Consortium [CDISC] definition of White: Denotes a person with European, Middle Eastern, or North African ancestral origin who identifies, or is identified, as White [FDA]).
Body mass index (BMI) within the range 18.0 and 35.0 kg/m^2 (both inclusive).
Body weight equal or above 55 kg.

Key exclusion criteria (36 listed)

Women of childbearing potential, pregnant or lactating women.
Medical disorder, condition, or history of such that would impair the participant's ability to participate or complete this study in the opinion of the investigator.
Known or suspected liver disorders (including Morbus Gilbert/Meulengracht) and bile secretion/flow (cholestasis).
Known hypersensitivity to the study drugs (active substances or excipients of the preparations).
Known severe allergies (e.g., allergies to more than 3 allergens, allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids), urticaria, or significant non-allergic drug reactions.

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
Single oral dose of BAY3283142 IR (immediate release) tabletSingle oral dose of BAY3283142 in participants with renal impairment compared to an age, gender and weight matched control group in an open-label study design	Drug	ESRD (end stage renal disease) on dialysis, Mildly impaired renal funtion: eGFR (mL/min/1.73 m^2) ≥60 - <90, Moderately impaired renal funtion: eGFR (mL/min/1.73 m^2) ≥30 - <60, Normal renal function (control group): eGFR (mL/min/1.73 m^2) ≥90, Severely impaired renal funtion: eGFR (mL/min/1.73 m^2) <30

Primary outcome

AUC of BAY3283142
Time frame: up to 0 - 96 hours post-dose
AUC(0-tlast) will be used as main parameters if AUC cannot be reliably determined in all participants
AUCu of BAY3283142
Time frame: up to 0 - 96 hours post-dose
AUC(0-tlast)u will be used as main parameters if AUC cannot be reliably determined in all participants
Cmax of BAY3283142
Time frame: up to 0 - 96 hours post-dose
Cmax,u of BAY3283142
Time frame: up to 0 - 96 hours post-dose

1 secondary outcome

Number of participants with treatment-emergent adverse events (TEAEs) after intake of BAY3283142
Time frame: up to 7 days 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 21 Aug 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
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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 Single oral dose of BAY3283142 IR (immediate release) tablet in people with Chronic Kidney Disease and Renal Impairment, run by Bayer at 1 site in Germany.

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 12 inclusion and 36 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 21 Aug 2023. 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 Germany. 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?

AUC of BAY3283142 (time frame: up to 0 - 96 hours post-dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05515432.

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 21 Aug 2023.