Worsening Chronic Heart FailurePhase 1NCT04881994
A Study to Learn How Finerenone (BAY94-8862) Moves Into, Through and Out of the Body, How it Affects the Body, and How Safe it is in Adult Participants With Different Degrees of Reduced Liver Function and in Healthy Participants With Similar Age, Weight and Gender Distribution
A Phase 1 study testing Finerenone (BAY94-8862) in people with Worsening Chronic Heart Failure and Diabetic Nephropathy, run by Bayer at 1 site in Germany.
Trial summary
Researchers are looking for a better way to treat people who have worsening of chronic heart failure, a long-term condition where the heart does not pump blood as well as it should, as well as to treat patients who have diabetic nephropathy, a long-term, progressive decrease in the kidneys' ability to work properly in… Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Worsening Chronic Heart Failure, Diabetic Nephropathy
- What is being tested?
- Finerenone (BAY94-8862)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteGermany
- Study dates
- 25 Mar 2014to 8 Dec 2014
- 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
- All participants
- The informed consent must be signed before any study specific tests or procedures are done;
- Male and female white participants;
- Women of childbearing potential can only be included in the study if a pregnancy test is negative. Women of childbearing potential must agree to use adequate contraception when sexually active. 'Adequate contraception' is defined as any combination of at least 2 effective methods of birth control, of which at least one is a physical barrier (e.g. condoms with hormonal contraception or implants or combined oral contraceptives, certain intrauterine devices). This applies from signing the informed consent form until follow up visit.
- Body mass index (BMI): 18 to 34 kg/m2 (both inclusive);
- Age: 18 to 79 years (both inclusive) at the screening visit;
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- Men must agree to use adequate contraception when being sexually active. This applies from signing of the informed consent until 12 weeks after the last study drug administration. 'Adequate contraception' is defined as any combination of at least 2 effective methods of birth control, of which at least one is a physical barrier (e.g. condoms with hormonal contraception or implants or combined oral contraceptives, certain intrauterine devices);
- Ability to understand and follow study-related instructions.
- Participants with hepatic impairment
- Participants with documented liver cirrhosis confirmed by histopathology, e.g., previous liver biopsy, laparoscopy, ultrasound, or fibroscan;
- Participants with hepatic impairment (Child Pugh A or B);
- Participants with stable liver disease in the last 2 months.
- Healthy participants
- Healthy male and female white participants;
- Mean age and body weight in the control group and in the two groups with hepatic impairment (Child Pugh A and B) should not vary by more than +/-10 years and +/-10 kg;
- Gender matched.
Who cannot join
- All participants
- Participants with a 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 or the sponsor;
- Medical history of Kock pouch (ileostomy after proctocolectomy);
- Febrile illness within 1 week prior to admission to study center;
- Relevant diseases within the last 4 weeks prior to admission;
- Known severe allergies, non-allergic drug reactions, or multiple drug allergies;
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- Known hypersensitivity to the study drugs;
- Participants with diagnosed malignancy within the past 5 years;
- Participants with psychiatric disorders which may disable the participants to consent;
- Use of the following co-medications from 2 weeks before until 4 days after study drug administration:
- CYP3A4 inducers (e.g. St. John´s wort, rifampicin, carbamazepin, phenytoin, phenobarbital, bosentan, efavirenz, etravirine, nevirapine)
- weak to moderate CYP3A4 inhibitors (e.g. grapefruit juice and other grapefruit containing products, erythromycin, saquinavir, amiodarone, verapamil, fluconazole, diltiazem)
- strong inhibitors of CYP3A4 (e.g. itraconazole, ketoconazol, posaconazole, voriconazole, atazanavir, ritonavir, nelfinavir or other inhibitors of human immunodeficiency virus (HIV) protease, clarithromycin, telithromycin, nefazodon, telaprevir, boceprevir) or
- gemfibrozil (a strong inhibitor of CYP2C8)
- Positive urine drug screening;
- For women of childbearing potential: positive pregnancy test;
- Positive results for human immunodeficiency virus 1 and 2 antibodies (HIV-Ag/Ab).
- Participants with hepatic impairment
- Severe cerebrovascular or cardiac disorders, e.g., myocardial infarction less than 6 months prior to dosing, congestive heart failure of New York Heart Association grade III or IV, severe arrhythmia requiring antiarrhythmic treatment;
- Evidence of hepatic encephalopathy related to chronic liver disease >grade 2 (exclusion by Number Connection Test (NCT);
- Participants with percutaneous transluminal coronary angioplasty or coronary artery bypass graft less than 6 months prior to study drug administration;
- History of bleeding within the past 3 months;
- Thrombotic disorder;
- Participants with diabetes mellitus with a glycohemoglobin A1c (HbA1c) >10%;
- Severe ascites of more than 6 L (estimated by ultrasound);
- Participants with primary and secondary biliary cirrhosis;
- Participants with sclerosing cholangitis;
- Failure of any other major organ system other than the liver;
- Severe infection, malignancy, or psychosis, or any clinically significant illness within 4 weeks prior to study drug administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Pharmacokinetics, Safety, and Tolerability of Finerenone (BAY 94-8862) in Subjects With Hepatic Impairment (Classified as Child Pugh A or B) and in Age-, Weight-, and Gender-matched Healthy Subjects Following a Single Oral Dose in a Single-center, Non-randomized, Non-controlled, Non-blinded, Observational Study With Group Stratification
Researchers are looking for a better way to treat people who have worsening of chronic heart failure, a long-term condition where the heart does not pump blood as well as it should, as well as to treat patients who have diabetic nephropathy, a long-term, progressive decrease in the kidneys' ability to work properly in patients with diabetes mellitus.
In this study researchers wanted to learn more about a new substance called finerenone (BAY94-8862). Finerenone is a substance that blocks the activation of a protein in the body called mineralocorticoid receptor (MR). An increased activation of MR is involved in the development of hypertension, organ damage and worsening of heart failure.
The researchers studied how finerenone moves into, through and out of the body. The researchers also looked at how safe finerenone is and how it affects the body. The main purpose of this study was to help researchers develop recommendations for the amount of the substance (the dosing) to be given to patients with reduced liver function.
- Being tested
- Finerenone (BAY94-8862)
- Keywords
- Child Pugh A, Child Pugh B, Liver impairment
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finerenone (BAY94-8862)Drug
Single oral dose of finerenone given as 5 mg immediate release (IR) tablet.
| Study group | Role | What they receive |
|---|---|---|
| Mild hepatic impairment (Child Pugh A) | Experimental | Participants with mild hepatic impairment (Child Pugh A) received single oral dose of finerenone. Receives: Drug: Finerenone (BAY94-8862) |
| Moderate hepatic impairment (Child Pugh B) | Experimental | Participants with moderate hepatic impairment (Child Pugh B) received single oral dose of finerenone. Receives: Drug: Finerenone (BAY94-8862) |
| Healthy participants | Experimental | Healthy age-, weight-, and gender- matched participants received single oral dose of finerenone. Receives: Drug: Finerenone (BAY94-8862) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration versus time curve from zero to infinity (AUC) of finerenone in plasma
Measured: 0 hour pre-dose to 96 hour post-dose
Area under the concentration versus time curve from zero to infinity of unbound finerenone (AUCu) in plasma
Measured: 0 hour pre-dose to 96 hour post-dose
Maximum observed drug concentration (Cmax) of finerenone in plasma
Measured: 0 hour pre-dose to 96 hour post-dose
Maximum observed drug concentration of unbound finerenone (Cmax,u) in plasma
Measured: 0 hour pre-dose to 96 hour post-dose
Secondary outcomes (1)
Number of participants with adverse events
Measured: From the start of study treatment up to 3 days after study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start25 Mar 2014
- Primary completion16 Sep 2014
- Study completion8 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Worsening Chronic Heart FailureStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881994
- Sponsor's protocol ID
- 14510
- Other IDs
- 2013-005089-21
- Status last verified
- Jul 2021
- First submitted
- 6 May 2021
- Last updated
- 16 Jul 2021
- 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.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.
Publications
Heinig R, Lambelet M, Nagelschmitz J, Alatrach A, Halabi A. Pharmacokinetics of the Novel Nonsteroidal Mineralocorticoid Receptor Antagonist Finerenone (BAY 94-8862) in Individuals with Mild or Moderate Hepatic Impairment. Eur J Drug Metab Pharmacokinet. 2019 Oct;44(5):619-628. doi: 10.1007/s13318-019-00547-x.
PubMed 30825073
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Pharmacokinetics, Safety, and Tolerability of Finerenone (BAY 94-8862) in Subjects With Hepatic Impairment (Classified as Child Pugh A or B) and in Age-, Weight-, and Gender-matched Healthy Subjects Following a Single Oral Dose in a Single-center, Non-randomized, Non-controlled, Non-blinded, Observational Study With Group Stratification
- ClinicalTrials.gov ID
- NCT04881994
- Acronym / sponsor ID
- 14510
- Keywords
- Child Pugh A, Child Pugh B, Liver impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2014 (actual)
- Primary completion
- 16 Sep 2014 (actual)
- Study completion
- 8 Dec 2014 (actual)
- First posted
- 11 May 2021 (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 worsening of chronic heart failure, a long-term condition where the heart does not pump blood as well as it should, as well as to treat patients who have diabetic nephropathy, a long-term, progressive decrease in the kidneys' ability to work properly in patients with diabetes mellitus.
In this study researchers wanted to learn more about a new substance called finerenone (BAY94-8862). Finerenone is a substance that blocks the activation of a protein in the body called mineralocorticoid receptor (MR). An increased activation of MR is involved in the development of hypertension, organ damage and worsening of heart failure.
The researchers studied how finerenone moves into, through and out of the body. The researchers also looked at how safe finerenone is and how it affects the body. The main purpose of this study was to help researchers develop recommendations for the amount of the substance (the dosing) to be given to patients with reduced liver function.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild hepatic impairment (Child Pugh A) | Experimental | Drug: Finerenone (BAY94-8862)Participants with mild hepatic impairment (Child Pugh A) received single oral dose of finerenone. |
| Moderate hepatic impairment (Child Pugh B) | Experimental | Drug: Finerenone (BAY94-8862)Participants with moderate hepatic impairment (Child Pugh B) received single oral dose of finerenone. |
| Healthy participants | Experimental | Drug: Finerenone (BAY94-8862)Healthy age-, weight-, and gender- matched participants received single oral dose of finerenone. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- All participants
- The informed consent must be signed before any study specific tests or procedures are done;
- Male and female white participants;
- Women of childbearing potential can only be included in the study if a pregnancy test is negative. Women of childbearing potential must agree to use adequate contraception when sexually active. 'Adequate contraception' is defined as any combination of at least 2 effective methods of birth control, of which at least one is a physical barrier (e.g. condoms with hormonal contraception or implants or combined oral contraceptives, certain intrauterine devices). This applies from signing the informed consent form until follow up visit.
- Body mass index (BMI): 18 to 34 kg/m2 (both inclusive);
Key exclusion criteria (29 listed)
- All participants
- Participants with a 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 or the sponsor;
- Medical history of Kock pouch (ileostomy after proctocolectomy);
- Febrile illness within 1 week prior to admission to study center;
- Relevant diseases within the last 4 weeks prior to admission;
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 |
|---|---|---|
| Finerenone (BAY94-8862)Single oral dose of finerenone given as 5 mg immediate release (IR) tablet. | Drug | Healthy participants, Mild hepatic impairment (Child Pugh A), Moderate hepatic impairment (Child Pugh B) |
Primary outcome
Area under the concentration versus time curve from zero to infinity (AUC) of finerenone in plasma
Time frame: 0 hour pre-dose to 96 hour post-dose
Area under the concentration versus time curve from zero to infinity of unbound finerenone (AUCu) in plasma
Time frame: 0 hour pre-dose to 96 hour post-dose
Maximum observed drug concentration (Cmax) of finerenone in plasma
Time frame: 0 hour pre-dose to 96 hour post-dose
Maximum observed drug concentration of unbound finerenone (Cmax,u) in plasma
Time frame: 0 hour pre-dose to 96 hour post-dose
1 secondary outcome
Number of participants with adverse events
Time frame: From the start of study treatment up to 3 days after study treatment
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 16 Jul 2021.
- Results publication: PubMed 30825073Heinig R, Lambelet M, Nagelschmitz J, Alatrach A, Halabi A. Pharmacokinetics of the Novel Nonsteroidal Mineralocorticoid Receptor Antagonist Finerenone (BAY 94-8862) in Individuals with Mild or Moderate Hepatic Impairment. Eur J Drug Metab Pharmacokinet. 2019 Oct;44(5):619-628. doi: 10.1007/s13318-019-00547-x.
- 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.
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.
Bayer Study Director study director
Bayer
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 Finerenone (BAY94-8862) in people with Worsening Chronic Heart Failure and Diabetic Nephropathy, 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 16 inclusion and 29 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 16 Jul 2021. 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?
Area under the concentration versus time curve from zero to infinity (AUC) of finerenone in plasma (time frame: 0 hour pre-dose to 96 hour 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 NCT04881994, which also lists 1 linked publication.
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 16 Jul 2021; AzTrials last refreshed its copy on 2 Nov 2026.