Worsening Chronic Heart FailurePhase 1NCT04908436
A Study to Learn How BAY94-8862 Moves Into, Through and Out of the Body, How Safe it is and How it Affects the Body in Adult Participants With Reduced Kidney 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 Chronic Kidney Disease, 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. In this study researchers wanted to learn more about a new substance called finerenone (BAY94-8862). 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, Chronic Kidney Disease
- 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
- 33 participants
- Where
- 1 siteGermany
- Study dates
- 27 Oct 2010to 27 Jan 2012
- 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
- The informed consent must be signed before any study specific tests or procedures are done;
- Male participants and female participants without childbearing potential (postmenopausal women with 12 month of spontaneous amenorrhea or with 6 month of spontaneous amenorrhea and serum follicle-stimulating hormone (FSH) levels >30 mIU/mL; women with 6 weeks post bilateral ovarectomy, women with bilateral tubal ligation, and women with hysterectomy);
- Age: 18 to 79 years at the first screening examination;
- Race: White;
- Body mass index (BMI): ≥ 18 and ≤ 34 kg / m2;
- Participants with renal impairment
Show all 10Show fewer
- Creatinine clearance (CLCR) ≤ 80 mL/min determined from a 24 hour urine collection interval 2 - 14 days prior to dosing;
- Stable renal disease, ie a serum creatinine value determined at least 3-6 months before the pre-study visit should not vary by more than 20% from the serum creatinine value determined at the pre-study visit;
- Healthy participants
- Mean age and body weight in Group 1 (control group, healthy participants) and Groups 2 - 4 should not vary by more than +/- 10 years and +/- 10 kg, respectively.
Who cannot join
- Participation in another clinical trial during the preceding 3 months for multiple dose studies and 1 month for single-dose studies; (final examination from previous study to first treatment of new study);
- Exclusion periods from other studies or simultaneous participation in other clinical studies;
- Donation of more than 100 mL of blood within 4 weeks before the first study drug administration or more than 500 mL in the preceding 3 months;
- Regular use of following medication during or within the 1 - 2 weeks preceding the study:
- concomitant administration of other Aldosterone-antagonists (eg. eplerenone or spironolactone), potassium-sparing diuretics, potassium supplements, nonsteroidal anti-inflammatory drugs like ASS (secondary prevention with a dose of 100 mg daily is allowed), indomethacin or ibuprofen
- concomitant use of cytochrome P450 isoenzyme 3A4 (CYP3A4) inducers (eg St. John´s wort, rifampicin, carbamazepin, phenytoin, phenobarbital, bosentan)
Show all 30Show fewer
- concomitant use of weak to moderate CYP3A4 inhibitors (eg erythromycin, quinupristin/dalfopristin, saquinavir, fluconazole, amiodarone, diltiazem, fluvoxamine, verapamil, valproic acid, fluoxetine, grapefruit juice)
- strong inhibitors of CYP3A4 (eg human immunodeficiency virus (HIV) protease inhibitors like indinavir, nelfinavir, ritonavir, atazanavir, lopinavir, amprenavir and saquinavir; macrolide/ketolide antibiotics like clarithromycin, telithromycin; antimycotic agents like itraconazole and ketoconazole [topical formulations will be allowed]; nefazodone)
- moderate and strong inhibitors of cytochrome P450 isoenzyme 2C8 (CYP2C8) (eg gemfibrozil, montelukast, trimethoprim, glitazones)
- Women of childbearing potential, pregnant or lactating women;
- Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV 1+2);
- Serum potassium level ≥ 5.5 mmol/L;
- Serum sodium level ≤ 130 mmol/L;
- For participants with renal impairment
- Acute renal failure;
- Acute nephritis;
- Any organ transplant;
- Failure of any other major organ system other than the kidney;
- Diastolic blood pressure (DBP) > 100 mmHg and/or systolic blood pressure (SBP) > 180 mmHg (at the pre-study examination; readings taken at the end of the dosing interval of antihypertensive medication, if any);
- Heart rate below 45 or above 110 BPM at screening visit;
- Hemoglobin < 8 g/dL;
- Serum albumin < 30 g/L;
- Severe cerebrovascular or cardiac disorders, eg myocardial infarction less than 6 months prior to dosing, congestive heart failure of New York Heart Association (NYHA) grade III or IV, decompensated heart failure, severe arrhythmia requiring antiarrhythmic treatment;
- For healthy participants
- A history of relevant diseases of vital organs, of the central nervous system or other organs;
- Systolic blood pressure below 100 mmHg or above 145 mmHg;
- Diastolic blood pressure above 95 mmHg;
- Heart rate below 45 or above 95 BPM at screening visit;
- Clinically relevant deviations of the screened laboratory parameters in clinical chemistry, hematology, or urinalysis from reference range;
- Relevant deviation from the normal range in the clinical examination as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Pharmacokinetics, Safety, and Tolerability of BAY 94-8862 in Male and Female Subjects With Renal Impairment and in Age- and Weight-matched Healthy Subjects Following a Single Oral Dose of 10 mg BAY 94-8862 IR Tablet 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.
In this study researchers wanted to learn more about a new substance called finerenone (BAY94-8862).
Read more
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. Many patients with worsening chronic heart failure also suffer from chronic kidney disease. Chronic kidney disease is a long-term decrease in the kidneys' ability to work properly.
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 kidney function.
- Being tested
- Finerenone (BAY94-8862)
- 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.
Finerenone (BAY94-8862)Drug
10 mg BAY94-8862 immediate release (IR) tablet, administered orally
| Study group | Role | What they receive |
|---|---|---|
| Normal renal function | Experimental | Healthy participants with creatinine clearance (CLCR) >80 mL/min received single oral dose of 10 mg BAY94-8862 as an IR tablet under fasting conditions. Receives: Drug: Finerenone (BAY94-8862) |
| Mild renal impairment | Experimental | Participants with CLCR 50-80 mL/min received single oral dose of 10 mg BAY94-8862 as an IR tablet under fasting conditions. Receives: Drug: Finerenone (BAY94-8862) |
| Moderate renal impairment | Experimental | Participants with CLCR 30-<50 mL/min received single oral dose of 10 mg BAY94-8862 as an IR tablet under fasting conditions. Receives: Drug: Finerenone (BAY94-8862) |
| Severe renal impairment | Experimental | Participants with CLCR <30 mL/min received single oral dose of 10 mg BAY94-8862 as an IR tablet under fasting conditions. 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 plasma concentration vs time curve from zero to infinity for total (bound and unbound) drug after single dose administration of BAY94-8862 (AUC)
AUC for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
Measured: Up to 96 hours post-dose
Maximum total (bound and unbound) drug concentration in plasma after single dose administration of BAY94-8862 (Cmax)
Cmax for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
Measured: Up to 96 hours post-dose
AUC for unbound drug (AUCu)
AUCu for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
Measured: Up to 96 hours post-dose
Cmax for unbound drug (Cmax,u)
Cmax,u BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
Measured: Up to 96 hours post-dose
AUC divided by dose per kg body weight (AUCnorm)
AUCnorm for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
Measured: Up to 96 hours post-dose
AUCnorm for unbound drug (AUCu,norm)
AUCu, norm for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
Measured: Up to 96 hours post-dose
Cmax divided by dose per body weight (Cmax,norm)
Cmax, norm for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
Measured: Up to 96 hours post-dose
Cmax,norm for unbound drug (Cmax,u,norm)
Cmax,u,norm for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
Measured: Up to 96 hours post-dose
Secondary outcomes (21)
Plasma renin activity (PRA)
Change from baseline in plasma renin activity
Measured: Prior to dosing and 12 hours post-dose
Plasma angiotensin II
Change from baseline in plasma angiotensin II
Measured: Prior to dosing and 12 hours post-dose
Serum aldosterone
Change from baseline in serum aldosterone
Measured: Prior to dosing and 12 hours post-dose
Plasminogen activator inhibitor-1 (PAI-1)
Change from baseline in PAI-1
Measured: Prior to dosing and 12 hours post-dose
Urinary volume
Change in volume of urine excreted
Measured: Prior to dosing up to 24 hours post-dose
Urinary creatinine
Change in urine creatinine concentrations
Measured: Prior to dosing up to 24 hours post-dose
Urinary electrolytes
Change in urinary electrolytes
Measured: Prior to dosing up to 24 hours post-dose
Half-life associated with the terminal slope (t½)
t½ for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
Measured: Up to 96 hours post-dose
Fraction unbound (fu)
fu for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
Measured: 1 hour and 6 hours post-dose
AUC divided by dose (AUC/D)
AUC/D for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
Measured: Up to 96 hours post-dose
AUC from time 0 to the last data point (AUC(0-tlast))
AUC(0-tlast) for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
Measured: Up to 96 hours post-dose
Cmax divided by dose (Cmax/D)
Cmax/D for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
Measured: Up to 96 hours post-dose
Time to reach Cmax (tmax)
Time to reach Cmax (in case of two identical Cmax values, the first tmax was to be used) for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
Measured: Up to 96 hours post-dose
Mean residence time (MRT)
MRT for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
Measured: Up to 96 hours post-dose
Total body clearance of drug calculated after extravascular administration (CL/F)
CL/F for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
Measured: Up to 96 hours post-dose
Total body clearance of unbound drug from plasma calculated after oral administration (apparent oral unbound clearance) (CLu/F)
CLu/F for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
Measured: Up to 96 hours post-dose
Apparent volume of distribution during terminal phase after extravascular administration (Vz/F)
Vz/F for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
Measured: Up to 96 hours post-dose
Amount excreted into urine from 0 to 96 h (end of urine sampling) after study drug administration (AE,ur)
AE,ur for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
Measured: Up to 96 hours post-dose
Percent amount excreted into urine from 0 to 96 h (end of urine sampling) after study drug administration (%AE,ur)
%AE,ur for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
Measured: Up to 96 hours post-dose
Renal body clearance of drug (CLR)
CLR of BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
Measured: Up to 96 hours post-dose
Number of participants with adverse events
Measured: Approximately 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start27 Oct 2010
- Primary completion5 May 2011
- Study completion27 Jan 2012
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
- 33 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
- NCT04908436
- Sponsor's protocol ID
- 14509
- Other IDs
- 2010-022321-16
- Status last verified
- Jan 2022
- First submitted
- 27 May 2021
- Last updated
- 28 Jan 2022
- 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, Kimmeskamp-Kirschbaum N, Halabi A, Lentini S. Pharmacokinetics of the Novel Nonsteroidal Mineralocorticoid Receptor Antagonist Finerenone (BAY 94-8862) in Individuals With Renal Impairment. Clin Pharmacol Drug Dev. 2016 Nov;5(6):488-501. doi: 10.1002/cpdd.263. Epub 2016 Jul 18.
PubMed 27431783
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Pharmacokinetics, Safety, and Tolerability of BAY 94-8862 in Male and Female Subjects With Renal Impairment and in Age- and Weight-matched Healthy Subjects Following a Single Oral Dose of 10 mg BAY 94-8862 IR Tablet in a Single-center, Non-randomized, Non-controlled, Non-blinded, Observational Study With Group Stratification
- ClinicalTrials.gov ID
- NCT04908436
- Acronym / sponsor ID
- 14509
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2010 (actual)
- Primary completion
- 5 May 2011 (actual)
- Study completion
- 27 Jan 2012 (actual)
- First posted
- 1 Jun 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.
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. Many patients with worsening chronic heart failure also suffer from chronic kidney disease. Chronic kidney disease is a long-term decrease in the kidneys' ability to work properly.
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 kidney function.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal renal function | Experimental | Drug: Finerenone (BAY94-8862)Healthy participants with creatinine clearance (CLCR) >80 mL/min received single oral dose of 10 mg BAY94-8862 as an IR tablet under fasting conditions. |
| Mild renal impairment | Experimental | Drug: Finerenone (BAY94-8862)Participants with CLCR 50-80 mL/min received single oral dose of 10 mg BAY94-8862 as an IR tablet under fasting conditions. |
| Moderate renal impairment | Experimental | Drug: Finerenone (BAY94-8862)Participants with CLCR 30-<50 mL/min received single oral dose of 10 mg BAY94-8862 as an IR tablet under fasting conditions. |
| Severe renal impairment | Experimental | Drug: Finerenone (BAY94-8862)Participants with CLCR <30 mL/min received single oral dose of 10 mg BAY94-8862 as an IR tablet under fasting conditions. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The informed consent must be signed before any study specific tests or procedures are done;
- Male participants and female participants without childbearing potential (postmenopausal women with 12 month of spontaneous amenorrhea or with 6 month of spontaneous amenorrhea and serum follicle-stimulating hormone (FSH) levels >30 mIU/mL; women with 6 weeks post bilateral ovarectomy, women with bilateral tubal ligation, and women with hysterectomy);
- Age: 18 to 79 years at the first screening examination;
- Race: White;
- Body mass index (BMI): ≥ 18 and ≤ 34 kg / m2;
Key exclusion criteria (30 listed)
- Participation in another clinical trial during the preceding 3 months for multiple dose studies and 1 month for single-dose studies; (final examination from previous study to first treatment of new study);
- Exclusion periods from other studies or simultaneous participation in other clinical studies;
- Donation of more than 100 mL of blood within 4 weeks before the first study drug administration or more than 500 mL in the preceding 3 months;
- Regular use of following medication during or within the 1 - 2 weeks preceding the study:
- Women of childbearing potential, pregnant or lactating women;
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)10 mg BAY94-8862 immediate release (IR) tablet, administered orally | Drug | Mild renal impairment, Moderate renal impairment, Normal renal function, Severe renal impairment |
Primary outcome
Area under the plasma concentration vs time curve from zero to infinity for total (bound and unbound) drug after single dose administration of BAY94-8862 (AUC)
Time frame: Up to 96 hours post-dose
AUC for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
Maximum total (bound and unbound) drug concentration in plasma after single dose administration of BAY94-8862 (Cmax)
Time frame: Up to 96 hours post-dose
Cmax for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
AUC for unbound drug (AUCu)
Time frame: Up to 96 hours post-dose
AUCu for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
Cmax for unbound drug (Cmax,u)
Time frame: Up to 96 hours post-dose
Cmax,u BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
AUC divided by dose per kg body weight (AUCnorm)
Time frame: Up to 96 hours post-dose
AUCnorm for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
AUCnorm for unbound drug (AUCu,norm)
Time frame: Up to 96 hours post-dose
AUCu, norm for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
Cmax divided by dose per body weight (Cmax,norm)
Time frame: Up to 96 hours post-dose
Cmax, norm for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
Cmax,norm for unbound drug (Cmax,u,norm)
Time frame: Up to 96 hours post-dose
Cmax,u,norm for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)
21 secondary outcomes
Plasma renin activity (PRA)
Time frame: Prior to dosing and 12 hours post-dose
Plasma angiotensin II
Time frame: Prior to dosing and 12 hours post-dose
Serum aldosterone
Time frame: Prior to dosing and 12 hours post-dose
Plasminogen activator inhibitor-1 (PAI-1)
Time frame: Prior to dosing and 12 hours post-dose
Urinary volume
Time frame: Prior to dosing up to 24 hours post-dose
Urinary creatinine
Time frame: Prior to dosing up to 24 hours post-dose
Urinary electrolytes
Time frame: Prior to dosing up to 24 hours post-dose
Half-life associated with the terminal slope (t½)
Time frame: Up to 96 hours post-dose
Fraction unbound (fu)
Time frame: 1 hour and 6 hours post-dose
AUC divided by dose (AUC/D)
Time frame: Up to 96 hours post-dose
AUC from time 0 to the last data point (AUC(0-tlast))
Time frame: Up to 96 hours post-dose
Cmax divided by dose (Cmax/D)
Time frame: Up to 96 hours post-dose
Time to reach Cmax (tmax)
Time frame: Up to 96 hours post-dose
Mean residence time (MRT)
Time frame: Up to 96 hours post-dose
Total body clearance of drug calculated after extravascular administration (CL/F)
Time frame: Up to 96 hours post-dose
Total body clearance of unbound drug from plasma calculated after oral administration (apparent oral unbound clearance) (CLu/F)
Time frame: Up to 96 hours post-dose
Apparent volume of distribution during terminal phase after extravascular administration (Vz/F)
Time frame: Up to 96 hours post-dose
Amount excreted into urine from 0 to 96 h (end of urine sampling) after study drug administration (AE,ur)
Time frame: Up to 96 hours post-dose
Percent amount excreted into urine from 0 to 96 h (end of urine sampling) after study drug administration (%AE,ur)
Time frame: Up to 96 hours post-dose
Renal body clearance of drug (CLR)
Time frame: Up to 96 hours post-dose
Number of participants with adverse events
Time frame: Approximately 5 weeks
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 28 Jan 2022.
- Results publication: PubMed 27431783Heinig R, Kimmeskamp-Kirschbaum N, Halabi A, Lentini S. Pharmacokinetics of the Novel Nonsteroidal Mineralocorticoid Receptor Antagonist Finerenone (BAY 94-8862) in Individuals With Renal Impairment. Clin Pharmacol Drug Dev. 2016 Nov;5(6):488-501. doi: 10.1002/cpdd.263. Epub 2016 Jul 18.
- 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.
Related trials for Worsening Chronic Heart Failure
Not yet recruitingObservational study
Biomarker Panel Development for Early Identification of Worsening Heart Failure and Improved Post-acute Care
Outpatients With Chronic Heart Failure, Heart Failure Chronic
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Vericiguat is and How Well it Works in Indian People With Chronic Heart Failure With Reduced Ejection Fraction and Worsening Chronic Heart Failure Under Real World Conditions
Chronic Heart Failure With Reduced Ejection Fraction, Worsening Chronic Heart Failure
Recruiting
Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD
Acute on Chronic Systolic Congestive Heart Failure, Cardiorenal Syndrome
RecruitingObservational study
Depressive Symptoms, Cognitive Impairment, and Outcomes in Hospitalized Chronic Heart Failure Patients
Congestive Heart Failure Chronic, Cognitive Impairment, Mild
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 Chronic Kidney Disease, 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 10 inclusion and 30 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 28 Jan 2022. 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 plasma concentration vs time curve from zero to infinity for total (bound and unbound) drug after single dose administration of BAY94-8862 (AUC) (time frame: Up to 96 hours post-dose). The study lists 8 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 NCT04908436, 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 28 Jan 2022.