check_circleStudy Completed
Worsening chronic heart failure, Chronic kidney disease
Bayer Identifier:
14509
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
Trial purpose
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.
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.
Key Participants Requirements
Sex
BothAge
18 - 79 YearsTrial summary
Enrollment Goal
33Trial Dates
October 2010 - January 2012Phase
Phase 1Could I Receive a placebo
NoProducts
Finerenone (BAY94-8862)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Kiel, 24105, Germany |
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)AUC for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)date_rangeTime Frame:Up to 96 hours post-doseenhanced_encryptionNoSafety Issue:
- 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)date_rangeTime Frame:Up to 96 hours post-doseenhanced_encryptionNoSafety Issue:
- AUC for unbound drug (AUCu)AUCu for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)date_rangeTime Frame:Up to 96 hours post-doseenhanced_encryptionNoSafety Issue:
- Cmax for unbound drug (Cmax,u)Cmax,u BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)date_rangeTime Frame:Up to 96 hours post-doseenhanced_encryptionNoSafety Issue:
- AUC divided by dose per kg body weight (AUCnorm)AUCnorm for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)date_rangeTime Frame:Up to 96 hours post-doseenhanced_encryptionNoSafety Issue:
- AUCnorm for unbound drug (AUCu,norm)AUCu, norm for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)date_rangeTime Frame:Up to 96 hours post-doseenhanced_encryptionNoSafety Issue:
- Cmax divided by dose per body weight (Cmax,norm)Cmax, norm for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)date_rangeTime Frame:Up to 96 hours post-doseenhanced_encryptionNoSafety Issue:
- Cmax,norm for unbound drug (Cmax,u,norm)Cmax,u,norm for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)date_rangeTime Frame:Up to 96 hours post-doseenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Plasma renin activity (PRA)Change from baseline in plasma renin activitydate_rangeTime Frame:Prior to dosing and 12 hours post-doseenhanced_encryptionNoSafety Issue:
- Plasma angiotensin IIChange from baseline in plasma angiotensin IIdate_rangeTime Frame:Prior to dosing and 12 hours post-doseenhanced_encryptionNoSafety Issue:
- Serum aldosteroneChange from baseline in serum aldosteronedate_rangeTime Frame:Prior to dosing and 12 hours post-doseenhanced_encryptionNoSafety Issue:
- Plasminogen activator inhibitor-1 (PAI-1)Change from baseline in PAI-1date_rangeTime Frame:Prior to dosing and 12 hours post-doseenhanced_encryptionNoSafety Issue:
- Urinary volumeChange in volume of urine excreteddate_rangeTime Frame:Prior to dosing up to 24 hours post-doseenhanced_encryptionNoSafety Issue:
- Urinary creatinineChange in urine creatinine concentrationsdate_rangeTime Frame:Prior to dosing up to 24 hours post-doseenhanced_encryptionNoSafety Issue:
- Urinary electrolytesChange in urinary electrolytesdate_rangeTime Frame:Prior to dosing up to 24 hours post-doseenhanced_encryptionNoSafety Issue:
- Half-life associated with the terminal slope (t½)t½ for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)date_rangeTime Frame:Up to 96 hours post-doseenhanced_encryptionNoSafety Issue:
- Fraction unbound (fu)fu for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)date_rangeTime Frame:1 hour and 6 hours post-doseenhanced_encryptionNoSafety Issue:
- AUC divided by dose (AUC/D)AUC/D for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)date_rangeTime Frame:Up to 96 hours post-doseenhanced_encryptionNoSafety Issue:
- 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)date_rangeTime Frame:Up to 96 hours post-doseenhanced_encryptionNoSafety Issue:
- Cmax divided by dose (Cmax/D)Cmax/D for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)date_rangeTime Frame:Up to 96 hours post-doseenhanced_encryptionNoSafety Issue:
- 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)date_rangeTime Frame:Up to 96 hours post-doseenhanced_encryptionNoSafety Issue:
- Mean residence time (MRT)MRT for BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)date_rangeTime Frame:Up to 96 hours post-doseenhanced_encryptionNoSafety Issue:
- 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)date_rangeTime Frame:Up to 96 hours post-doseenhanced_encryptionNoSafety Issue:
- 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)date_rangeTime Frame:Up to 96 hours post-doseenhanced_encryptionNoSafety Issue:
- 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)date_rangeTime Frame:Up to 96 hours post-doseenhanced_encryptionNoSafety Issue:
- 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)date_rangeTime Frame:Up to 96 hours post-doseenhanced_encryptionNoSafety Issue:
- 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)date_rangeTime Frame:Up to 96 hours post-doseenhanced_encryptionNoSafety Issue:
- Renal body clearance of drug (CLR)CLR of BAY94-8862 and its metabolites M1 (BAY1040818), M2 (BAY1088089) and M3 (BAY1088090)date_rangeTime Frame:Up to 96 hours post-doseenhanced_encryptionNoSafety Issue:
- Number of participants with adverse eventsdate_rangeTime Frame:Approximately 5 weeksenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
Basic ScienceAllocation
Non-randomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
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