Trial Condition(s):
Dose escalation study to investigate safety, tolerability, pharmacodynamics, and pharmacokinetics of BAY85-3934 in subjects with chronic kidney disease (CKD)
16370
Not Available
Primary objective was to assess in subjects with CKD: Safety and tolerability of molidustat (BAY 85-3934), effects of molidustat on non-invasive hemodynamics Secondary objectives were to assess: Effects on pharmacodynamic parameters of erythropoiesis (erythropoietin, reticulocytes, erythrocytes, hemoglobin, hematocrit), pharmacokinetics of molidustat, exploratory biomarkers, ie, midregional pro-atrial natriuretic peptide, midregional pro-adrenomedullin, plasma renin activity, and optionally B-type natriuretic peptide, vascular endothelial growth factor, cyclic guanosine monophosphate, cyclic adenosine monophosphate, and noradrenaline
- Presence of chronic kidney disease (CKD) not on dialysis assessed by medical history and eGFR (MDRD) = < 60 mL/min estimated at the pre-study visit - Stable renal disease, ie not expected to begin dialysis during the study - Systolic blood pressure =>110 mmHg and =<160 mmHg - Heart rate =<100 BPM - Hemoglobin = >9 g/dL - Female subjects without child-bearing potential, ie postmenopausal women with 12 months of spontaneous amenorrhea or with 6 months of spontaneous amenorrhea and serum FSH levels >30 mIU/mL, women with 6 weeks post bilateral ovariectomy, women with bilateral tubal ligation, and women with hysterectomy - Body mass index (BMI): = >18 and = < 35 kg/m2 at the pre-study visit
- Incompletely cured pre-existing diseases for which a relevant impairment of absorption, distribution, metabolism, elimination or effects of the study drug is assumed - Known hypersensitivity to the study drugs (active substances or excipients of the preparations) - Known severe allergies, non-allergic drug reactions, or multiple drug allergies - Chronic heart failure, New York Heart Association (NYHA) III-IV - Coronary artery disease with uncured significant stenosis - Angina pectoris - Significant stenosis of cerebral vessels - Significant uncorrected rhythm or conduction disturbances such as a second- or third-degree atrioventricular block without a cardiac pacemaker or episodes of sustained ventricular tachycardia - Subjects with impaired liver function (Child Pugh B to C based on medical history) - History of thrombotic or thromboembolic events (eg myocardial infarction, stroke, transient ischemic attack, deep vein thrombosis, pulmonary embolism) within the recent 6 months - Proliferative choroidal or retinal disease, such as neovascular age-related macular degeneration or proliferative diabetic retinopathy that required or is likely to require treatment (intraocular injections or laser photocoagulation) during the study - Subjects with a history of malignant disease during the last 5 years - Treatment with EPO-stimulating agents (ESA) or rhEPO within the last 2 weeks before first intake of study drug - Suspicion of drug or alcohol abuse - Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV 1+2) at the pre-study visit
Locations | Status | |
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Locations Investigative Site Kiel, Germany, 24105 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mönchengladbach, Germany, 41061 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site München, Germany, 81241 | Status Completed | Contact Us: E-mail: [email protected]hcare.com Phone: Not Available |
Multicenter, randomized, single-blind, placebo-controlled, combined 2-fold cross-over and group-comparison, dose-escalation study to investigate safety, tolerability, pharmacodynamics, and pharmacokinetics of single oral doses of BAY 85-3934 in subjects with chronic kidney disease (CKD)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
Single Blind
Assignment:
Crossover Assignment
Trial Arms:
4