Clareo Health | Dose Escalation Study to Investigate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BAY85-3934 in Subjects With Chronic Kidney Disease (CKD)
Dose Escalation Study to Investigate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BAY85-3934 in Subjects With Chronic Kidney Disease (CKD)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–79
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
