Trial Condition(s):

Kidney Diseases

Dose escalation study to investigate safety, tolerability, pharmacodynamics, and pharmacokinetics of BAY85-3934 in subjects with chronic kidney disease (CKD)

Bayer Identifier:

16370

ClinicalTrials.gov Identifier:

NCT01679587

EudraCT Number:

2012-002375-33

Study Completed

Trial Purpose

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

Inclusion Criteria
- 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
Exclusion Criteria
- 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

Trial Summary

Enrollment Goal
49
Trial Dates
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Phase
1
Could I receive a placebo?
Yes
Products
Molidustat (BAY85-3934)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Kiel, Germany, 24105

Status
Completed
 
Locations

Investigative Site

Mönchengladbach, Germany, 41061

Status
Completed
 
Locations

Investigative Site

München, Germany, 81241

Status
Completed
 

Trial Design