Dose Escalation Study to Investigate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BAY85-3934 in Subjects With Chronic Kidney Disease (CKD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-07-31

Brief Summary

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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

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Detailed Description

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Conditions

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Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Participants

Study Groups

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Molidustat, 80 mg

Subjects received a single oral dose of 80 mg BAY 85-3934 in the first period and placebo in the second period, separated by a wash-out period of at least 1 week.

Group Type EXPERIMENTAL

Molidustat (BAY85-3934)

Intervention Type DRUG

20 mg molidustat as a single tablet

Placebo

Intervention Type DRUG

Single oral dose of matching placebo will be given in each treatment arm

Molidustat, 120 mg

Subjects received a single oral dose of 120 mg BAY 85-3934 in the first period and placebo in the second period, separated by a wash-out period of at least 1 week.

Group Type EXPERIMENTAL

Molidustat (BAY85-3934)

Intervention Type DRUG

20 mg molidustat as a single tablet

Placebo

Intervention Type DRUG

Single oral dose of matching placebo will be given in each treatment arm

Molidustat, 40 mg

Subjects received a single oral dose of 40 mg BAY 85-3934 in the first period and placebo in the second period, separated by a wash-out period of at least 1 week. This is an optional dose escalation step.

Group Type EXPERIMENTAL

Molidustat (BAY85-3934)

Intervention Type DRUG

20 mg molidustat as a single tablet

Placebo

Intervention Type DRUG

Single oral dose of matching placebo will be given in each treatment arm

Molidustat, 160 mg

Subjects received a single oral dose of 160 mg BAY 85-3934 in the first period and placebo in the second period, separated by a wash-out period of at least 1 week. This is an optional dose escalation step.

Group Type EXPERIMENTAL

Molidustat (BAY85-3934)

Intervention Type DRUG

20 mg molidustat as a single tablet

Placebo

Intervention Type DRUG

Single oral dose of matching placebo will be given in each treatment arm

Interventions

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Molidustat (BAY85-3934)

20 mg molidustat as a single tablet

Intervention Type DRUG

Placebo

Single oral dose of matching placebo will be given in each treatment arm

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No