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

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Bayer

Status and phase

Completed
Phase 1

Conditions

Kidney Diseases

Treatments

Drug: Placebo
Drug: Molidustat (BAY85-3934)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01679587
2012-002375-33 (EudraCT Number)
16370

Details and patient eligibility

About

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

Enrollment

49 patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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 design

49 participants in 4 patient groups

Molidustat, 80 mg
Experimental group
Description:
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.
Treatment:
Drug: Placebo
Drug: Molidustat (BAY85-3934)
Molidustat, 120 mg
Experimental group
Description:
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.
Treatment:
Drug: Placebo
Drug: Molidustat (BAY85-3934)
Molidustat, 40 mg
Experimental group
Description:
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.
Treatment:
Drug: Placebo
Drug: Molidustat (BAY85-3934)
Molidustat, 160 mg
Experimental group
Description:
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.
Treatment:
Drug: Placebo
Drug: Molidustat (BAY85-3934)

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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