check_circleStudy Completed
Kidney Diseases
Bayer Identifier:
16370
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Dose escalation study to investigate safety, tolerability, pharmacodynamics, and pharmacokinetics of BAY85-3934 in subjects with chronic kidney disease (CKD)
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
Key Participants Requirements
Sex
BothAge
18 - 79 YearsTrial summary
Enrollment Goal
49Trial Dates
September 2012 - July 2013Phase
Phase 1Could I Receive a placebo
YesProducts
Molidustat (BAY85-3934)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Kiel, 24105, Germany | |
Completed | Mönchengladbach, 41061, Germany | |
Completed | München, 81241, Germany |
Primary Outcome
- Number of participants with adverse eventsdate_rangeTime Frame:Approximately 9 weeksenhanced_encryptionYesSafety Issue:
- Blood pressureSystolic, diastolic, mean blood pressuredate_rangeTime Frame:Approximately 9 weeksenhanced_encryptionYesSafety Issue:
- Heart ratedate_rangeTime Frame:Approximately 9 weeksenhanced_encryptionYesSafety Issue:
- CmaxMaximum observed drug concentration in measured matrix after single dose administrationdate_rangeTime Frame:Pre-dose and up to 48 h post-doseenhanced_encryptionNoSafety Issue:
- Cmax/DCmax divided by dosedate_rangeTime Frame:Pre-dose and up to 48 h post-doseenhanced_encryptionNoSafety Issue:
- AUCArea under the concentration vs time curve from zero to infinity after single dosedate_rangeTime Frame:Pre-dose and up to 48 h post-doseenhanced_encryptionNoSafety Issue:
- AUC/DAUC divided by dosedate_rangeTime Frame:Pre-dose and up to 48 h post-doseenhanced_encryptionNoSafety Issue:
- Heart rate over 1 mindate_rangeTime Frame:Pre-dose and up to 24 h post-doseenhanced_encryptionNoSafety Issue:
- Standing blood pressure proceduredate_rangeTime Frame:Starting from 2 h post-dose and up to 4 h post-doseenhanced_encryptionNoSafety Issue:
- Impedance cardiographyStroke volume, heart rate, cardiac index, cardiac output, and total peripheral resistancedate_rangeTime Frame:Pre-dose and up tp 8 h post-doseenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Change of hematology profileHematology profile includes blood concentration of erythropoietin, reticulocytes, erythrocytes, hemoglobin, hematocrit, and exploratory biomarkers.date_rangeTime Frame:From baseline to Day 1 after single doseenhanced_encryptionNoSafety Issue:
- Cmax,normCmax divided by dose per body weightdate_rangeTime Frame:Pre-dose and up to 48 h post-doseenhanced_encryptionNoSafety Issue:
- AUCnormAUC divided by dose per body weightdate_rangeTime Frame:Pre-dose and up to 48 h post-doseenhanced_encryptionNoSafety Issue:
- AUC(0-24)AUC from 0 until 24 h after study drug administrationdate_rangeTime Frame:Pre-dose and up to 24 h post-doseenhanced_encryptionNoSafety Issue:
- AUC(0-tlast)AUC from time 0 to the last data point > lower limit of quantificationdate_rangeTime Frame:Pre-dose and up to 48 h post-doseenhanced_encryptionNoSafety Issue:
- t½Half-life associated with the terminal slopedate_rangeTime Frame:Pre-dose and up to 48 h post-doseenhanced_encryptionNoSafety Issue:
- tmaxTime to reach Cmax (in case of two identical Cmax values, the first tmax was used)date_rangeTime Frame:Pre-dose and up to 48 h post-doseenhanced_encryptionNoSafety Issue:
- MRTMean residence timedate_rangeTime Frame:Pre-dose and up to 48 h post-doseenhanced_encryptionNoSafety Issue:
- CL/FTotal body clearance of drug calculated after extravascular administration (eg, apparent oral clearance)date_rangeTime Frame:Pre-dose and up to 48 h post-doseenhanced_encryptionNoSafety Issue:
- Vz/FApparent volume of distribution during terminal phase after extravascular administrationdate_rangeTime Frame:Pre-dose and up to 48 h post-doseenhanced_encryptionNoSafety Issue:
- Geometric mean erythropoietin Cmaxdate_rangeTime Frame:Pre-dose and up to 24 h post-doseenhanced_encryptionYesSafety Issue:
- Geometric mean reticulocyte countdate_rangeTime Frame:Pre-dose and up to 24 h post-doseenhanced_encryptionYesSafety Issue:
- Geometric mean erythrocyte countdate_rangeTime Frame:Pre-dose and up to 24 h post-doseenhanced_encryptionYesSafety Issue:
- Geometric mean reticulocytes/erythrocytes valuesdate_rangeTime Frame:Pre-dose and up to 24 h post-doseenhanced_encryptionYesSafety Issue:
- Geometric mean hemoglobin valuesdate_rangeTime Frame:Pre-dose and up to 24 h post-doseenhanced_encryptionYesSafety Issue:
- Geometric mean hematocritdate_rangeTime Frame:Pre-dose and up to 24 h post-doseenhanced_encryptionYesSafety Issue:
- Geometric mean erythropoietin tmaxdate_rangeTime Frame:Pre-dose and up to 24 h post-doseenhanced_encryptionNoSafety Issue:
- Geometric mean erythropoietin AUC(0-24)date_rangeTime Frame:Pre-dose and up to 24 h post-doseenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
Single BlindAssignment
Crossover AssignmentTrial Arms
4Additional Information
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