check_circleStudy Completed

Anemia

Bayer Identifier:

14627

ClinicalTrials.gov Identifier:

NCT01332942

EudraCT Number:

2010-023585-50

EU CT Number:

Not Available
Combined single / multiple dose escalation study in patients with renal anemia due to CKD (chronic kidney disease)

Trial purpose

The drug that is under investigation during this study is BAY85-3934 which is intended to be used as a treatment for patients suffering from renal anemia due to chronic kidney disease (stage 3 and 4).
The purpose of this study is to provide safety and tolerability information on the drug. Other objectives of the study are to investigate the effect of the drug on the body (pharmacodynamics) as well as the absorption, breakdown, metabolism, distribution and excretion (pharmacokinetics) by measuring the concentration in blood and urine.
The study will be conducted in one study center in the United Kingdom and several centers in Germany. 84 (of which 36 are optional) patients who meet the inclusion criteria will participate in the study. BAY 85-3934 will be given following a combined single / multiple dose escalation design in seven (of which three are optional) dose steps.

Key Participants Requirements

Sex

Both

Age

18 - 85 Years
  • The informed consent must be signed before any study specific tests or procedures are done
    - Renal anemia due to CKD (stage 3 and 4) not on dialysis assessed by medical history and Creatine Clearance (CLCR) between 15 to 59 mL/min ± 10 % (ie CLCR between 13 – 65 mL/min) estimated at the pre-study visit from the creatinine concentration measured in serum (Modification of Diet in Renal Disease (MDRD) formula)
    - Stable renal disease, ie without major changes in therapy within the last 6 weeks and not expected to begin dialysis within the study.
    - Female subjects with no child-bearing potential (postmenopausal women with 12 month of spontaneous amenorrhea or with 6 month of spontaneous amenorrhea and serum FSH levels > 30 mIU/mL, women with 6 weeks post bilateral ovariectomy, woman with bilateral tubal ligation, and women with hysterectomy).
    - Male subjects who agree to use two forms of effective contraception during the study and for 12 weeks after receiving the study drug. This must include a condom with spermicide gel for 21 days after drug administration.
    - Male subjects who agree not to act as sperm donors for 12 weeks after dosing.
    - Age: ≥ 18 and ≤ 85 years at the pre-study visit
    - Body mass index (BMI): ≥ 18 and ≤ 35 kg / m2 at the pre-study visit
    - Hemoglobin (Hb) of 8.0 – 12 g/dL (male) or 8.0 – 11.5 g/dL (female) at two consecutive measurements (1 measurement performed within 12 weeks to 2 days before the pre-study visit during routine diagnostics independently of the study and 1 measurement at the pre-study visit)
    - Ability to understand and follow study-related instructions
  • - Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal

    - Known hypersensitivity to the study drugs (active substances or excipients of the preparations)

    - Known severe allergies, non-allergic drug reactions, or multiple drug allergies
    - Patients with impaired liver function (Child Pugh B and C based on medical history)
    - Patients with hemolysis/hemolytic anemia or active bleeding/blood loss
    - Major surgery or an intervention causing relevant blood loss or inflammation within the last 2 month
    - Planned intervention or surgery during the study which might impact the study objectives.
    - Febrile illness within 1 week before the first study drug administration or clinically significant infection.
    - Patients with chronic inflammatory diseases (eg systemic lupus erythematosis, rheumatoid arthritis, Crohn´s disease) that could impact erythropoiesis or with persistent inflammatory activity (eg C-reactive protein (CRP) > 20mg/L)
    - History of thrombotic or thromboembolic events (e.g. 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.
    - History of myelodysplastic syndrome, multiple myeloma, bone marrow fibrosis, or pure red cell aplasia.
    - History of hemosiderosis or hemochromatosis.
    - Patients with a history of malignant disease during the last 5 years
    - Treatment with erythropoiesis stimulating agents (ESA) within the last 4 weeks before first intake of study drug
    - Intravenous iron substitution 2 weeks before and during the treatment period with BAY 85-3934
    - RBC transfusion during previous 8 weeks
    - Use of products containing carnitine and/or anabolics
    - Use of medicines or substances which oppose the study objectives or which might influence them within 14 days before the first study drug administration
    - Significant uncorrected rhythm or conduction disturbances such as a second- or third-degree AV block without a cardiac pacemaker or episodes of sustained ventricular tachycardia
    - Systolic blood pressure below 100 or above 160 mmHg at the pre-study visit
    - Diastolic blood pressure below 50 or above 100 mmHg at the pre-study visit
    - 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
    - Heart rate above 110 bpm
    - Ferritin levels ≤ 30 ng/mL at the pre-study visit
    - Transferrin-saturation < 15% at the pre-study visit

Trial summary

Enrollment Goal
44
Trial Dates
April 2011 - December 2013
Phase
Phase 1
Could I Receive a placebo
No
Products
Molidustat (BAY85-3934)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
London, SE5 9RS, United Kingdom
Completed
Kiel, 24105, Germany
Completed
Köln, 50931, Germany
Completed
Wuppertal, 42283, Germany
Completed
München, 81241, Germany
Completed
Berlin, 13125, Germany
Completed
Hamburg, 20253, Germany
Completed
Hannover, 30159, Germany
Withdrawn
Hannover, 30625, Germany
Withdrawn
Berlin, 10117, Germany

Primary Outcome

  • Number of Subjects with Treatment-Emergent Adverse Events (TEAE)
    An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important serious event. TEAEs were defined as AEs/SAEs that started or worsened after the study drug treatment.
    date_rangeTime Frame:
    From start of study drug administration until last follow-up visit (14 days after the last study drug administration)
    enhanced_encryption
    Safety Issue:
    Yes
  • Mean Change in Heart Rate Within 4 hours Post-dose
    Heart rate was observed in all treatment groups in supine position.
    date_rangeTime Frame:
    Within 4 hours from after administration of study drug on Day 1 and Day 14
    enhanced_encryption
    Safety Issue:
    No
  • Mean Change in Heart Rate Over 1 Minute for Doses 25, 50, 75 Milligrams
    Heart rate was assessed over 1 minute from the Electrocardiogram (ECG) recording.
    date_rangeTime Frame:
    From start of study drug administration until 12 hours after the last study drug administration
    enhanced_encryption
    Safety Issue:
    No
  • Mean Change in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Within 4 hours Post-dose
    SBP, DBP was observed in all treatment groups in supine phase.
    date_rangeTime Frame:
    Within 4 hours post-dose at Day 1 and Day 14
    enhanced_encryption
    Safety Issue:
    No
  • Number of Subjects with Clinically Relevant Abnormal Findings in the Electrocardiogram (ECG)
    Electrocardiograms were recorded and analyzed by an electronic ECG reading system.
    date_rangeTime Frame:
    Day 1 and Day 14
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of Subjects with Clinically Relevant Laboratory Values
    Laboratory parameters include hematology, coagulation, serum chemistry, urinalysis.
    date_rangeTime Frame:
    Day 1 and Day 14
    enhanced_encryption
    Safety Issue:
    Yes
  • Maximum Observed Drug Concentration (Cmax) in Plasma of Molidustat and its Metabolite After Single Dose of Molidustat
    Cmax refers to the highest measured drug concentration after a single dose which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    date_rangeTime Frame:
    Single dose: 0-48 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Maximum Observed Drug Concentration Divided by Dose (Cmax/D) in Plasma of Molidustat and its Metabolite After Single Dose of Molidustat
    Cmax/D is defined as maximum observed drug concentration divided by dose. Cmax refers to the highest measured drug concentration after single dose which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    date_rangeTime Frame:
    Single dose: 0-48 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) in Plasma of Molidustat and its Metabolite After Single Dose of Molidustat
    AUC is a measure of systemic drug exposure after single dose, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC is defined as area under concentration versus time curve from time 0 (pre-dose) to extrapolated infinite time. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    date_rangeTime Frame:
    Single dose: 0-48 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Area Under the Concentration Versus Time Curve From Zero to Infinity Divided by Dose (AUC/D) in Plasma of Molidustat and its Metabolite After Single Dose of Molidustat
    AUC is a measure of systemic drug exposure after single dose, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC is defined as area under concentration versus time curve from time 0 (pre-dose) to extrapolated infinite time. AUC/D is defined as area under the concentration versus time curve from zero to infinity divided by dose. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    date_rangeTime Frame:
    Single dose: 0-48 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Maximum Observed Drug Concentration (Cmax,md) in Plasma of Molidustat and its Metabolite After Multiple Dose Administration of Molidustat
    Cmax,md defined as maximum observed drug concentration after multiple dose. Cmax,md refers to the highest measured drug concentration in the dosing interval which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    date_rangeTime Frame:
    Multiple dose: 0-24 hours post dose on Day 14 (13d)
    enhanced_encryption
    Safety Issue:
    No
  • Maximum Observed Drug Concentration in Plasma Divided by Dose (Cmax,md/D) of Molidustat and its Metabolite After Multiple Dose Administration of Molidustat
    Cmax,md/D is defined as maximum observed drug concentration divided by dose after multiple dose administration. Cmax,md refers to the highest measured drug concentration within the dosing interval which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    date_rangeTime Frame:
    Multiple dose: 0-24 hours post dose on Day 14 (13d)
    enhanced_encryption
    Safety Issue:
    No
  • Area Under the Concentration Versus Time Curve From 0 to 24 hour (AUC[0-24]md) in Plasma During any Dose Interval of Molidustat and its Metabolite After Multiple Dose of Molidustat
    AUC(0-24)md is defined as area under the concentration versus time curve from 0 to 24 hour after multiple dose. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    date_rangeTime Frame:
    Multiple dose: 0-24 hours post dose on Day 14 (13d)
    enhanced_encryption
    Safety Issue:
    No
  • Area Under the Concentration Versus Time Curve From 0 to 24 hour Divided by Dose (AUC[0-24] md/D) in Plasma During any Dose Interval of Molidustat and its Metabolite After Multiple Dose of Molidustat
    AUC(0-24)md/D is defined as area under the concentration versus time curve from 0 to 24 hour divided by dose after multiple dose. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    date_rangeTime Frame:
    Multiple dose: 0-24 hours post dose on Day 14 (13d)
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Maximum Observed Drug Concentration in Plasma Divided by Dose per Kilogram Body Weight (Cmax,norm) of Molidustat and its Metabolite After Single Dose of Molidustat
    Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. Cmax,norm is defined as maximum observed drug concentration divided by dose per kilogram body weight. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    date_rangeTime Frame:
    Single dose: 0-48 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Area Under the Concentration Versus Time Curve From Zero to Infinity in Plasma Divided by Dose per Kilogram Body Weight (AUCnorm) of Molidustat and its Metabolite After Single Dose of Molidustat
    AUC is a measure of systemic drug exposure after single dose, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUCnorm is defined as area under the concentration versus time curve from zero to infinity divided by dose per kilogram body weight. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    date_rangeTime Frame:
    Single dose: 0-48 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Area Under the Concentration Versus Time Curve From Zero to 24 hour (AUC[0-24]) in Plasma of Molidustat and its Metabolite After Single Dose of Molidustat
    AUC(0-24) is defined as area under the concentration versus time curve from zero to 24 hours after a single dose. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    date_rangeTime Frame:
    Single dose: 0-24 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Area Under the Concentration Versus Time Curve From Zero to the Last Data Point Above the Lower Limit of Quantification (AUC[0-tlast]) in Plasma of Molidustat and its Metabolite After Single Dose of Molidustat
    AUC is a measure of systemic drug exposure after single dose, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC(0-tlast) is defined as AUC from time zero to the last data point above the lower limit of quantification. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    date_rangeTime Frame:
    Single dose: 0-48 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Half Life Associated With the Terminal Slope (t1/2) in Plasma of Molidustat and its Metabolite After Single Dose of Molidustat
    Half life associated with terminal slope. It is the time taken for the blood plasma concentration to reach half the concentration in the terminal phase. It is expressed in hours and derived from the terminal slope of the concentration versus time curve. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    date_rangeTime Frame:
    Single dose: 0-48 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Time to Reach Maximum Drug Concentration (tmax) in Plasma of Molidustat and its Metabolite After Single Dose of Molidustat
    tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content. Median and range were reported.
    date_rangeTime Frame:
    Single dose: 0-48 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Mean Residence Time (MRT) of Molidustat and its Metabolite After Single Dose of Molidustat
    MRT is an average duration of the drug in the body, and is expressed in hours. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    date_rangeTime Frame:
    Single dose: 0-48 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Apparent Oral Clearance (CL/F) of Molidustat and its Metabolite After Single Dose of Molidustat
    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    date_rangeTime Frame:
    Single dose: 0-48 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Apparent Volume of Distribution During Terminal Phase (Vz/F) After Single Dose of Molidustat
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the observed plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    date_rangeTime Frame:
    Single dose: 0-48 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Amount Excreted into Urine (Aeur) of Molidustat and its Metabolite After Single Dose of Molidustat
    Aeur refers to the amount of molidustat excreted in urine.
    date_rangeTime Frame:
    Urine collection intervals: 0d00 - 0d12h, 0d12h - 1d00
    enhanced_encryption
    Safety Issue:
    No
  • Renal Body Clearance of Drug (CLR) of Molidustat and its Metabolite After Single Dose of Molidustat
    Renal clearance describes the removal of drug from a volume of plasma in a given unit of time by the kidneys. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    date_rangeTime Frame:
    Urine collection interval: 0d00 - 1d00
    enhanced_encryption
    Safety Issue:
    No
  • Maximum Observed Concentration Divided by Dose per Kilogram Body Weight (Cmax,md,norm) in Plasma After Multiple Dose Administration During a Dosage Interval
    Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. Cmax,md,norm is defined as maximum observed concentration during a given dosing interval divided by dose per kilogram body weight in plasma after multiple dose administration. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    date_rangeTime Frame:
    Multiple dose: 0-24 hours post dose on Day 14 (13d)
    enhanced_encryption
    Safety Issue:
    No
  • Area Under the Concentration Versus Time Curve From 0 to 24 hour Divided by Dose per Kilogram Body Weight (AUC[0-24]md,norm) in Plasma After Multiple Dose Administration During a Dosage Interval
    AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC(0-24) md,norm is defined as area under the concentration versus time curve from 0 to 24 hour divided by dose per kilogram body weight after multiple dose administration. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    date_rangeTime Frame:
    Multiple dose: 0-24 hours post dose on Day 14 (13d)
    enhanced_encryption
    Safety Issue:
    No
  • Half Life Associated With the Terminal Slope (t1/2,md) in Plasma of Molidustat and its Metabolite After Multiple Dose of Molidustat
    Half life associated with terminal slope. It is the time taken for the blood plasma concentration to reach half the concentration in the terminal phase. It is expressed in hours and derived from the terminal slope of the concentration versus time curve. t1/2,md is defined as half life associated with the terminal slope after multiple dose. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    date_rangeTime Frame:
    Multiple dose: 0-24 hours post dose on Day 14 (13d)
    enhanced_encryption
    Safety Issue:
    No
  • Time to Reach Maximum Drug Concentration (tmax,md) in Plasma of Molidustat and its Metabolite After Multiple Dose of Molidustat
    tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content. tmax,md is defined as time to reach maximum drug concentration after multiple dose. Median and range were reported.
    date_rangeTime Frame:
    Multiple dose: 0-24 hours post dose on Day 14 (13d)
    enhanced_encryption
    Safety Issue:
    No
  • Amount Excreted into Urine (Aeur,md)of Molidustat and its Metabolite After Multiple Dose of Molidustat
    Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    date_rangeTime Frame:
    Urine collection interval: 13d00 - 14d00
    enhanced_encryption
    Safety Issue:
    No
  • Renal Body Clearance (CLR,md) of Molidustat and its Metabolite After Multiple Dose of Molidustat
    Renal clearance describes the removal of drug from a volume of plasma in a given unit of time by the kidneys. CLR,md is defined as renal body clearance of drug after multiple dose. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    date_rangeTime Frame:
    Urine collection interval: 13d00 - 14d00
    enhanced_encryption
    Safety Issue:
    No
  • Accumulation Ratio of AUC in the Dosing Interval (RAAUC) of Molidustat
    RAAUC was calculated by using formula AUC(0-24)[13day] / AUC(0-24)[0day].
    date_rangeTime Frame:
    All samples from 0-24h on 0d and from 0-24h on 13d
    enhanced_encryption
    Safety Issue:
    No
  • Accumulation Ratio of Cmax (RACmax) of Molidustat
    RACmax was calculated by using formula Cmax[13day] / Cmax[0day].
    date_rangeTime Frame:
    All samples from 0-24h on 0d and from 0-24h on 13d
    enhanced_encryption
    Safety Issue:
    No
  • Linearity Factor of Pharmacokinetics After Repeated Administration of Identical Doses (RLin) of Molidustat
    RLin was calculated by using formula AUC(0-24)[13day] / AUC[0day].
    date_rangeTime Frame:
    All samples from 0-24h on 0d and from 0-24h on 13d
    enhanced_encryption
    Safety Issue:
    No
  • Erythropoietin Concentration: Area Under the Concentration Versus Time Curve From 0 to 24 hour (AUC[0-24]) Post-dose on Day 1 (0d)
    AUC(0-24) is defined as area under the concentration versus time curve from zero to 24 hours after a single dose. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    date_rangeTime Frame:
    Single dose: Pre-dose and 4, 8, 12 and 24 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Erythropoietin Concentration: Area Under the Concentration Versus Time Curve From 0 to 24 hour (AUC[0-24]md) in Plasma After Multiple Dose on Day 14 (13d)
    Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    date_rangeTime Frame:
    Multiple dose: Pre-dose and 4, 8, 12 and 24 hours post-dose on 13day
    enhanced_encryption
    Safety Issue:
    No
  • Erythropoietin Concentration: Maximum Observed Drug Concentration in Plasma (Cmax[0-24]) After Single Dose of Molidustat on Day 1 (0d)
    Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    date_rangeTime Frame:
    Single dose: Pre-dose and 4, 8, 12, 24 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • Erythropoietin Concentration: Maximum Observed Drug Concentration in Plasma (Cmax [0-24]md) Within 0-24 hours Post Dose on Day 14 (13d)
    Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    date_rangeTime Frame:
    Multiple dose: Pre-dose and 4, 8, 12 and 24 hours post-dose on 13day
    enhanced_encryption
    Safety Issue:
    No
  • Pharmacodynamic Parameter: Maximum Observed Drug Concentration in Plasma (Cmax) of Reticulocytes (Absolute) Within Day 1 (0d) - Day 14 (13d)
    date_rangeTime Frame:
    Day 1 to Day 14
    enhanced_encryption
    Safety Issue:
    No
  • Pharmacodynamic Parameter: Maximum Observed Drug Concentration in Plasma (Cmax) of Reticulocytes ( Ratio-to-Baseline-Adjusted) Within Day 1(0d) - Day 14 (13d)
    date_rangeTime Frame:
    Day 1 to Day 14
    enhanced_encryption
    Safety Issue:
    No
  • Pharmacodynamic Parameter: Maximum Observed Drug Concentration in Plasma (Cmax) of Hemoglobin (Absolute) Within Day 1 (0d) - Day 14 (13d)
    date_rangeTime Frame:
    Day 1 to Day 14
    enhanced_encryption
    Safety Issue:
    No
  • Pharmacodynamic Parameter: Maximum Observed Drug Concentration in Plasma (Cmax) of Hemoglobin ( Ratio-to-Baseline-Adjusted) Within Day 1 (0d) - Day
    date_rangeTime Frame:
    Day 1 to Day 14
    enhanced_encryption
    Safety Issue:
    No
  • Pharmacodynamic Parameter: Maximum Observed Drug Concentration in Plasma (Cmax) of Hematocrit (Absolute) Within Day 1 (0d) - Day 14(13d)
    date_rangeTime Frame:
    Day 1 to Day 14
    enhanced_encryption
    Safety Issue:
    No
  • Pharmacodynamic Parameter: Maximum Observed Drug Concentration in Plasma (Cmax) of Hematocrit (Ratio-to-Baseline-Adjusted) Within Day 1( 0d) - Day 14 (13d)
    date_rangeTime Frame:
    Day 1 to Day 14
    enhanced_encryption
    Safety Issue:
    No

Trial design

Randomized, single-blind, placebo-controlled, combined single / multiple dose escalation, group comparison study to investigate safety, tolerability, pharmacodynamic effect and pharmacokinetics of BAY 85-3934 in patients with renal anemia due to CKD (stages 3 and 4)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
Single Blind
Assignment
Parallel Assignment
Trial Arms
6

Additional Information

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