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CompletedNCT01679587Updated May 2, 2016

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

A Phase 1 interventional study of Molidustat (BAY85-3934) and Placebo in Kidney Diseases, sponsored by Bayer. Completed at 3 sites in Germany. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2016-05-02.

Sponsored by Bayer · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
18 Years to 79 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Kidney Diseases

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03

In context

Kidney Diseases

3,843 studies on the registry are indexed under Kidney Diseases; 492 are open to participants now.

This study's enrollment of 49 is below the median of 70 across 2,645 interventional studies indexed under Kidney Diseases.

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Lead sponsor

Bayer is the lead sponsor of 1,674 studies on the registry; 54 are open to participants now.

Of its 213 completed or terminated interventional studies of FDA-regulated products, 130 (61%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    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.

    Drug: Molidustat (BAY85-3934) · Drug: Placebo

  • Experimental
    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.

    Drug: Molidustat (BAY85-3934) · Drug: Placebo

  • Experimental
    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.

    Drug: Molidustat (BAY85-3934) · Drug: Placebo

  • Experimental
    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.

    Drug: Molidustat (BAY85-3934) · Drug: Placebo

Interventions

  • DrugMolidustat (BAY85-3934)

    20 mg molidustat as a single tablet

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. Number of participants with adverse events

    Time frame: Approximately 9 weeks

  2. Blood pressure

    Systolic, diastolic, mean blood pressure

    Time frame: Approximately 9 weeks

  3. Heart rate

    Time frame: Approximately 9 weeks

  4. Cmax

    Maximum observed drug concentration in measured matrix after single dose administration

    Time frame: Pre-dose and up to 48 h post-dose

  5. Cmax/D

    Cmax divided by dose

    Time frame: Pre-dose and up to 48 h post-dose

  6. AUC

    Area under the concentration vs time curve from zero to infinity after single dose

    Time frame: Pre-dose and up to 48 h post-dose

  7. AUC/D

    AUC divided by dose

    Time frame: Pre-dose and up to 48 h post-dose

  8. Heart rate over 1 min

    Time frame: Pre-dose and up to 24 h post-dose

  9. Standing blood pressure procedure

    Time frame: Starting from 2 h post-dose and up to 4 h post-dose

  10. Impedance cardiography

    Stroke volume, heart rate, cardiac index, cardiac output, and total peripheral resistance

    Time frame: Pre-dose and up tp 8 h post-dose

Secondary outcomes

  1. Change of hematology profile

    Hematology profile includes blood concentration of erythropoietin, reticulocytes, erythrocytes, hemoglobin, hematocrit, and exploratory biomarkers.

    Time frame: From baseline to Day 1 after single dose

  2. Cmax,norm

    Cmax divided by dose per body weight

    Time frame: Pre-dose and up to 48 h post-dose

  3. AUCnorm

    AUC divided by dose per body weight

    Time frame: Pre-dose and up to 48 h post-dose

  4. AUC(0-24)

    AUC from 0 until 24 h after study drug administration

    Time frame: Pre-dose and up to 24 h post-dose

  5. AUC(0-tlast)

    AUC from time 0 to the last data point \> lower limit of quantification

    Time frame: Pre-dose and up to 48 h post-dose

  6. t½

    Half-life associated with the terminal slope

    Time frame: Pre-dose and up to 48 h post-dose

  7. tmax

    Time to reach Cmax (in case of two identical Cmax values, the first tmax was used)

    Time frame: Pre-dose and up to 48 h post-dose

  8. MRT

    Mean residence time

    Time frame: Pre-dose and up to 48 h post-dose

  9. CL/F

    Total body clearance of drug calculated after extravascular administration (eg, apparent oral clearance)

    Time frame: Pre-dose and up to 48 h post-dose

  10. Vz/F

    Apparent volume of distribution during terminal phase after extravascular administration

    Time frame: Pre-dose and up to 48 h post-dose

  11. Geometric mean erythropoietin Cmax

    Time frame: Pre-dose and up to 24 h post-dose

  12. Geometric mean reticulocyte count

    Time frame: Pre-dose and up to 24 h post-dose

  13. Geometric mean erythrocyte count

    Time frame: Pre-dose and up to 24 h post-dose

  14. Geometric mean reticulocytes/erythrocytes values

    Time frame: Pre-dose and up to 24 h post-dose

  15. Geometric mean hemoglobin values

    Time frame: Pre-dose and up to 24 h post-dose

  16. Geometric mean hematocrit

    Time frame: Pre-dose and up to 24 h post-dose

  17. Geometric mean erythropoietin tmax

    Time frame: Pre-dose and up to 24 h post-dose

  18. Geometric mean erythropoietin AUC(0-24)

    Time frame: Pre-dose and up to 24 h post-dose

07

Study locations

3 sites
  • München, Bavaria 81241, Germany
  • Mönchengladbach, North Rhine-Westphalia 41061, Germany
  • Kiel, Schleswig-Holstein 24105, Germany
08

References and documents

Publications

  • Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2. PubMed 36005278 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01679587
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Sep 6, 2012
Start date
Sep 2012
Primary completion
Feb 2013
Completion
Jul 2013
Last update
May 2, 2016

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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