Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00008817

Trial Description

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Title

Investigation of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Single Oral Doses of 75 mg Molidustat in Male and Female Subjects With Renal Impairment Requiring Hemo- or Peritoneal Dialysis Compared to Age- and Weight-matched Healthy Subjects in a Single-center, Non-controlled, Non-blinded Study With Group Stratification

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The study investigates the pharmacokinetics (absorption, distribution, elimination) of
molidustat after intake of a single 75 mg tablet in subjects with renal impairment requiring
hemo- or peritoneal dialysis compared to age-and gender-matched healthy subjects. In
addition, the effect of molidustat on the hormone erythropoietin will be evaluated as well
as the safety and tolerability of molidustat.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00008817
  •   2015/08/12
  •   2014/12/05
  •   no
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Secondary IDs

  •   2014-003292-31 
  •   NCT02312973  (ClinicalTrials.gov)
  •   17767  (Bayer)
  •   2014-003292-31 
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Health Condition or Problem studied

  •   Renal Insufficiency, Chronic
  •   N18.9 -  Chronic kidney disease, unspecified
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Interventions/Observational Groups

  •   Drug: Molidustat(BAY85-3934)
  •   Drug: Molidustat(BAY85-3934)
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Crossover
  •   I
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Primary Outcome

- Pharmacokinetics characterized by Cmax of Molidustat; time frame: Up to 96 hours post dose; Cmax: maximum drug concentration in plasma after single dose administration
- Pharmacokinetics characterized by AUC of Molidustat; time frame: Up to 96 hours post dose; AUC: area under the plasma concentration vs time curve from zero to infinity
- Pharmacokinetics characterized by Cmax,norm of Molidustat; time frame: Up to 96 hours post dose; Cmax,norm;maximum drug concentration in plasma after single dose administration divided by dose (milligrams) per kilogram body weight
- Pharmacokinetics characterized by (AUCnorm) of Molidustat; time frame: Up to 96 hours post dose; AUCnorm; area under the plasma concentration vs time curve divided by dose per kg body weight

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Secondary Outcome

- Pharmacokinetics characterized by Cmax of erythropoietin; time frame: Up to 48 hours post dose; Cmax: maximum drug concentration in plasma after single dose administration
- Pharmacokinetics characterized by AUC (0-tlast) of erythropoietin; time frame: Up to 48 hours post dose; AUC(0-tlast): AUC from time 0 to the last data point above lower limit of quantification
- Pharmacokinetics characterized by tmax of erythropoietin; time frame: Up to 48 hours post dose; tmax: time to reach maximum drug concentration in plasma after single (first) dose
- Number of subjects with Treatment Emergent Adverse Event (TEAE); time frame: Up to 7 days post dose

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2014/12/31
  •   32
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   79   Years
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Additional Inclusion Criteria

- Male and female (without childbearing potential)

- Age: ≥18 and ≤79 years of age

- Body mass index (BMI): ≥18 and ≤34 kg/m2

- Ethnicity: White

- Subjects with severe renal impairment on hemodialysis or peritoneal dialysis, and

- Healthy subjects

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Exclusion Criteria

- Women of childbearing potential, pregnant or lactating women

- Use of medication within the 2 weeks preceding the study which could interfere with
the investigational product

- Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus
antibodies (HCV Ab), human immune deficiency virus 1 and 2 antibodies (HIV 1/2 Ab)

- Exclusion periods from other studies or simultaneous participation in other clinical
studies

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Addresses

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    • Bayer
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    • Bayer
    • Bayer Study Director 
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    • Bayer Clinical Trials Contact 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2015/06/17
* This entry means the parameter is not applicable or has not been set.