check_circleStudy Completed

Renal anemia

Bayer Identifier:

14634

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2013-003944-22

EU CT Number:

Not Available
BAY85-3934, Liver impairment study

Trial purpose

The study was conducted in a single-center, non-randomized, non-controlled, nonblinded, observational design with group stratification.

Key Participants Requirements

Sex

All

Age

18 - 79 Years
  • - Male and female white subjects aged between 18 to 79 years with a body mass index (BMI) of 18 to 34 kg/m2;
    - Subjects with hepatic impairment Child Pugh A or B with documented liver cirrhosis confirmed by histopathology, e.g., previous liver biopsy, laparoscopy, ultrasound, or fibroscan;
    - Age, weight and gender matched healthy subjects (mean age and body weight in the control group and in the 2 groups with hepatic impairment were not to vary by more than ± 10 years and ± 10 kg).

  • -

Trial summary

Enrollment Goal
27
Trial Dates
January 2014 - September 2014
Phase
Phase 1
Could I Receive a placebo
No
Products
Musredo (Molidustat, BAY85-3934)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Kiel, 24105, Germany

Trial design

Investigation of pharmacokinetics, pharmacodynamics, safety, and tolerability of molidustat (BAY 85-3934) in subjects with hepatic impairment (classified as Child Pugh A or B) and in age-, weight-, and gender-matched healthy subjects following a single oral dose in a single-center, non-randomized, non-controlled, non-blinded, observational study with group stratification
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Non-randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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