Anemia Clinical Trial
Official title:
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)
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
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