BAY 85-3935 dose escalation study in patients with renal anaemia

• Research type

  Research Study

• Full title

  Randomized, double-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).

• IRAS ID

  70365

• Contact name

  Iain Macdougall

• Sponsor organisation

  Bayer HealthCare AG

• Eudract number

  2010-023585-50

• ISRCTN Number

  Not known

• Research summary

  The drug that is under investigation during this study is BAY 85-3934 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. 48 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 four dose steps.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  11/H0803/4

• Date of REC Opinion

  6 Apr 2011

• REC opinion

  Further Information Favourable Opinion