BAY 85-3934 for the treatment of anaemia associated with CKD v placebo

• Research type

  Research Study

• Full title

  A randomized, placebo-controlled, double-blind, parallel group, multicenter study to investigate the efficacy and safety of 5 fixed doses of BAY 85-3934 administered orally in the correction of anemia in erythropoiesis-stimulating agent naïve, pre dialysis subjects with chronic kidney disease in Europe and Asia Pacific

• IRAS ID

  138144

• Contact name

  Iain Macdougall

• Contact email

  iain.macdougall@nhs.net

• Sponsor organisation

  Bayer HealthCare AG

• Eudract number

  2013-001193-14

• ISRCTN Number

  n/a

• Research summary

  After the 4th evaluation visit (Visit 12; at the end of Week 16) of Study 15141, patients will enter into a follow-up period for a duration of 8 weeks. Alternatively, eligible patients will have the option to be enrolled in the Europe and Asia Pacific long-term extension study (Study 15653).

  The study title of 15653 is:
  A controlled, parallel group, open-label, multicenter extension study to investigate efficacy and safety of oral BAY 85-3934 and darbepoetin alfa comparator in the long term treatment of anemia in pre dialysis subjects with chronic kidney disease in Europe and Asia Pacific

  The primary objectives of study 15653 are:
  • To evaluate efficacy of treatment with BAY 85-3934 compared with darbepoetin alfa as measured by the change from baseline to post-baseline time points in haemoglobin (Hb) levels
  • To evaluate safety and tolerability of treatment with BAY 85-3934 compared with darbepoetin by events of special interest, adjudicated serious adverse events (SAEs), and SAEs.

  Study 15653 has been submitted to the same Research Ethics Committee as study 15141 and will be reviewed at the same meeting.
  
  
  
  

  2. OVERVIEW OF THE RESEARCH
  
  

  To provide all the information required by review bodies and research information systems, we ask a number of specific questions. This section invites you to give an overview using language comprehensible to lay reviewers and members of the public. Please read the guidance notes for advice on this section.
  
  

  A6-1. Summary of the study. Please provide a brief summary of the research (maximum 300 words) using language easily understood by lay reviewers and members of the public. Where the research is reviewed by a REC within the UK Health Departments Research Ethics Service, this summary will be published on the website of the National Research Ethics Service following the ethical review.
  Anaemia is a condition in which blood has a lower than normal number of red blood cells. It can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce a hormone called erythropoietin, which stimulates the bone marrow to produce the proper number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is a general term that means that the kidneys are not functioning to their full potential. The study drug, BAY 85-3934, is being evaluated as a drug to increase the body’s ability to produce erythropoietin.

  The purpose of this study is to find out if the study drug, a tablet taken orally, is safe and effective for the treatment of anaemia associated with chronic kidney disease.

  The study will enroll 120 patients at multiple locations in Europe, Asia and Australia. Participation will involve a screening visit and between 12 and 14 study visits scheduled over a period of approximately 5 to 7 months. The estimated total duration of study treatment will be 16 weeks. During these scheduled visits patients will undergo a number of procedures to confirm efficacy and safety of the study drug, including measurement of heart rate and blood pressure, physical examination, Electrocardiogram and blood/urine sample collection for laboratory tests.

  The study will be conducted at 5 hospitals in the UK.

  Bayer HealthCare AG is funding this research.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  13/YH/0313

• Date of REC Opinion

  8 Nov 2013

• REC opinion

  Further Information Favourable Opinion