Extension study of BAY 85-3934 in the long-term treatment of anaemia
Research type
Research Study
Full title
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
IRAS ID
138253
Contact name
Iain Macdougall
Contact email
Sponsor organisation
Bayer HealthCare AG
Eudract number
2013-001190-24
ISRCTN Number
n/a
Research summary
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 extension 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 extension study will enroll up to 240 patients at multiple locations in Europe, Asia and Australia. Patients who participated in Studies 15141 or 15261 may be eligible to take part in the extension study. The study consists of the Haemoglobin (Hb) Stabilisation Phase and the Main Phase. The Hb Stabilisation Phase involves up to 10 study visits scheduled over 16 weeks. The Main Phase will last for at least 6 months and up to a maximum of 36 months, with visits every 4 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/0314
Date of REC Opinion
12 Nov 2013
REC opinion
Further Information Favourable Opinion