Long-term Pre-dialysis Extension in Europe and Asia Pacific
Status:
Completed
Trial end date:
2016-12-12
Target enrollment:
Participant gender:
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, BAY85-3934, 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. This study will include subjects who either completed the treatment period in their
respective Phase 2 parent study (i.e., Study 15141 or Study 15261) or experienced a stopping
event in the fixed dose parent study (Study 15141). As Study 15141 is a double-blind study,
subjects will be unblinded as per the Study 15141 protocol prior to entry into the extension
study.