Anemia Clinical Trial
Official title:
A Randomized, Placebo-controlled, Double-blind, Parallel Group, Multicenter Study to Investigate the Efficacy and Safety of 5 Fixed Doses of BAY85-3934 Administered Orally in the Correction of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease Not Currently Treated With Erythropoiesis-stimulating Agent in Europe and Asia Pacific
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 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.
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