15141 Fixed Dose Correction / naïve and Pre Dialysis (Europe and Asia Pacific)
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Anemia |
| Therapuetic Areas: | Hematology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2014 |
| End Date: | September 2015 |
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.
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.
Inclusion Criteria:
- Women without childbearing potential
- Male or female subjects ≥ 18 years of age with anemia of chronic kidney disease (CKD)
at screening
- Estimated glomerular filtration rate of < 60 mL/min/1.73 m2 (Modification of Diet in
Renal Disease [MDRD] or the formula according to Matsuo, et al)
- Not on dialysis and not expected to begin dialysis during the treatment period of the
study (at least 16 weeks from randomization)
- Not treated with any erythropoiesis-stimulating agent (ESA) within 8 weeks before
randomization
- Mean screening Hb concentration
- Body weight of 45 kg to 125 kg, inclusive, at screening
Exclusion Criteria:
- Subjects with significant acute or chronic bleeding, such as overt gastrointestinal
bleeding
- Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus
erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in
remission
- Previous or concurrent cancer except cervical carcinoma in situ, treated basal cell
carcinoma, superficial bladder tumors (Ta, Tis, and T1) or any cancer curatively
treated > 3 years prior to randomization
- Subjects treated with any ESA within the 8 weeks before randomization
- Red blood cell (RBC) containing transfusion within the 8 weeks before randomization
- History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial
infarction, stroke, transient ischemic attack, deep vein thrombosis, pulmonary
embolism) within the last 6 months from initial screening visit
- Severe rhythm or conduction disorders (e.g., HR < 50 or > 110 bpm, atrial flutter,
prolonged QT > 500 msec, third degree atrioventricular [AV] block)
- New York Heart Association Class III or IV congestive heart failure
- Severe hepatic insufficiency (defined as alanine aminotransferase [ALT] or aspartate
aminotransferase [AST] > 3 x the upper limit of normal [ULN], total bilirubin > 2
mg/dL, or Child-Pugh B and C) or active hepatitis, in the investigator's opinion
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