Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Parallel Group, Open-label, Multicenter Study to Investigate the Efficacy and Safety of Oral BAY85-3934 and Active Comparator (Darbepoetin Alfa) in the Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment in Europe and Asia Pacific
Brief 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 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 15 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 3 hospitals in the UK. Bayer HealthCare AG is funding this research.


Options:
A: Arm Label: Roxadustat; Type: EXPERIMENTAL; Interventions: Drug: Roxadustat | Arm Label: Epoetin Alfa; Type: ACTIVE_COMPARATOR; Interventions: Drug: Epoetin Alfa | Intervention Type: DRUG; Name: Epoetin Alfa; Assigned to Arm(s): Epoetin Alfa | Intervention Type: DRUG; Name: Roxadustat; Assigned to Arm(s): Roxadustat
B: Arm Label: Daprodustat; Type: EXPERIMENTAL; Interventions: Drug: Daprodustat small, Drug: Daprodustat large, Drug: Darbepoetin alfa placebo | Arm Label: Darbepoetin alfa; Type: ACTIVE_COMPARATOR; Interventions: Drug: Daprodustat small placebo, Drug: Daprodustat large placebo, Drug: Darbepoetin alfa | Intervention Type: DRUG; Name: Daprodustat small; Assigned to Arm(s): Daprodustat | Intervention Type: DRUG; Name: Daprodustat small placebo; Assigned to Arm(s): Darbepoetin alfa | Intervention Type: DRUG; Name: Daprodustat large; Assigned to Arm(s): Daprodustat | Intervention Type: DRUG; Name: Daprodustat large placebo; Assigned to Arm(s): Darbepoetin alfa | Intervention Type: DRUG; Name: Darbepoetin alfa; Assigned to Arm(s): Darbepoetin alfa | Intervention Type: DRUG; Name: Darbepoetin alfa placebo; Assigned to Arm(s): Daprodustat
C: Arm Label: BAY85-3934 (25mg); Type: EXPERIMENTAL; Interventions: Drug: BAY85-3934 | Arm Label: BAY85-3934 (50mg); Type: EXPERIMENTAL; Interventions: Drug: BAY85-3934 | Arm Label: BAY85-3934 (75mg); Type: EXPERIMENTAL; Interventions: Drug: BAY85-3934 | Arm Label: Darbepoetin alfa; Type: ACTIVE_COMPARATOR; Interventions: Biological: Darbepoetin alfa | Intervention Type: DRUG; Name: BAY85-3934; Assigned to Arm(s): BAY85-3934 (25mg), BAY85-3934 (50mg), BAY85-3934 (75mg) | Intervention Type: BIOLOGICAL; Name: Darbepoetin alfa; Assigned to Arm(s): Darbepoetin alfa
D: Arm Label: AKB-6548 240 mg; Type: EXPERIMENTAL; Interventions: Drug: AKB-6548 | Arm Label: AKB-6548 370 mg; Type: EXPERIMENTAL; Interventions: Drug: AKB-6548 | Arm Label: AKB-6548 500 mg; Type: EXPERIMENTAL; Interventions: Drug: AKB-6548 | Arm Label: AKB-6548 630 mg; Type: EXPERIMENTAL; Interventions: Drug: AKB-6548 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: AKB-6548; Assigned to Arm(s): AKB-6548 240 mg, AKB-6548 370 mg, AKB-6548 500 mg, AKB-6548 630 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: C