Trial Condition(s):
Maintenance treatment of anemia in pre-dialysis subjects with chronic kidney disease on darbepoetin treatment versus BAY85-3934 (DIALOGUE 2)
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.
- Male or female subjects ≥ 18 years of age with anemia of chronic kidney disease (CKD) at screening - Estimated glomerular filtration rate (eGFR) of < 60 mL/min/1.73 m2 (Modification of Diet in Renal Disease 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) - Treated with darbepoetin via intravenous (IV) or subcutaneous (SC) route with a weekly, bi-weekly, or monthly dose, having had no more than one dose change within 8 weeks prior to randomization - At least one kidney - Mean screening hemoglobin (Hb) concentration of 10.0 to 12.0 g/dL - Men who agree to use adequate contraception when sexually active or women without childbearing potential
- Subjects with significant acute or chronic bleeding, such as overt gastrointestinal bleeding - Active hemolysis or diagnosis of hemolytic syndrome - History of myelodysplastic syndrome, multiple myeloma, marrow fibrosis, or pure red-cell aplasia (PRCA) - History of hemosiderosis or hemochromatosis - Hereditary hemoglobinopathies (such as sickle cell disease and thalassemia major) - Aplastic anemia - Chronic lymphoproliferative diseases - Proliferative choroidal or retinal disease, such as neovascular age-related macular degeneration or proliferative diabetic retinopathy that is likely to require invasive treatment (intraocular injections or laser photocoagulation) during the study - Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission - Known hypersensitivity to the study drugs (active substances or excipients of the preparations) - Uncontrolled and symptomatic hyperparathyroidism - Uncontrolled active infection - 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 - Any allograft (including renal allograft) in place and on immunosuppressive therapy or a scheduled kidney transplant within the next 16 weeks (being on a waiting list does not exclude the subject)
Locations | Status | ||
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Locations Investigative Site Pavia, Italy, 27100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Cremona, Italy, 26100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Livorno, Italy, 57023 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Reservoir, Australia, 3073 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Gosford, Australia, 2250 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Cambridge, United Kingdom, CB2 0QQ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Liverpool, United Kingdom, L7 8XP | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Nagano, Japan, 388-8004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Kitakyushu, Japan, 802-8555 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Muroran, Japan, 050-0083 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Fukuoka, Japan, 810-8563 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Pecs, Hungary, 7624 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Esztergom, Hungary, 2500 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Baja, Hungary, 6500 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Targu-Mures, Romania, 540103 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Oradea, Romania, 410469 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Pazardjik, Bulgaria, 4400 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Montana, Bulgaria, 3400 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Lovech, Bulgaria, 5500 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Bucheon-si, South Korea, 420-767 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Lecco, Italy, 23900 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Bucharest, Romania, 020475 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Fujisawa, Japan, 251-8550 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Bucharest, Romania, 010731 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site L'Hospitalet de Llobregat, Spain, 08907 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Madrid, Spain, 28007 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site San Sebastián de los Reyes, Spain, 28702 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site PIERRE BENITE CEDEX, France, 69495 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site GRENOBLE CEDEX 9, France, 38043 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Kuwana, Japan, 511-0061 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Kaposvar, Hungary, 7400 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Szigetvar, Hungary, 7900 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Radom, Poland, 26-610 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Okawa, Japan, 831-0016 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Stara Zagora, Bulgaria, 6000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Bialystok, Poland, 15-540 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Chiba, Japan, 260-8712 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Bonn, Germany, 53127 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Morioka, Japan, 020-0066 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Napoli, Italy, 80138 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Kfar Saba, Israel, 4428164 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Ashkelon, Israel, 7827804 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Dobrich, Bulgaria, 9300 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Brescia, Italy, 25123 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Hadera, Israel, 3810101 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Nahariya, Israel, 2210001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Ankara Univ. Medical Faculty Ankara, Turkey, 06100 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Baskent University Medical Faculty Ankara, Turkey, 06490 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Sifa University Medical Faculty IZMIR, Turkey, 03540 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Budapest, Hungary, 1036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Investigative Site Sofia, Bulgaria, 1872 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
4