Trial Condition(s):
Anemia, Renal Insufficiency, Chronic
15141 Fixed dose correction / naïve and pre dialysis (Europe and Asia Pacific) (DIALOGUE 1)
Bayer Identifier:
15141
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
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 </= 10.5 g/dL - 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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Pavia, Italy, 27100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cremona, Italy, 26100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Livorno, Italy, 57023 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gosford, Australia, 2250 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Melbourne, Australia, 3052 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cambridge, United Kingdom, CB2 0QQ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, SE5 9RS | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Doncaster, United Kingdom, DN2 5LT | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kitakyushu, Japan, 802-8555 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Muroran, Japan, 050-0083 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fukuoka, Japan, 810-8563 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Düsseldorf, Germany, 40210 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pecs, Hungary, 7623 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Targu-Mures, Romania, 540103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oradea, Romania, 410469 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pazardjik, Bulgaria, 4400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Veliko Tarnovo, Bulgaria, 5000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Montana, Bulgaria, 3400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lovech, Bulgaria, 5500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bucheon-si, South Korea, 420-767 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Modena, Italy, 41100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bucharest, Romania, 020475 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kamakura, Japan, 247-8533 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site L'Hospitalet de Llobregat, Spain, 08907 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Baja, Hungary, 6500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Constanta, Romania, 900591 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kuwana, Japan, 511-0061 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stara Zagora, Bulgaria, 6000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gabrovo, Bulgaria, 5300 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Okawa, Japan, 831-0016 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Poznan, Poland, 61-858 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Radom, Poland, 26-610 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LIMOGES Cedex1, France, 87042 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bialystok, Poland, 15-540 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chiba, Japan, 260-8712 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Szczecin, Poland, 70-111 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bonn, Germany, 53127 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 156-707 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 156-755 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 03080 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zyrardow, Poland, 96-300 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Malbork, Poland, 82-200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Halle (Saale), Germany, 06097 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hakusan, Japan, 924-8588 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nara, Japan, 630-8581 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Morioka, Japan, 020-0066 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Napoli, Italy, 80138 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ashkelon, Israel, 7827804 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hadera, Israel, 3810101 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nahariya, Israel, 2210001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ankara Univ. Medical Faculty Ankara, Turkey, 06100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Baskent University Medical Faculty Ankara, Turkey, 06490 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sifa University Medical Faculty IZMIR, Turkey, 03540 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Budapest, Hungary, 1036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Villingen-Schwenningen, Germany, 78052 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Santiago de Compostela, Spain, 15706 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
6
Primary Outcome
- Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment periodTimeframe: Baseline and week 12 to 16
Secondary Outcome
- Change in local laboratory hemoglobin level from baselineTimeframe: Baseline up to 12 weeks
- Speed of change in hemoglobin level per unit timeTimeframe: Up to 16 weeks
- Duration of treatment exposureTimeframe: Up to 16 weeks
- Number of participants with serious adverse events as a measure of safety and tolerabilityTimeframe: Up to 16 weeks
- Pharmacodynamics characterized by erythropoietin concentrationTimeframe: Several time points up to 16 weeks
- Pharmacodynamics characterized by reticulocyte countTimeframe: Several time points up to 16 weeks
Additional Information
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