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:

NCT02021370

EudraCT Number:

2013-001193-14

Study Completed

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
121
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Molidustat (BAY85-3934)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Pavia, Italy, 27100

Status
Completed
 
Locations

Investigative Site

Cremona, Italy, 26100

Status
Completed
 
Locations

Investigative Site

Livorno, Italy, 57023

Status
Completed
 
Locations

Investigative Site

Gosford, Australia, 2250

Status
Completed
 
Locations

Investigative Site

Melbourne, Australia, 3052

Status
Completed
 
Locations

Investigative Site

Cambridge, United Kingdom, CB2 0QQ

Status
Completed
 
Locations

Investigative Site

London, United Kingdom, SE5 9RS

Status
Completed
 
Locations

Investigative Site

Doncaster, United Kingdom, DN2 5LT

Status
Completed
 
Locations

Investigative Site

Kitakyushu, Japan, 802-8555

Status
Completed
 
Locations

Investigative Site

Muroran, Japan, 050-0083

Status
Completed
 
Locations

Investigative Site

Fukuoka, Japan, 810-8563

Status
Completed
 
Locations

Investigative Site

Düsseldorf, Germany, 40210

Status
Completed
 
Locations

Investigative Site

Pecs, Hungary, 7623

Status
Completed
 
Locations

Investigative Site

Targu-Mures, Romania, 540103

Status
Completed
 
Locations

Investigative Site

Oradea, Romania, 410469

Status
Completed
 
Locations

Investigative Site

Pazardjik, Bulgaria, 4400

Status
Completed
 
Locations

Investigative Site

Veliko Tarnovo, Bulgaria, 5000

Status
Completed
 
Locations

Investigative Site

Montana, Bulgaria, 3400

Status
Completed
 
Locations

Investigative Site

Lovech, Bulgaria, 5500

Status
Completed
 
Locations

Investigative Site

Bucheon-si, South Korea, 420-767

Status
Completed
 
Locations

Investigative Site

Modena, Italy, 41100

Status
Completed
 
Locations

Investigative Site

Bucharest, Romania, 020475

Status
Completed
 
Locations

Investigative Site

Kamakura, Japan, 247-8533

Status
Completed
 
Locations

Investigative Site

L'Hospitalet de Llobregat, Spain, 08907

Status
Completed
 
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Investigative Site

Baja, Hungary, 6500

Status
Completed
 
Locations

Investigative Site

Constanta, Romania, 900591

Status
Completed
 
Locations

Investigative Site

Kuwana, Japan, 511-0061

Status
Completed
 
Locations

Investigative Site

Stara Zagora, Bulgaria, 6000

Status
Completed
 
Locations

Investigative Site

Gabrovo, Bulgaria, 5300

Status
Completed
 
Locations

Investigative Site

Okawa, Japan, 831-0016

Status
Completed
 
Locations

Investigative Site

Poznan, Poland, 61-858

Status
Completed
 
Locations

Investigative Site

Radom, Poland, 26-610

Status
Completed
 
Locations

Investigative Site

LIMOGES Cedex1, France, 87042

Status
Completed
 
Locations

Investigative Site

Bialystok, Poland, 15-540

Status
Completed
 
Locations

Investigative Site

Chiba, Japan, 260-8712

Status
Completed
 
Locations

Investigative Site

Szczecin, Poland, 70-111

Status
Completed
 
Locations

Investigative Site

Bonn, Germany, 53127

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 156-707

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 156-755

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 03080

Status
Completed
 
Locations

Investigative Site

Zyrardow, Poland, 96-300

Status
Completed
 
Locations

Investigative Site

Malbork, Poland, 82-200

Status
Completed
 
Locations

Investigative Site

Halle (Saale), Germany, 06097

Status
Completed
 
Locations

Investigative Site

Hakusan, Japan, 924-8588

Status
Completed
 
Locations

Investigative Site

Nara, Japan, 630-8581

Status
Completed
 
Locations

Investigative Site

Morioka, Japan, 020-0066

Status
Completed
 
Locations

Investigative Site

Napoli, Italy, 80138

Status
Completed
 
Locations

Investigative Site

Ashkelon, Israel, 7827804

Status
Completed
 
Locations

Investigative Site

Hadera, Israel, 3810101

Status
Completed
 
Locations

Investigative Site

Nahariya, Israel, 2210001

Status
Completed
 
Locations

Ankara Univ. Medical Faculty

Ankara, Turkey, 06100

Status
Terminated
 
Locations

Baskent University Medical Faculty

Ankara, Turkey, 06490

Status
Terminated
 
Locations

Sifa University Medical Faculty

IZMIR, Turkey, 03540

Status
Terminated
 
Locations

Investigative Site

Budapest, Hungary, 1036

Status
Completed
 
Locations

Investigative Site

Villingen-Schwenningen, Germany, 78052

Status
Completed
 
Locations

Investigative Site

Santiago de Compostela, Spain, 15706

Status
Completed
 

Trial Design