Trial Condition(s):
Anemia, Renal Insufficiency, Chronic
Long-term pre-dialysis extension in Europe and Asia Pacific (DIALOGUE 3)
Bayer Identifier:
15653
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 extension 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 extension study will enroll up to 240 patients at multiple locations in Europe, Asia and Australia. Patients who participated in Studies 15141 or 15261 may be eligible to take part in the extension study. The study consists of the Haemoglobin (Hb) Stabilisation Phase and the Main Phase. The Hb Stabilisation Phase involves up to 10 study visits scheduled over 16 weeks. The Main Phase will last for at least 6 months and up to a maximum of 36 months, with visits every 4 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.
This study will include subjects who either completed the treatment period in their respective Phase 2 parent study (i.e., Study 15141 or Study 15261) or experienced a stopping event in the fixed dose parent study (Study 15141). As Study 15141 is a double-blind study, subjects will be unblinded as per the Study 15141 protocol prior to entry into the extension study.
Inclusion Criteria
- Men who agree to use adequate contraception when sexually active or women without childbearing potential - Not on dialysis at study entry - Serum ferritin levels ≥ 100 μg/L and < 1000 μg/L or transferrin saturation ≥ 20% - Inclusion criteria for inclusion into the Hb Stabilization (HbS) Phase: Requires Hb stabilization (at 10.0 to 12..0g/dL for a minimum of 4 weeks) as follows: Received BAY 85-3934 and reached a stopping event in Study 15141 or received placebo and reached a stopping event in Study 15141 or completed 16 weeks of treatment with BAY 85-3934 in Study 15141or 15261 but had mean Hb during the evaluation period outside the target range of 10.0 to 12.0 g/dL, or Completed 16 weeks of treatment with placebo in Study 15141 and was re-assessed at 4 weeks after end of study as eligible for Study 15653 (this study) - Inclusion criteria for inclusion into the Main Phase: Mean Hb concentration of 10.0 to 12.0 g/dL who completed 16 weeks of treatment (BAY85-3934 arm) in Study 15141, or completed 16 weeks of treatment (BAY-3934 or darbepoetin arm)in study 15261 without a dose suspension lasting > 6 consecutive weeks, or mean Hb concentration of 10.0 to 12.0g/dL during the HbS phase of Study 15653 for a minimum of 4 weeks after visit 3.
Exclusion Criteria
- A scheduled kidney transplant or any other organ transplant within the next 6 months (being on a waiting list does not exclude the subject) - Red blood cell (RBC) containing transfusion within the 8 weeks before baseline - Phosphodiesterase type 5 (PDE5) inhibitor (e.g., sildenafil, vardenafil, tadalafil) or nitrates - Sustained, poorly controlled arterial hypertension or hypotension at baseline, defined as blood pressure ≥ 180/110 mmHg or systolic blood pressure < 95 mmHg, respectively - Severe rhythm or conduction disorders (e.g., heart rate [HR] < 50 or > 110 bpm, atrial flutter, prolonged QT > 500 msec, second or third degree atrioventricular [AV] block), if not reacted with a pace marker) - New York Heart Association Class III or IV congestive heart failure - Severe hepatic insufficiency (defined as alanine aminotransferase [ALT], aspartate aminotransferase [AST]>3x the upper limit of normal [ULN], total bilirubin > 2 mg/dL, or Child Pugh B or C) or active hepatitis, in the investigator’s opinion - An ongoing serious adverse event (SAE) from Study 15141 or Study 15261 that is assessed as related to study drug
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
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Locations Investigative Site Düsseldorf, Germany, 40210 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pirmasens, Germany, 66953 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Reservoir, Australia, 3073 | 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 Berlin, Germany, 12053 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom | 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 Liverpool, United Kingdom, L7 8XP | 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 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 Milano, Italy, 20132 | 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 Modena, Italy, 41100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pecs, Hungary, 7624 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Debrecen, Hungary, 4032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Esztergom, Hungary, 2500 | 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 Nagano, Japan, 388-8004 | 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 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 Bucharest, Romania, 050098 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Brasov, Romania, 500152 | 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 Sofia, Bulgaria, 1431 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sofia, Bulgaria, 1527 | 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 Chieti, Italy, 66013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lecco, Italy, 23900 | 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 Fujisawa, Japan, 251-8550 | 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 Bucharest, Romania, 010731 | 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 Alicante, Spain, 03010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Córdoba, Spain, 14004 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28007 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Sebastián de los Reyes, Spain, 28702 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sofia, Bulgaria, 1309 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Burgas, Bulgaria, 8000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PIERRE BENITE CEDEX, France, 69495 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site GRENOBLE CEDEX 9, France, 38043 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08036 | 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 Constanta, Romania, 900591 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kaposvar, Hungary, 7400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Szigetvar, Hungary, 7900 | 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 Okawa, Japan, 831-0016 | 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 Wuppertal, Germany, 42283 | 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 Valenciennes, France, 59300 | 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 BREST CEDEX, France, 29609 | 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 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, 631-0846 | 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 Milano, Italy, 20162 | 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 Kfar Saba, Israel, 4428164 | 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 Dobrich, Bulgaria, 9300 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Brescia, Italy, 25123 | 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 Investigative Site Jerusalem, Israel, 9112001 | 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 Santiago de Compostela, Spain, 15706 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Brighton, United Kingdom, BN2 5BE | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Salford, United Kingdom, M5 5AP | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leeds, United Kingdom, WF3 4PX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dundee, United Kingdom, DD1 9SY | 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 Sofia, Bulgaria, 1872 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Karlovo, Bulgaria, 4300 | 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 Chorley, United Kingdom, PR7 7NA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hexham, United Kingdom, NE46 1QJ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Manchester, United Kingdom, M15 6SX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Glasgow, United Kingdom, G20 OSP | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Liverpool, United Kingdom, L22 0LG | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Reading, United Kingdom, RG2 0TG | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A controlled, parallel group, open-label, multicenter extension study to investigate efficacy and safety of oral BAY85-3934 and darbepoetin alfa comparator in the long term treatment of anemia in pre-dialysis subjects with chronic kidney disease in Europe and Asia Pacific
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Change in local laboratory hemoglobin level from baselineTimeframe: Baseline up to 36 months
- Number of participants with serious adverse events (SAEs) and adjucated adverse events as a measure of safety and tolerabilityTimeframe: Up to 36 months
- Number of participants with liver function-related AEs including abnormal liver function tests and any hospitalizationTimeframe: Up to 36 months
Secondary Outcome
- Time within hemoglobin target range (10.0 to 12.0 g/dL)Timeframe: Up to 36 months
- Duration of treatment exposureTimeframe: Up to 36 months
- Number of subjects requiring titration of doseTimeframe: Up to 36 months
- Change of reticulocyte count from baseline of this studyTimeframe: Baseline up to 36 months
- Change of red blood cell count from baseline of this studyTimeframe: Baseline up to 36 months
- Change of hematocrit from baseline of this studyTimeframe: Baseline up to 36 months
- Change of central laboratory hemoglobin level from baseline of this studyTimeframe: Baseline up to 36 months
- Responders in Hb levelsTimeframe: Up to 36 months
- Number of subjects meeting specific Hb criteriaTimeframe: Baseline up to 36 months
- Number of subjects with Hb values >13 g/dL or having excessive Hb increaseTimeframe: Baseline up to 36 months
- Number of participants with non-serious adverse eventsTimeframe: Up to 36 months
- Change in heart rate (HR)Timeframe: Up to 36 months
- Change in blood pressure (BP)Timeframe: Up to 36 months
- Laboratory abnormalitiesTimeframe: Up to 36 months
Additional Information
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