check_circleStudy Completed
Anemia, Renal Insufficiency, Chronic
Bayer Identifier:
15653
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Long-term pre-dialysis extension in Europe and Asia Pacific
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.
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.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
166Trial Dates
June 2014 - December 2016Phase
Phase 2Could I Receive a placebo
NoProducts
Molidustat (BAY85-3934)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Düsseldorf, 40210, Germany | |
Terminated | Pirmasens, 66953, Germany | |
Terminated | Reservoir, 3073, Australia | |
Terminated | Gosford, 2250, Australia | |
Terminated | Melbourne, 3052, Australia | |
Terminated | Berlin, 12053, Germany | |
Terminated | London, United Kingdom | |
Terminated | Cambridge, CB2 0QQ, United Kingdom | |
Terminated | Liverpool, L7 8XP, United Kingdom | |
Completed | London, SE5 9RS, United Kingdom | |
Completed | Doncaster, DN2 5LT, United Kingdom | |
Completed | Pavia, 27100, Italy | |
Completed | Cremona, 26100, Italy | |
Terminated | Milano, 20132, Italy | |
Completed | Livorno, 57023, Italy | |
Terminated | Modena, 41100, Italy | |
Completed | Pecs, 7624, Hungary | |
Terminated | Debrecen, 4032, Hungary | |
Completed | Esztergom, 2500, Hungary | |
Completed | Baja, 6500, Hungary | |
Completed | Nagano, 388-8004, Japan | |
Completed | Kitakyushu, 802-8555, Japan | |
Completed | Muroran, 050-0083, Japan | |
Completed | Fukuoka, 810-8563, Japan | |
Terminated | Targu-Mures, 540103, Romania | |
Completed | Oradea, 410469, Romania | |
Terminated | Bucharest, 050098, Romania | |
Terminated | Brasov, 500152, Romania | |
Terminated | Pazardjik, 4400, Bulgaria | |
Completed | Veliko Tarnovo, 5000, Bulgaria | |
Completed | Montana, 3400, Bulgaria | |
Completed | Lovech, 5500, Bulgaria | |
Terminated | Sofia, 1431, Bulgaria | |
Terminated | Sofia, 1527, Bulgaria | |
Completed | Bucheon-si, 420-767, Korea, Republic Of | |
Terminated | Chieti, 66013, Italy | |
Completed | Lecco, 23900, Italy | |
Completed | Bucharest, 020475, Romania | |
Terminated | Fujisawa, 251-8550, Japan | |
Terminated | Kamakura, 247-8533, Japan | |
Completed | Bucharest, 010731, Romania | |
Completed | L'Hospitalet de Llobregat, 08907, Spain | |
Terminated | Alicante, 03010, Spain | |
Terminated | Córdoba, 14004, Spain | |
Terminated | Madrid, 28041, Spain | |
Completed | Madrid, 28007, Spain | |
Completed | San Sebastián de los Reyes, 28702, Spain | |
Terminated | Sofia, 1309, Bulgaria | |
Terminated | Burgas, 8000, Bulgaria | |
Completed | PIERRE BENITE CEDEX, 69495, France | |
Completed | GRENOBLE CEDEX 9, 38043, France | |
Terminated | Barcelona, 08035, Spain | |
Terminated | Barcelona, 08036, Spain | |
Completed | Kuwana, 511-0061, Japan | |
Completed | Constanta, 900591, Romania | |
Completed | Kaposvar, 7400, Hungary | |
Terminated | Szigetvar, 7900, Hungary | |
Completed | Poznan, 61-858, Poland | |
Completed | Radom, 26-610, Poland | |
Completed | Okawa, 831-0016, Japan | |
Completed | Stara Zagora, 6000, Bulgaria | |
Terminated | Gabrovo, 5300, Bulgaria | |
Terminated | Wuppertal, 42283, Germany | |
Completed | Bialystok, 15-540, Poland | |
Completed | Chiba, 260-8712, Japan | |
Terminated | Valenciennes, 59300, France | |
Completed | LIMOGES Cedex1, 87042, France | |
Terminated | BREST CEDEX, 29609, France | |
Completed | Szczecin, 70-111, Poland | |
Terminated | Bonn, 53127, Germany | |
Completed | Seoul, 156-707, Korea, Republic Of | |
Completed | Seoul, 156-755, Korea, Republic Of | |
Completed | Seoul, 03080, Korea, Republic Of | |
Terminated | Zyrardow, 96-300, Poland | |
Terminated | Halle (Saale), 06097, Germany | |
Completed | Hakusan, 924-8588, Japan | |
Completed | Nara, 631-0846, Japan | |
Completed | Morioka, 020-0066, Japan | |
Terminated | Milano, 20162, Italy | |
Completed | Napoli, 80138, Italy | |
Terminated | Kfar Saba, 4428164, Israel | |
Completed | Ashkelon, 7827804, Israel | |
Completed | Dobrich, 9300, Bulgaria | |
Completed | Brescia, 25123, Italy | |
Completed | Hadera, 3810101, Israel | |
Terminated | Nahariya, 2210001, Israel | |
Terminated | Jerusalem, 9112001, Israel | |
Terminated | Ankara Univ. Medical Faculty | Ankara, 06100, Turkey |
Terminated | Baskent University Medical Faculty | Ankara, 06490, Turkey |
Terminated | Sifa University Medical Faculty | IZMIR, 03540, Turkey |
Terminated | Santiago de Compostela, 15706, Spain | |
Terminated | Brighton, BN2 5BE, United Kingdom | |
Terminated | Salford, M5 5AP, United Kingdom | |
Terminated | Leeds, WF3 4PX, United Kingdom | |
Terminated | Dundee, DD1 9SY, United Kingdom | |
Completed | Budapest, 1036, Hungary | |
Completed | Sofia, 1872, Bulgaria | |
Terminated | Karlovo, 4300, Bulgaria | |
Completed | Villingen-Schwenningen, 78052, Germany | |
Terminated | Chorley, PR7 7NA, United Kingdom | |
Terminated | Hexham, NE46 1QJ, United Kingdom | |
Terminated | Manchester, M15 6SX, United Kingdom | |
Terminated | Glasgow, G20 OSP, United Kingdom | |
Terminated | Liverpool, L22 0LG, United Kingdom | |
Terminated | Reading, RG2 0TG, United Kingdom |
Primary Outcome
- Change in local laboratory hemoglobin level from baselinedate_rangeTime Frame:Baseline up to 36 monthsenhanced_encryptionNoSafety Issue:
- Number of participants with serious adverse events (SAEs) and adjucated adverse events as a measure of safety and tolerabilitydate_rangeTime Frame:Up to 36 monthsenhanced_encryptionYesSafety Issue:
- Number of participants with liver function-related AEs including abnormal liver function tests and any hospitalizationdate_rangeTime Frame:Up to 36 months
Secondary Outcome
- Time within hemoglobin target range (10.0 to 12.0 g/dL)date_rangeTime Frame:Up to 36 monthsenhanced_encryptionNoSafety Issue:
- Duration of treatment exposuredate_rangeTime Frame:Up to 36 monthsenhanced_encryptionNoSafety Issue:
- Number of subjects requiring titration of dosedate_rangeTime Frame:Up to 36 monthsenhanced_encryptionNoSafety Issue:
- Change of reticulocyte count from baseline of this studydate_rangeTime Frame:Baseline up to 36 monthsenhanced_encryptionNoSafety Issue:
- Change of red blood cell count from baseline of this studydate_rangeTime Frame:Baseline up to 36 monthsenhanced_encryptionNoSafety Issue:
- Change of hematocrit from baseline of this studydate_rangeTime Frame:Baseline up to 36 monthsenhanced_encryptionNoSafety Issue:
- Change of central laboratory hemoglobin level from baseline of this studydate_rangeTime Frame:Baseline up to 36 monthsenhanced_encryptionNoSafety Issue:
- Responders in Hb levelsdate_rangeTime Frame:Up to 36 months
- Number of subjects meeting specific Hb criteriadate_rangeTime Frame:Baseline up to 36 months
- Number of subjects with Hb values >13 g/dL or having excessive Hb increasedate_rangeTime Frame:Baseline up to 36 months
- Number of participants with non-serious adverse eventsdate_rangeTime Frame:Up to 36 months
- Change in heart rate (HR)date_rangeTime Frame:Up to 36 months
- Change in blood pressure (BP)date_rangeTime Frame:Up to 36 months
- Laboratory abnormalitiesdate_rangeTime Frame:Up to 36 months
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2Additional Information
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