check_circleStudy Completed
Anemia, Renal Insufficiency, Chronic
Bayer Identifier:
15261
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Maintenance treatment of anemia in pre-dialysis subjects with chronic kidney disease on darbepoetin treatment versus BAY85-3934
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 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.
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.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
126Trial Dates
January 2014 - November 2015Phase
Phase 2Could I Receive a placebo
NoProducts
Molidustat (BAY85-3934)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Pavia, 27100, Italy | |
Completed | Cremona, 26100, Italy | |
Withdrawn | Milano, 20132, Italy | |
Completed | Livorno, 57023, Italy | |
Completed | Reservoir, 3073, Australia | |
Completed | Gosford, 2250, Australia | |
Withdrawn | Melbourne, 3052, Australia | |
Withdrawn | London, United Kingdom | |
Completed | Cambridge, CB2 0QQ, United Kingdom | |
Completed | Liverpool, L7 8XP, United Kingdom | |
Completed | Nagano, 388-8004, Japan | |
Completed | Kitakyushu, 802-8555, Japan | |
Completed | Muroran, 050-0083, Japan | |
Completed | Fukuoka, 810-8563, Japan | |
Withdrawn | Düsseldorf, 40210, Germany | |
Withdrawn | Berlin, 12053, Germany | |
Completed | Pecs, 7624, Hungary | |
Withdrawn | Debrecen, 4032, Hungary | |
Completed | Esztergom, 2500, Hungary | |
Completed | Baja, 6500, Hungary | |
Completed | Targu-Mures, 540103, Romania | |
Completed | Oradea, 410469, Romania | |
Withdrawn | Bucharest, 050098, Romania | |
Withdrawn | Brasov, 500152, Romania | |
Completed | Pazardjik, 4400, Bulgaria | |
Withdrawn | Veliko Tarnovo, 5000, Bulgaria | |
Completed | Montana, 3400, Bulgaria | |
Completed | Lovech, 5500, Bulgaria | |
Withdrawn | Sofia, 1431, Bulgaria | |
Withdrawn | Sofia, 1527, Bulgaria | |
Completed | Bucheon-si, 420-767, Korea, Republic Of | |
Withdrawn | Chieti, 66013, Italy | |
Completed | Lecco, 23900, Italy | |
Completed | Bucharest, 020475, Romania | |
Completed | Fujisawa, 251-8550, Japan | |
Withdrawn | Kamakura, 247-8533, Japan | |
Completed | Bucharest, 010731, Romania | |
Completed | L'Hospitalet de Llobregat, 08907, Spain | |
Withdrawn | Alicante, 03010, Spain | |
Withdrawn | Córdoba, 14004, Spain | |
Withdrawn | Madrid, 28041, Spain | |
Completed | Madrid, 28007, Spain | |
Completed | San Sebastián de los Reyes, 28702, Spain | |
Withdrawn | Burgas, 8000, Bulgaria | |
Completed | PIERRE BENITE CEDEX, 69495, France | |
Withdrawn | PARIS CEDEX 15, 75908, France | |
Completed | GRENOBLE CEDEX 9, 38043, France | |
Withdrawn | PERPIGNAN CEDEX 9, 66046, France | |
Withdrawn | MARSEILLE CEDEX 5, 13385, France | |
Withdrawn | REIMS cedex, 51092, France | |
Withdrawn | Barcelona, 08035, Spain | |
Withdrawn | Barcelona, 08036, Spain | |
Completed | Kuwana, 511-0061, Japan | |
Completed | Kaposvar, 7400, Hungary | |
Completed | Szigetvar, 7900, Hungary | |
Withdrawn | Poznan, 61-858, Poland | |
Completed | Radom, 26-610, Poland | |
Completed | Okawa, 831-0016, Japan | |
Completed | Stara Zagora, 6000, Bulgaria | |
Withdrawn | Gabrovo, 5300, Bulgaria | |
Withdrawn | Wuppertal, 42283, Germany | |
Completed | Bialystok, 15-540, Poland | |
Completed | Chiba, 260-8712, Japan | |
Withdrawn | Valenciennes, 59300, France | |
Withdrawn | LIMOGES Cedex1, 87042, France | |
Withdrawn | BREST CEDEX, 29609, France | |
Completed | Bonn, 53127, Germany | |
Withdrawn | Halle (Saale), 06097, Germany | |
Withdrawn | Nara, 630-8581, Japan | |
Completed | Morioka, 020-0066, Japan | |
Withdrawn | Milano, 20162, Italy | |
Completed | Napoli, 80138, Italy | |
Completed | Kfar Saba, 4428164, Israel | |
Completed | Ashkelon, 7827804, Israel | |
Completed | Dobrich, 9300, Bulgaria | |
Completed | Brescia, 25123, Italy | |
Completed | Hadera, 3810101, Israel | |
Completed | Nahariya, 2210001, Israel | |
Withdrawn | 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 |
Withdrawn | Santiago de Compostela, 15706, Spain | |
Withdrawn | Stoke-on-Trent, ST4 6QG, United Kingdom | |
Withdrawn | Brighton, BN2 5BE, United Kingdom | |
Withdrawn | Salford, M6 8HD, United Kingdom | |
Withdrawn | Leeds, WF3 4PX, United Kingdom | |
Withdrawn | Dundee, DD1 9SY, United Kingdom | |
Completed | Budapest, 1036, Hungary | |
Completed | Sofia, 1872, Bulgaria | |
Withdrawn | Karlovo, 4300, Bulgaria |
Primary Outcome
- Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment perioddate_rangeTime Frame:Baseline and week 12 to 16enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Maintenance in hemoglobin target range (10.0 to 12.0 g/dL)date_rangeTime Frame:Up to 16 weeksenhanced_encryptionNoSafety Issue:
- Change in hemoglobin leveldate_rangeTime Frame:Baseline up to 16 weeksenhanced_encryptionNoSafety Issue:
- Number of patients with hemoglobin levels outside the target rangedate_rangeTime Frame:Week 12 to 16enhanced_encryptionNoSafety Issue:
- Dose level in the evaluation perioddate_rangeTime Frame:Week 12 to 16enhanced_encryptionNoSafety Issue:
- Duration of exposure on each dose leveldate_rangeTime Frame:Up to 16 weeksenhanced_encryptionNoSafety Issue:
- Number of subjects requiring titration of dosedate_rangeTime Frame:Up to 16 weeksenhanced_encryptionNoSafety Issue:
- Number of participants with serious adverse events as a measure of safety and tolerabilitydate_rangeTime Frame:Up to 16 weeksenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
4Additional Information
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