Back to results15141 Fixed Dose Correction / naïve and Pre Dialysis (Europe and Asia Pacific) (DIALOGUE 1)
Primary Purpose
Anemia, Renal Insufficiency, Chronic
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BAY85-3934
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring Anemia of CKD
Eligibility Criteria
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
Sites / Locations
- Ankara Univ. Medical Faculty
- Baskent University Medical Faculty
- Sifa University Medical Faculty
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
BAY85-3934 (25mg OD)
BAY85-3934 (50mg OD)
BAY85-3934 (75mg OD)
BAY85-3934 (25mg BID)
BAY85-3934 (50mg BID)
Placebo BID
Arm Description
25 mg once daily (OD) of BAY85-3934 Morning: 1 tablet BAY85-3934 25 mg and 2 tablets matching placebo Evening: 3 tablets matching placebo
50 mg OD of BAY85-3934 Morning: 2 tablets BAY85-3934 25 mg and 1 tablet matching placebo Evening: 3 tablets matching placebo
75 mg OD of BAY85-3934 Morning: 3 tablets BAY85-3934 25 mg Evening: 3 tablets matching placebo
25 mg twice daily (BID) of BAY85-3934 Morning and evening: 1 tablet BAY85-3934 25 mg and 2 tablets matching placebo
50 mg BID of BAY85-3934 Morning and evening: 2 tablets BAY85-3934 25 mg and 1 tablet matching placebo
Placebo BID Morning and evening: 3 tablets of placebo matching BAY85-3934 25 mg
Outcomes
Primary Outcome Measures
Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period
Secondary Outcome Measures
Change in local laboratory hemoglobin level from baseline
Speed of change in hemoglobin level per unit time
Duration of treatment exposure
Number of participants with serious adverse events as a measure of safety and tolerability
Pharmacodynamics characterized by erythropoietin concentration
Pharmacodynamics characterized by reticulocyte count
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02021370
Brief Title
15141 Fixed Dose Correction / naïve and Pre Dialysis (Europe and Asia Pacific)
Acronym
DIALOGUE 1
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 10, 2014 (Actual)
Primary Completion Date
September 15, 2015 (Actual)
Study Completion Date
September 23, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Renal Insufficiency, Chronic
Keywords
Anemia of CKD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BAY85-3934 (25mg OD)
Arm Type
Experimental
Arm Description
25 mg once daily (OD) of BAY85-3934 Morning: 1 tablet BAY85-3934 25 mg and 2 tablets matching placebo Evening: 3 tablets matching placebo
Arm Title
BAY85-3934 (50mg OD)
Arm Type
Experimental
Arm Description
50 mg OD of BAY85-3934 Morning: 2 tablets BAY85-3934 25 mg and 1 tablet matching placebo Evening: 3 tablets matching placebo
Arm Title
BAY85-3934 (75mg OD)
Arm Type
Experimental
Arm Description
75 mg OD of BAY85-3934 Morning: 3 tablets BAY85-3934 25 mg Evening: 3 tablets matching placebo
Arm Title
BAY85-3934 (25mg BID)
Arm Type
Experimental
Arm Description
25 mg twice daily (BID) of BAY85-3934 Morning and evening: 1 tablet BAY85-3934 25 mg and 2 tablets matching placebo
Arm Title
BAY85-3934 (50mg BID)
Arm Type
Experimental
Arm Description
50 mg BID of BAY85-3934 Morning and evening: 2 tablets BAY85-3934 25 mg and 1 tablet matching placebo
Arm Title
Placebo BID
Arm Type
Placebo Comparator
Arm Description
Placebo BID Morning and evening: 3 tablets of placebo matching BAY85-3934 25 mg
Intervention Type
Drug
Intervention Name(s)
BAY85-3934
Intervention Description
25mg Tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablet
Primary Outcome Measure Information:
Title
Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period
Time Frame
Baseline and week 12 to 16
Secondary Outcome Measure Information:
Title
Change in local laboratory hemoglobin level from baseline
Time Frame
Baseline up to 12 weeks
Title
Speed of change in hemoglobin level per unit time
Time Frame
Up to 16 weeks
Title
Duration of treatment exposure
Time Frame
Up to 16 weeks
Title
Number of participants with serious adverse events as a measure of safety and tolerability
Time Frame
Up to 16 weeks
Title
Pharmacodynamics characterized by erythropoietin concentration
Time Frame
Several time points up to 16 weeks
Title
Pharmacodynamics characterized by reticulocyte count
Time Frame
Several time points up to 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
City
Lovech
ZIP/Postal Code
5500
Country
Bulgaria
City
Montana
ZIP/Postal Code
3400
Country
Bulgaria
City
Pazardjik
ZIP/Postal Code
4400
Country
Bulgaria
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
City
Limoges Cedex1
ZIP/Postal Code
87042
Country
France
City
Villingen-Schwenningen
State/Province
Baden-Württemberg
ZIP/Postal Code
78052
Country
Germany
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53127
Country
Germany
City
Düsseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40210
Country
Germany
City
Halle (Saale)
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06097
Country
Germany
City
Baja
ZIP/Postal Code
6500
Country
Hungary
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
City
Pecs
ZIP/Postal Code
7623
Country
Hungary
City
Ashkelon
ZIP/Postal Code
7827804
Country
Israel
City
Hadera
ZIP/Postal Code
3810101
Country
Israel
City
Nahariya
ZIP/Postal Code
2210001
Country
Israel
City
Napoli
State/Province
Campania
ZIP/Postal Code
80138
Country
Italy
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41100
Country
Italy
City
Cremona
State/Province
Lombardia
ZIP/Postal Code
26100
Country
Italy
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
City
Livorno
State/Province
Toscana
ZIP/Postal Code
57023
Country
Italy
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
802-8555
Country
Japan
City
Okawa
State/Province
Fukuoka
ZIP/Postal Code
831-0016
Country
Japan
City
Muroran
State/Province
Hokkaido
ZIP/Postal Code
050-0083
Country
Japan
City
Hakusan
State/Province
Ishikawa
ZIP/Postal Code
924-8588
Country
Japan
City
Morioka
State/Province
Iwate
ZIP/Postal Code
020-0066
Country
Japan
City
Kamakura
State/Province
Kanagawa
ZIP/Postal Code
247-8533
Country
Japan
City
Kuwana
State/Province
Mie
ZIP/Postal Code
511-0061
Country
Japan
City
Chiba
ZIP/Postal Code
260-8712
Country
Japan
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
City
Nara
ZIP/Postal Code
630-8581
Country
Japan
City
Bucheon-si
State/Province
Gyeonggido
ZIP/Postal Code
420-767
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
156-755
Country
Korea, Republic of
City
Bialystok
ZIP/Postal Code
15-540
Country
Poland
City
Malbork
ZIP/Postal Code
82-200
Country
Poland
City
Poznan
ZIP/Postal Code
61-858
Country
Poland
City
Radom
ZIP/Postal Code
26-610
Country
Poland
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
City
Zyrardow
ZIP/Postal Code
96-300
Country
Poland
City
Bucharest
ZIP/Postal Code
020475
Country
Romania
City
Constanta
ZIP/Postal Code
900591
Country
Romania
City
Oradea
ZIP/Postal Code
410469
Country
Romania
City
Targu-Mures
ZIP/Postal Code
540103
Country
Romania
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Ankara Univ. Medical Faculty
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Baskent University Medical Faculty
City
Ankara
ZIP/Postal Code
06490
Country
Turkey
Facility Name
Sifa University Medical Faculty
City
Izmir
ZIP/Postal Code
03540
Country
Turkey
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
City
Doncaster
State/Province
South Yorkshire
ZIP/Postal Code
DN2 5LT
Country
United Kingdom
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
36005278
Citation
Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
Results Reference
derived
Links:
URL
https://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer products
Learn more about this trial
15141 Fixed Dose Correction / naïve and Pre Dialysis (Europe and Asia Pacific)
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