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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02021370




Registration number
NCT02021370
Ethics application status
Date submitted
20/12/2013
Date registered
27/12/2013
Date last updated
20/09/2019

Titles & IDs
Public title
15141 Fixed Dose Correction / naïve and Pre Dialysis (Europe and Asia Pacific)
Scientific 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
Secondary ID [1] 0 0
2013-001193-14
Secondary ID [2] 0 0
15141
Universal Trial Number (UTN)
Trial acronym
DIALOGUE 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anemia 0 0
Renal Insufficiency, Chronic 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Blood 0 0 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BAY85-3934
Treatment: Drugs - Placebo

Experimental: BAY85-3934 (25mg OD) - 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

Experimental: BAY85-3934 (50mg OD) - 50 mg OD of BAY85-3934 Morning: 2 tablets BAY85-3934 25 mg and 1 tablet matching placebo Evening: 3 tablets matching placebo

Experimental: BAY85-3934 (75mg OD) - 75 mg OD of BAY85-3934 Morning: 3 tablets BAY85-3934 25 mg Evening: 3 tablets matching placebo

Experimental: BAY85-3934 (25mg BID) - 25 mg twice daily (BID) of BAY85-3934 Morning and evening: 1 tablet BAY85-3934 25 mg and 2 tablets matching placebo

Experimental: BAY85-3934 (50mg BID) - 50 mg BID of BAY85-3934 Morning and evening: 2 tablets BAY85-3934 25 mg and 1 tablet matching placebo

Placebo Comparator: Placebo BID - Placebo BID Morning and evening: 3 tablets of placebo matching BAY85-3934 25 mg


Treatment: Drugs: BAY85-3934
25mg Tablet

Treatment: Drugs: Placebo
Matching placebo tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period
Timepoint [1] 0 0
Baseline and week 12 to 16
Secondary outcome [1] 0 0
Change in local laboratory hemoglobin level from baseline
Timepoint [1] 0 0
Baseline up to 12 weeks
Secondary outcome [2] 0 0
Speed of change in hemoglobin level per unit time
Timepoint [2] 0 0
Up to 16 weeks
Secondary outcome [3] 0 0
Duration of treatment exposure
Timepoint [3] 0 0
Up to 16 weeks
Secondary outcome [4] 0 0
Number of participants with serious adverse events as a measure of safety and tolerability
Timepoint [4] 0 0
Up to 16 weeks
Secondary outcome [5] 0 0
Pharmacodynamics characterized by erythropoietin concentration
Timepoint [5] 0 0
Several time points up to 16 weeks
Secondary outcome [6] 0 0
Pharmacodynamics characterized by reticulocyte count
Timepoint [6] 0 0
Several time points up to 16 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/09/2015
Sample size
Target
Accrual to date
Final
121
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
- Gosford
Recruitment hospital [2] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
3052 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Bulgaria
State/province [1] 0 0
Gabrovo
Country [2] 0 0
Bulgaria
State/province [2] 0 0
Lovech
Country [3] 0 0
Bulgaria
State/province [3] 0 0
Montana
Country [4] 0 0
Bulgaria
State/province [4] 0 0
Pazardjik
Country [5] 0 0
Bulgaria
State/province [5] 0 0
Stara Zagora
Country [6] 0 0
Bulgaria
State/province [6] 0 0
Veliko Tarnovo
Country [7] 0 0
France
State/province [7] 0 0
Limoges Cedex1
Country [8] 0 0
Germany
State/province [8] 0 0
Baden-Württemberg
Country [9] 0 0
Germany
State/province [9] 0 0
Nordrhein-Westfalen
Country [10] 0 0
Germany
State/province [10] 0 0
Sachsen-Anhalt
Country [11] 0 0
Hungary
State/province [11] 0 0
Baja
Country [12] 0 0
Hungary
State/province [12] 0 0
Budapest
Country [13] 0 0
Hungary
State/province [13] 0 0
Pecs
Country [14] 0 0
Israel
State/province [14] 0 0
Ashkelon
Country [15] 0 0
Israel
State/province [15] 0 0
Hadera
Country [16] 0 0
Israel
State/province [16] 0 0
Nahariya
Country [17] 0 0
Italy
State/province [17] 0 0
Campania
Country [18] 0 0
Italy
State/province [18] 0 0
Emilia-Romagna
Country [19] 0 0
Italy
State/province [19] 0 0
Lombardia
Country [20] 0 0
Italy
State/province [20] 0 0
Toscana
Country [21] 0 0
Japan
State/province [21] 0 0
Fukuoka
Country [22] 0 0
Japan
State/province [22] 0 0
Hokkaido
Country [23] 0 0
Japan
State/province [23] 0 0
Ishikawa
Country [24] 0 0
Japan
State/province [24] 0 0
Iwate
Country [25] 0 0
Japan
State/province [25] 0 0
Kanagawa
Country [26] 0 0
Japan
State/province [26] 0 0
Mie
Country [27] 0 0
Japan
State/province [27] 0 0
Chiba
Country [28] 0 0
Japan
State/province [28] 0 0
Nara
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Gyeonggido
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Seoul
Country [31] 0 0
Poland
State/province [31] 0 0
Bialystok
Country [32] 0 0
Poland
State/province [32] 0 0
Malbork
Country [33] 0 0
Poland
State/province [33] 0 0
Poznan
Country [34] 0 0
Poland
State/province [34] 0 0
Radom
Country [35] 0 0
Poland
State/province [35] 0 0
Szczecin
Country [36] 0 0
Poland
State/province [36] 0 0
Zyrardow
Country [37] 0 0
Romania
State/province [37] 0 0
Bucharest
Country [38] 0 0
Romania
State/province [38] 0 0
Constanta
Country [39] 0 0
Romania
State/province [39] 0 0
Oradea
Country [40] 0 0
Romania
State/province [40] 0 0
Targu-Mures
Country [41] 0 0
Spain
State/province [41] 0 0
A Coruña
Country [42] 0 0
Spain
State/province [42] 0 0
Barcelona
Country [43] 0 0
Turkey
State/province [43] 0 0
Ankara
Country [44] 0 0
Turkey
State/province [44] 0 0
Izmir
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Cambridgeshire
Country [46] 0 0
United Kingdom
State/province [46] 0 0
South Yorkshire
Country [47] 0 0
United Kingdom
State/province [47] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02021370
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries