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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/NCT02021409




Registration number
NCT02021409
Ethics application status
Date submitted
20/12/2013
Date registered
27/12/2013
Date last updated
19/09/2019

Titles & IDs
Public title
Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment Versus BAY85-3934
Scientific title
A Randomized, Parallel Group, Open-label, Multicenter Study to Investigate the Efficacy and Safety of Oral BAY85-3934 and Active Comparator (Darbepoetin Alfa) in the Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment in Europe and Asia Pacific
Secondary ID [1] 0 0
2013-001192-21
Secondary ID [2] 0 0
15261
Universal Trial Number (UTN)
Trial acronym
DIALOGUE 2
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
Other interventions - Darbepoetin alfa

Experimental: BAY85-3934 (25mg) - Fixed starting dose of 25 mg of BAY85-3934 oral tablet (once daily dose) titrated at the scheduled dose control visits. Titration occuring every 4-weeks will be based on the subject's hemoglobin (Hb) response and tolerability of the prior dose. Total treatment time is 16 weeks. Planned doses include 15, 25, 50, 75, 100, and 150 mg once daily.

Experimental: BAY85-3934 (50mg) - Fixed starting dose of 50 mg of BAY85-3934 oral tablet (once daily dose) titrated at the scheduled dose control visits. Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose. Total treatment time is 16 weeks. Planned doses include 15, 25, 50, 75, 100, and 150 mg once daily.

Experimental: BAY85-3934 (75mg) - Fixed starting doses of 75 mg of BAY85-3934 oral tablet (once daily dose) titrated at the scheduled dose control visits. Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose. Total treatment time is 16 weeks. Planned doses include 15, 25, 50, 75, 100, and 150 mg once daily.

Active Comparator: Darbepoetin alfa - Darbepoetin (intravenous or subcutaneous) will be administered according to the local label and titrated at the scheduled dose control visits. Titration will be based on the subject's Hb response and tolerability of the prior dose.


Treatment: Drugs: BAY85-3934
Oral doses of BAY 85-3934 will be available in multiples of 5, 25, and 75 mg tablets

Other interventions: Darbepoetin alfa
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
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
Maintenance in hemoglobin target range (10.0 to 12.0 g/dL)
Timepoint [1] 0 0
Up to 16 weeks
Secondary outcome [2] 0 0
Change in hemoglobin level
Timepoint [2] 0 0
Baseline up to 16 weeks
Secondary outcome [3] 0 0
Number of patients with hemoglobin levels outside the target range
Timepoint [3] 0 0
Week 12 to 16
Secondary outcome [4] 0 0
Dose level in the evaluation period
Timepoint [4] 0 0
Week 12 to 16
Secondary outcome [5] 0 0
Duration of exposure on each dose level
Timepoint [5] 0 0
Up to 16 weeks
Secondary outcome [6] 0 0
Number of subjects requiring titration of dose
Timepoint [6] 0 0
Up to 16 weeks
Secondary outcome [7] 0 0
Number of participants with serious adverse events as a measure of safety and tolerability
Timepoint [7] 0 0
Up to 16 weeks

Eligibility
Key inclusion criteria
- Male or female subjects = 18 years of age with anemia of chronic kidney disease (CKD)
at screening

- Estimated glomerular filtration rate (eGFR) of < 60 mL/min/1.73 m2 (Modification of
Diet in Renal Disease 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)

- Treated with darbepoetin via intravenous (IV) or subcutaneous (SC) route with a
weekly, bi-weekly, or monthly dose, having had no more than one dose change within 8
weeks prior to randomization

- At least one kidney

- Mean screening hemoglobin (Hb) concentration of 10.0 to 12.0 g/dL

- Men who agree to use adequate contraception when sexually active or women without
childbearing potential
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

- Active hemolysis or diagnosis of hemolytic syndrome

- History of myelodysplastic syndrome, multiple myeloma, marrow fibrosis, or pure
red-cell aplasia (PRCA)

- History of hemosiderosis or hemochromatosis

- Hereditary hemoglobinopathies (such as sickle cell disease and thalassemia major)

- Aplastic anemia

- Chronic lymphoproliferative diseases

- Proliferative choroidal or retinal disease, such as neovascular age-related macular
degeneration or proliferative diabetic retinopathy that is likely to require invasive
treatment (intraocular injections or laser photocoagulation) during the study

- Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus
erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in
remission

- Known hypersensitivity to the study drugs (active substances or excipients of the
preparations)

- Uncontrolled and symptomatic hyperparathyroidism

- Uncontrolled active infection

- 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

- Any allograft (including renal allograft) in place and on immunosuppressive therapy or
a scheduled kidney transplant within the next 16 weeks (being on a waiting list does
not exclude the subject)

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
Open (masking not used)
Who is / are masked / blinded?



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
28/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/11/2015
Sample size
Target
Accrual to date
Final
126
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
- Gosford
Recruitment hospital [2] 0 0
- Reservoir
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
3073 - Reservoir
Recruitment outside Australia
Country [1] 0 0
Bulgaria
State/province [1] 0 0
Dobrich
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
Sofia
Country [6] 0 0
Bulgaria
State/province [6] 0 0
Stara Zagora
Country [7] 0 0
France
State/province [7] 0 0
Grenoble Cedex 9
Country [8] 0 0
France
State/province [8] 0 0
Pierre Benite Cedex
Country [9] 0 0
Germany
State/province [9] 0 0
Nordrhein-Westfalen
Country [10] 0 0
Hungary
State/province [10] 0 0
Baja
Country [11] 0 0
Hungary
State/province [11] 0 0
Budapest
Country [12] 0 0
Hungary
State/province [12] 0 0
Esztergom
Country [13] 0 0
Hungary
State/province [13] 0 0
Kaposvar
Country [14] 0 0
Hungary
State/province [14] 0 0
Pecs
Country [15] 0 0
Hungary
State/province [15] 0 0
Szigetvar
Country [16] 0 0
Israel
State/province [16] 0 0
Ashkelon
Country [17] 0 0
Israel
State/province [17] 0 0
Hadera
Country [18] 0 0
Israel
State/province [18] 0 0
Kfar Saba
Country [19] 0 0
Israel
State/province [19] 0 0
Nahariya
Country [20] 0 0
Italy
State/province [20] 0 0
Campania
Country [21] 0 0
Italy
State/province [21] 0 0
Lombardia
Country [22] 0 0
Italy
State/province [22] 0 0
Toscana
Country [23] 0 0
Japan
State/province [23] 0 0
Fukuoka
Country [24] 0 0
Japan
State/province [24] 0 0
Hokkaido
Country [25] 0 0
Japan
State/province [25] 0 0
Iwate
Country [26] 0 0
Japan
State/province [26] 0 0
Kanagawa
Country [27] 0 0
Japan
State/province [27] 0 0
Mie
Country [28] 0 0
Japan
State/province [28] 0 0
Chiba
Country [29] 0 0
Japan
State/province [29] 0 0
Nagano
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Gyeonggido
Country [31] 0 0
Poland
State/province [31] 0 0
Bialystok
Country [32] 0 0
Poland
State/province [32] 0 0
Radom
Country [33] 0 0
Romania
State/province [33] 0 0
Bucharest
Country [34] 0 0
Romania
State/province [34] 0 0
Oradea
Country [35] 0 0
Romania
State/province [35] 0 0
Targu-Mures
Country [36] 0 0
Spain
State/province [36] 0 0
Barcelona
Country [37] 0 0
Spain
State/province [37] 0 0
Madrid
Country [38] 0 0
Turkey
State/province [38] 0 0
Ankara
Country [39] 0 0
Turkey
State/province [39] 0 0
Izmir
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Cambridgeshire
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Liverpool

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 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02021409
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02021409