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Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment Versus BAY85-3934 (DIALOGUE 2)

Primary Purpose

Anemia, Renal Insufficiency, Chronic

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BAY85-3934
Darbepoetin alfa
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Anemia on CKD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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)

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 Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

BAY85-3934 (25mg)

BAY85-3934 (50mg)

BAY85-3934 (75mg)

Darbepoetin alfa

Arm Description

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.

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.

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.

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.

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

Maintenance in hemoglobin target range (10.0 to 12.0 g/dL)
Change in hemoglobin level
Number of patients with hemoglobin levels outside the target range
Dose level in the evaluation period
Duration of exposure on each dose level
Number of subjects requiring titration of dose
Number of participants with serious adverse events as a measure of safety and tolerability

Full Information

First Posted
December 20, 2013
Last Updated
September 17, 2019
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT02021409
Brief Title
Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment Versus BAY85-3934
Acronym
DIALOGUE 2
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 28, 2014 (Actual)
Primary Completion Date
October 15, 2015 (Actual)
Study Completion Date
November 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 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.

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 on CKD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BAY85-3934 (25mg)
Arm Type
Experimental
Arm Description
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.
Arm Title
BAY85-3934 (50mg)
Arm Type
Experimental
Arm Description
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.
Arm Title
BAY85-3934 (75mg)
Arm Type
Experimental
Arm Description
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.
Arm Title
Darbepoetin alfa
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
BAY85-3934
Intervention Description
Oral doses of BAY 85-3934 will be available in multiples of 5, 25, and 75 mg tablets
Intervention Type
Biological
Intervention Name(s)
Darbepoetin alfa
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
Maintenance in hemoglobin target range (10.0 to 12.0 g/dL)
Time Frame
Up to 16 weeks
Title
Change in hemoglobin level
Time Frame
Baseline up to 16 weeks
Title
Number of patients with hemoglobin levels outside the target range
Time Frame
Week 12 to 16
Title
Dose level in the evaluation period
Time Frame
Week 12 to 16
Title
Duration of exposure on each dose level
Time Frame
Up to 16 weeks
Title
Number of subjects requiring titration of dose
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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)
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
Reservoir
State/Province
Victoria
ZIP/Postal Code
3073
Country
Australia
City
Dobrich
ZIP/Postal Code
9300
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
Sofia
ZIP/Postal Code
1872
Country
Bulgaria
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
City
Grenoble Cedex 9
ZIP/Postal Code
38043
Country
France
City
Pierre Benite Cedex
ZIP/Postal Code
69495
Country
France
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53127
Country
Germany
City
Baja
ZIP/Postal Code
6500
Country
Hungary
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
City
Esztergom
ZIP/Postal Code
2500
Country
Hungary
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
City
Szigetvar
ZIP/Postal Code
7900
Country
Hungary
City
Ashkelon
ZIP/Postal Code
7827804
Country
Israel
City
Hadera
ZIP/Postal Code
3810101
Country
Israel
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
City
Nahariya
ZIP/Postal Code
2210001
Country
Israel
City
Napoli
State/Province
Campania
ZIP/Postal Code
80138
Country
Italy
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
City
Cremona
State/Province
Lombardia
ZIP/Postal Code
26100
Country
Italy
City
Lecco
State/Province
Lombardia
ZIP/Postal Code
23900
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
Morioka
State/Province
Iwate
ZIP/Postal Code
020-0066
Country
Japan
City
Fujisawa
State/Province
Kanagawa
ZIP/Postal Code
251-8550
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
Nagano
ZIP/Postal Code
388-8004
Country
Japan
City
Bucheon-si
State/Province
Gyeonggido
ZIP/Postal Code
420-767
Country
Korea, Republic of
City
Bialystok
ZIP/Postal Code
15-540
Country
Poland
City
Radom
ZIP/Postal Code
26-610
Country
Poland
City
Bucharest
ZIP/Postal Code
010731
Country
Romania
City
Bucharest
ZIP/Postal Code
020475
Country
Romania
City
Oradea
ZIP/Postal Code
410469
Country
Romania
City
Targu-Mures
ZIP/Postal Code
540103
Country
Romania
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
City
San Sebastián de los Reyes
State/Province
Madrid
ZIP/Postal Code
28702
Country
Spain
City
Madrid
ZIP/Postal Code
28007
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
Liverpool
ZIP/Postal Code
L7 8XP
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://www.clinicaltrialsregister.eu/
Description
Click here and search for results provided by EudraCT
URL
http://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer products

Learn more about this trial

Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment Versus BAY85-3934

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