AnemiaPhase 2DIALOGUE 2NCT02021409
Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment Versus BAY85-3934
A Phase 2 study testing BAY85-3934 and Darbepoetin alfa in people with Anemia and Renal Insufficiency, Chronic, run by Bayer at 51 sites in 14 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Renal Insufficiency, Chronic
- What is being tested?
- BAY85-3934 and Darbepoetin alfa
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 51 sitesin 14 countries
- Study dates
- 28 Jan 2014to 23 Nov 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
51 sites in 14 countries.
51 sites in 14 countries
Japan9 sites
Study site
Chiba, 260-8712
Study site
Fujisawa, Kanagawa, 251-8550
Study site
Fukuoka, 810-8563
Study site
Kitakyushu, Fukuoka, 802-8555
Study site
Kuwana, Mie-ken, 511-0061
Study site
Morioka, Iwate, 020-0066
Study site
Muroran, Hokkaido, 050-0083
Study site
Nagano, 388-8004
Study site
Ōkawa, Fukuoka, 831-0016
Bulgaria6 sites
Study site
Dobrich, 9300
Study site
Lovech, 5500
Study site
Montana, 3400
Study site
Pazardzhik, 4400
Study site
Sofia, 1872
Study site
Stara Zagora, 6000
Hungary6 sites
Study site
Baja, 6500
Study site
Budapest, 1036
Study site
Esztergom, 2500
Study site
Kaposvár, 7400
Study site
Pécs, 7624
Study site
Szigetvár, 7900
Italy6 sites
Study site
Brescia, Lombardy, 25123
Study site
Cremona, Lombardy, 26100
Study site
Lecco, Lombardy, 23900
Study site
Livorno, Tuscany, 57023
Study site
Naples, Campania, 80138
Study site
Pavia, Lombardy, 27100
Israel4 sites
Study site
Ashkelon, 7827804
Study site
Hadera, 3810101
Study site
Kfar Saba, 4428164
Study site
Nahariya, 2210001
Romania4 sites
Study site
Bucharest, 010731
Study site
Bucharest, 020475
Study site
Oradea, 410469
Study site
Târgu Mureş, 540103
Spain3 sites
Study site
L'Hospitalet de Llobregat, Barcelona, 08907
Study site
Madrid, 28007
Study site
San Sebastián de los Reyes, Madrid, 28702
Turkey (Türkiye)3 sites
Ankara Univ. Medical Faculty
Ankara, 06100
Baskent University Medical Faculty
Ankara, 06490
Sifa University Medical Faculty
Izmir, 03540
Australia2 sites
Study site
Gosford, New South Wales, 2250
Study site
Reservoir, Victoria, 3073
United Kingdom2 sites
Study site
Cambridge, Cambridgeshire, CB2 0QQ
Study site
Liverpool, L7 8XP
About this study
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
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.
Read more
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.
- Conditions
- Anemia, Renal Insufficiency, Chronic
- Being tested
- BAY85-3934, Darbepoetin alfa
- Keywords
- Anemia on CKD
- Medical subject headings
- Anemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY85-3934Drug
Oral doses of BAY 85-3934 will be available in multiples of 5, 25, and 75 mg tablets
Darbepoetin alfaBiological
| Study group | Role | What they receive |
|---|---|---|
| BAY85-3934 (25mg) | Experimental | 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. Receives: Drug: BAY85-3934 |
| BAY85-3934 (50mg) | Experimental | 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. Receives: Drug: BAY85-3934 |
| BAY85-3934 (75mg) | Experimental | 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. Receives: Drug: BAY85-3934 |
| Darbepoetin alfa | Active comparator | 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. Receives: Biological: Darbepoetin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period
Measured: Baseline and week 12 to 16
Secondary outcomes (7)
Maintenance in hemoglobin target range (10.0 to 12.0 g/dL)
Measured: Up to 16 weeks
Change in hemoglobin level
Measured: Baseline up to 16 weeks
Number of patients with hemoglobin levels outside the target range
Measured: Week 12 to 16
Dose level in the evaluation period
Measured: Week 12 to 16
Duration of exposure on each dose level
Measured: Up to 16 weeks
Number of subjects requiring titration of dose
Measured: Up to 16 weeks
Number of participants with serious adverse events as a measure of safety and tolerability
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study start28 Jan 2014
- Primary completion15 Oct 2015
- Study completion23 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021409
- Sponsor's protocol ID
- 15261
- Other IDs
- 2013-001192-21
- Acronym
- DIALOGUE 2
- Status last verified
- Sep 2019
- First submitted
- 20 Dec 2013
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 36005278
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02021409
- Acronym / sponsor ID
- DIALOGUE 2 / 15261
- Conditions
- Anemia, Renal Insufficiency, Chronic
- Keywords
- Anemia on CKD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2014 (actual)
- Primary completion
- 15 Oct 2015 (actual)
- Study completion
- 23 Nov 2015 (actual)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BAY85-3934 (25mg) | Experimental | Drug: BAY85-3934Fixed 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. |
| BAY85-3934 (50mg) | Experimental | Drug: BAY85-3934Fixed 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. |
| BAY85-3934 (75mg) | Experimental | Drug: BAY85-3934Fixed 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 alfa | Active comparator | Biological: Darbepoetin alfaDarbepoetin (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAY85-3934Oral doses of BAY 85-3934 will be available in multiples of 5, 25, and 75 mg tablets | Drug | BAY85-3934 (25mg), BAY85-3934 (50mg), BAY85-3934 (75mg) |
| Darbepoetin alfa | Biological | Darbepoetin alfa |
Primary outcome
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
7 secondary outcomes
Maintenance in hemoglobin target range (10.0 to 12.0 g/dL)
Time frame: Up to 16 weeks
Change in hemoglobin level
Time frame: Baseline up to 16 weeks
Number of patients with hemoglobin levels outside the target range
Time frame: Week 12 to 16
Dose level in the evaluation period
Time frame: Week 12 to 16
Duration of exposure on each dose level
Time frame: Up to 16 weeks
Number of subjects requiring titration of dose
Time frame: Up to 16 weeks
Number of participants with serious adverse events as a measure of safety and tolerability
Time frame: Up to 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Derived from this study: PubMed 36005278Natale 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.
- Click here and search for results provided by EudraCTLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
51 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BAY85-3934 and Darbepoetin alfa in people with Anemia and Renal Insufficiency, Chronic, run by Bayer at 51 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in Japan, Bulgaria, Hungary, Italy, Israel and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02021409, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.