AnemiaPhase 2DIALOGUE 1NCT02021370
15141 Fixed Dose Correction / naïve and Pre Dialysis (Europe and Asia Pacific)
A Phase 2 study testing BAY85-3934 in people with Anemia and Renal Insufficiency, Chronic, run by Bayer at 56 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 56 sitesin 14 countries
- Study dates
- 10 Feb 2014to 23 Sep 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
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
56 sites in 14 countries.
56 sites in 14 countries
Japan10 sites
Study site
Chiba, 260-8712
Study site
Fukuoka, 810-8563
Study site
Hakusan, Ishikawa-ken, 924-8588
Study site
Kamakura, Kanagawa, 247-8533
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
Nara, 630-8581
Study site
Ōkawa, Fukuoka, 831-0016
Bulgaria6 sites
Study site
Gabrovo, 5300
Study site
Lovech, 5500
Study site
Montana, 3400
Study site
Pazardzhik, 4400
Study site
Stara Zagora, 6000
Study site
Veliko Tarnovo, 5000
Poland6 sites
Study site
Bialystok, 15-540
Study site
Malbork, 82-200
Study site
Poznan, 61-858
Study site
Radom, 26-610
Study site
Szczecin, 70-111
Study site
Żyrardów, 96-300
Italy5 sites
Study site
Cremona, Lombardy, 26100
Study site
Livorno, Tuscany, 57023
Study site
Modena, Emilia-Romagna, 41100
Study site
Naples, Campania, 80138
Study site
Pavia, Lombardy, 27100
Germany4 sites
Study site
Bonn, North Rhine-Westphalia, 53127
Study site
Düsseldorf, North Rhine-Westphalia, 40210
Study site
Halle, Saxony-Anhalt, 06097
Study site
Villingen-Schwenningen, Baden-Wurttemberg, 78052
Romania4 sites
Study site
Bucharest, 020475
Study site
Constanța, 900591
Study site
Oradea, 410469
Study site
Târgu Mureş, 540103
South Korea4 sites
Study site
Bucheon-si, Gyeonggido, 420-767
Study site
Seoul, 03080
Study site
Seoul, 156-707
Study site
Seoul, 156-755
Hungary3 sites
Study site
Baja, 6500
Study site
Budapest, 1036
Study site
Pécs, 7623
Israel3 sites
Study site
Ashkelon, 7827804
Study site
Hadera, 3810101
Study site
Nahariya, 2210001
Turkey (Türkiye)3 sites
Ankara Univ. Medical Faculty
Ankara, 06100
Baskent University Medical Faculty
Ankara, 06490
Sifa University Medical Faculty
Izmir, 03540
United Kingdom3 sites
Study site
Cambridge, Cambridgeshire, CB2 0QQ
Study site
Doncaster, South Yorkshire, DN2 5LT
Study site
London, SE5 9RS
Australia2 sites
Study site
Gosford, New South Wales, 2250
Study site
Melbourne, Victoria, 3052
Spain2 sites
Study site
L'Hospitalet de Llobregat, Barcelona, 08907
Study site
Santiago de Compostela, A Coruña, 15706
About this study
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
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 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.
- Conditions
- Anemia, Renal Insufficiency, Chronic
- Being tested
- BAY85-3934, Placebo
- Keywords
- Anemia of 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
25mg Tablet
PlaceboDrug
Matching placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| BAY85-3934 (25mg OD) | Experimental | 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 Receives: Drug: BAY85-3934; Drug: Placebo |
| BAY85-3934 (50mg OD) | Experimental | 50 mg OD of BAY85-3934 Morning: 2 tablets BAY85-3934 25 mg and 1 tablet matching placebo Evening: 3 tablets matching placebo Receives: Drug: BAY85-3934; Drug: Placebo |
| BAY85-3934 (75mg OD) | Experimental | 75 mg OD of BAY85-3934 Morning: 3 tablets BAY85-3934 25 mg Evening: 3 tablets matching placebo Receives: Drug: BAY85-3934; Drug: Placebo |
| BAY85-3934 (25mg BID) | Experimental | 25 mg twice daily (BID) of BAY85-3934 Morning and evening: 1 tablet BAY85-3934 25 mg and 2 tablets matching placebo Receives: Drug: BAY85-3934; Drug: Placebo |
| BAY85-3934 (50mg BID) | Experimental | 50 mg BID of BAY85-3934 Morning and evening: 2 tablets BAY85-3934 25 mg and 1 tablet matching placebo Receives: Drug: BAY85-3934; Drug: Placebo |
| Placebo BID | Placebo comparator | Placebo BID Morning and evening: 3 tablets of placebo matching BAY85-3934 25 mg Receives: Drug: Placebo |
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 (6)
Change in local laboratory hemoglobin level from baseline
Measured: Baseline up to 12 weeks
Speed of change in hemoglobin level per unit time
Measured: Up to 16 weeks
Duration of treatment exposure
Measured: Up to 16 weeks
Number of participants with serious adverse events as a measure of safety and tolerability
Measured: Up to 16 weeks
Pharmacodynamics characterized by erythropoietin concentration
Measured: Several time points up to 16 weeks
Pharmacodynamics characterized by reticulocyte count
Measured: Several time points 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 start10 Feb 2014
- Primary completion15 Sep 2015
- Study completion23 Sep 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 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
- NCT02021370
- Sponsor's protocol ID
- 15141
- Other IDs
- 2013-001193-14
- Acronym
- DIALOGUE 1
- Status last verified
- Sep 2019
- First submitted
- 20 Dec 2013
- Last updated
- 20 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 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02021370
- Acronym / sponsor ID
- DIALOGUE 1 / 15141
- Conditions
- Anemia, Renal Insufficiency, Chronic
- Keywords
- Anemia of CKD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2014 (actual)
- Primary completion
- 15 Sep 2015 (actual)
- Study completion
- 23 Sep 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| BAY85-3934 (25mg OD) | Experimental | Drug: BAY85-3934, Drug: Placebo25 mg once daily (OD) of BAY85-3934 Morning: 1 tablet BAY85-3934 25 mg and 2 tablets matching placebo Evening: 3 tablets matching placebo |
| BAY85-3934 (50mg OD) | Experimental | Drug: BAY85-3934, Drug: Placebo50 mg OD of BAY85-3934 Morning: 2 tablets BAY85-3934 25 mg and 1 tablet matching placebo Evening: 3 tablets matching placebo |
| BAY85-3934 (75mg OD) | Experimental | Drug: BAY85-3934, Drug: Placebo75 mg OD of BAY85-3934 Morning: 3 tablets BAY85-3934 25 mg Evening: 3 tablets matching placebo |
| BAY85-3934 (25mg BID) | Experimental | Drug: BAY85-3934, Drug: Placebo25 mg twice daily (BID) of BAY85-3934 Morning and evening: 1 tablet BAY85-3934 25 mg and 2 tablets matching placebo |
| BAY85-3934 (50mg BID) | Experimental | Drug: BAY85-3934, Drug: Placebo50 mg BID of BAY85-3934 Morning and evening: 2 tablets BAY85-3934 25 mg and 1 tablet matching placebo |
| Placebo BID | Placebo comparator | Drug: PlaceboPlacebo BID Morning and evening: 3 tablets of placebo matching BAY85-3934 25 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| BAY85-393425mg Tablet | Drug | BAY85-3934 (25mg BID), BAY85-3934 (25mg OD), BAY85-3934 (50mg BID), BAY85-3934 (50mg OD), BAY85-3934 (75mg OD) |
| PlaceboMatching placebo tablet | Drug | BAY85-3934 (25mg BID), BAY85-3934 (25mg OD), BAY85-3934 (50mg BID), BAY85-3934 (50mg OD), BAY85-3934 (75mg OD), Placebo BID |
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
6 secondary outcomes
Change in local laboratory hemoglobin level from baseline
Time frame: Baseline up to 12 weeks
Speed of change in hemoglobin level per unit time
Time frame: Up to 16 weeks
Duration of treatment exposure
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
Pharmacodynamics characterized by erythropoietin concentration
Time frame: Several time points up to 16 weeks
Pharmacodynamics characterized by reticulocyte count
Time frame: Several time points 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 20 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.
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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
56 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 in people with Anemia and Renal Insufficiency, Chronic, run by Bayer at 56 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 9 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 20 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 56 sites in Japan, Bulgaria, Poland, Italy, Germany 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. Some participants in this study may receive a placebo. 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 NCT02021370, 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 20 Sep 2019.