AnemiaPhase 2DIALOGUE 3NCT02055482
Long-term Pre-dialysis Extension in Europe and Asia Pacific
A Phase 2 study testing Molidustat (BAY85-3934) and Darbepoetin in people with Anemia and Renal Insufficiency, Chronic, run by Bayer at 105 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?
- Molidustat (BAY85-3934) and Darbepoetin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 105 sitesin 14 countries
- Study dates
- 24 Jun 2014to 12 Dec 2016
- 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
- Men who agree to use adequate contraception when sexually active or women without childbearing potential
- Not on dialysis at study entry
- Serum ferritin levels ≥ 100 μg/L and < 1000 μg/L or transferrin saturation ≥ 20%
- Inclusion criteria for inclusion into the Hb Stabilization (HbS) Phase: Requires Hb stabilization (at 10.0 to 12..0g/dL for a minimum of 4 weeks) as follows: Received BAY 85-3934 and reached a stopping event in Study 15141 or received placebo and reached a stopping event in Study 15141 or completed 16 weeks of treatment with BAY 85-3934 in Study 15141or 15261 but had mean Hb during the evaluation period outside the target range of 10.0 to 12.0 g/dL, or Completed 16 weeks of treatment with placebo in Study 15141 and was re-assessed at 4 weeks after end of study as eligible for Study 15653 (this study)
- Inclusion criteria for inclusion into the Main Phase: Mean Hb concentration of 10.0 to 12.0 g/dL who completed 16 weeks of treatment (BAY85-3934 arm) in Study 15141, or completed 16 weeks of treatment (BAY-3934 or darbepoetin arm)in study 15261 without a dose suspension lasting > 6 consecutive weeks, or mean Hb concentration of 10.0 to 12.0g/dL during the HbS phase of Study 15653 for a minimum of 4 weeks after visit 3.
Who cannot join
- A scheduled kidney transplant or any other organ transplant within the next 6 months (being on a waiting list does not exclude the subject)
- Red blood cell (RBC) containing transfusion within the 8 weeks before baseline
- Phosphodiesterase type 5 (PDE5) inhibitor (e.g., sildenafil, vardenafil, tadalafil) or nitrates
- Sustained, poorly controlled arterial hypertension or hypotension at baseline, defined as blood pressure ≥ 180/110 mmHg or systolic blood pressure < 95 mmHg, respectively
- Severe rhythm or conduction disorders (e.g., heart rate [HR] < 50 or > 110 bpm, atrial flutter, prolonged QT > 500 msec, second or third degree atrioventricular [AV] block), if not reacted with a pace marker)
- New York Heart Association Class III or IV congestive heart failure
- Severe hepatic insufficiency (defined as alanine aminotransferase [ALT], aspartate aminotransferase [AST]>3x the upper limit of normal [ULN], total bilirubin > 2 mg/dL, or Child Pugh B or C) or active hepatitis, in the investigator's opinion
- An ongoing serious adverse event (SAE) from Study 15141 or Study 15261 that is assessed as related to study drug
Trial locations and contacts
105 sites in 14 countries.
105 sites in 14 countries
United Kingdom15 sites
Study site
Brighton, East Sussex, BN2 5BE
Study site
Cambridge, Cambridgeshire, CB2 0QQ
Study site
Chorley, PR7 7NA
Study site
Doncaster, South Yorkshire, DN2 5LT
Study site
Dundee, Dundee City, DD1 9SY
Study site
Glasgow, G20 OSP
Study site
Hexham, Northumberland, NE46 1QJ
Study site
Leeds, West Yorkshire, WF3 4PX
Study site
Liverpool, L22 0LG
Study site
Liverpool, L7 8XP
Study site
London, SE5 9RS
Study site
London
Study site
Manchester, M15 6SX
Study site
Reading, Berkshire, RG2 0TG
Study site
Salford, Manchester, M5 5AP
Bulgaria13 sites
Study site
Burgas, 8000
Study site
Dobrich, 9300
Study site
Gabrovo, 5300
Study site
Karlovo, 4300
Study site
Lovech, 5500
Study site
Montana, 3400
Study site
Pazardzhik, 4400
Study site
Sofia, 1309
Study site
Sofia, 1431
Study site
Sofia, 1527
Study site
Sofia, 1872
Study site
Stara Zagora, 6000
Study site
Veliko Tarnovo, 5000
Japan12 sites
Study site
Chiba, 260-8712
Study site
Fujisawa, Kanagawa, 251-8550
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
Nagano, 388-8004
Study site
Nara, 631-0846
Study site
Ōkawa, Fukuoka, 831-0016
Italy10 sites
Study site
Brescia, Lombardy, 25123
Study site
Chieti, Abruzzo, 66013
Study site
Cremona, Lombardy, 26100
Study site
Lecco, Lombardy, 23900
Study site
Livorno, Tuscany, 57023
Study site
Milan, Lombardy, 20132
Study site
Milan, Lombardy, 20162
Study site
Modena, Emilia-Romagna, 41100
Study site
Naples, Campania, 80138
Study site
Pavia, Lombardy, 27100
Spain9 sites
Study site
Alicante, 03010
Study site
Barcelona, 08035
Study site
Barcelona, 08036
Study site
Córdoba, 14004
Study site
L'Hospitalet de Llobregat, Barcelona, 08907
Study site
Madrid, 28007
Study site
Madrid, 28041
Study site
San Sebastián de los Reyes, Madrid, 28702
Study site
Santiago de Compostela, A Coruña, 15706
Germany7 sites
Study site
Berlin, 12053
Study site
Bonn, North Rhine-Westphalia, 53127
Study site
Düsseldorf, North Rhine-Westphalia, 40210
Study site
Halle, Saxony-Anhalt, 06097
Study site
Pirmasens, Baden-Wurttemberg, 66953
Study site
Villingen-Schwenningen, Baden-Wurttemberg, 78052
Study site
Wuppertal, 42283
Hungary7 sites
Study site
Baja, 6500
Study site
Budapest, 1036
Study site
Debrecen, 4032
Study site
Esztergom, 2500
Study site
Kaposvár, 7400
Study site
Pécs, 7624
Study site
Szigetvár, 7900
Romania7 sites
Study site
Brasov, 500152
Study site
Bucharest, 010731
Study site
Bucharest, 020475
Study site
Bucharest, 050098
Study site
Constanța, 900591
Study site
Oradea, 410469
Study site
Târgu Mureş, 540103
France5 sites
Study site
Brest, 29609
Study site
Grenoble, 38043
Study site
Limoges Cedex1, 87042
Study site
Pierre-Bénite, 69495
Study site
Valenciennes, 59300
Israel5 sites
Study site
Ashkelon, 7827804
Study site
Hadera, 3810101
Study site
Jerusalem, 9112001
Study site
Kfar Saba, 4428164
Study site
Nahariya, 2210001
Poland5 sites
Study site
Bialystok, 15-540
Study site
Poznan, 61-858
Study site
Radom, 26-610
Study site
Szczecin, 70-111
Study site
Żyrardów, 96-300
South Korea4 sites
Study site
Bucheon-si, Gyeonggido, 420-767
Study site
Seoul, 03080
Study site
Seoul, 156-707
Study site
Seoul, 156-755
Australia3 sites
Study site
Gosford, New South Wales, 2250
Study site
Melbourne, Victoria, 3052
Study site
Reservoir, 3073
Turkey (Türkiye)3 sites
Ankara Univ. Medical Faculty
Ankara, 06100
Baskent University Medical Faculty
Ankara, 06490
Sifa University Medical Faculty
Izmir, 03540
About this study
Official title: A Controlled, Parallel Group, Open-label, Multicenter Extension Study to Investigate Efficacy and Safety of Oral BAY85-3934 and Darbepoetin Alfa Comparator in the Long Term Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease 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 extension 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 extension study will enroll up to 240 patients at multiple locations in Europe, Asia and Australia. Patients who participated in Studies 15141 or 15261 may be eligible to take part in the extension study. The study consists of the Haemoglobin (Hb) Stabilisation Phase and the Main Phase. The Hb Stabilisation Phase involves up to 10 study visits scheduled over 16 weeks. The Main Phase will last for at least 6 months and up to a maximum of 36 months, with visits every 4 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. This study will include subjects who either completed the treatment period in their respective Phase 2 parent study (i.e., Study 15141 or Study 15261) or experienced a stopping event in the fixed dose parent study (Study 15141). As Study 15141 is a double-blind study, subjects will be unblinded as per the Study 15141 protocol prior to entry into the extension study.
- Conditions
- Anemia, Renal Insufficiency, Chronic
- Being tested
- Molidustat (BAY85-3934), Darbepoetin
- 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.
Molidustat (BAY85-3934)Drug
BAY85-3934 will be titrated at the scheduled dose control visits to maintain the Hb in the target range of 10.0 to 12.0 g/dL. Available doses include 15, 25, 50, 75, 100, and 150 mg/day OD. Treatment will be for minimum of 6 months to up to a maximum of 36 months.
DarbepoetinBiological
Darbepoetin will be administered according to the local label and titrated at the scheduled dose by intravenous injection. Treatment will be for a minimum of 6 months to up to a maximum of 36 months.
| Study group | Role | What they receive |
|---|---|---|
| BAY85-3934 | Experimental | Not described Receives: Drug: Molidustat (BAY85-3934) |
| Darbepoetin | Active comparator | Not described Receives: Biological: Darbepoetin |
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
Measured: Baseline up to 36 months
Number of participants with serious adverse events (SAEs) and adjucated adverse events as a measure of safety and tolerability
Measured: Up to 36 months
Number of participants with liver function-related AEs including abnormal liver function tests and any hospitalization
Measured: Up to 36 months
Secondary outcomes (14)
Time within hemoglobin target range (10.0 to 12.0 g/dL)
Measured: Up to 36 months
Duration of treatment exposure
Measured: Up to 36 months
Number of subjects requiring titration of dose
Measured: Up to 36 months
Change of reticulocyte count from baseline of this study
Measured: Baseline up to 36 months
Change of red blood cell count from baseline of this study
Measured: Baseline up to 36 months
Change of hematocrit from baseline of this study
Measured: Baseline up to 36 months
Change of central laboratory hemoglobin level from baseline of this study
Measured: Baseline up to 36 months
Responders in Hb levels
Measured: Up to 36 months
Number of subjects meeting specific Hb criteria
Measured: Baseline up to 36 months
Number of subjects with Hb values >13 g/dL or having excessive Hb increase
Measured: Baseline up to 36 months
Number of participants with non-serious adverse events
Measured: Up to 36 months
Change in heart rate (HR)
Measured: Up to 36 months
Change in blood pressure (BP)
Measured: Up to 36 months
Laboratory abnormalities
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study start24 Jun 2014
- Primary completion15 Nov 2016
- Study completion12 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 166 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
- NCT02055482
- Sponsor's protocol ID
- 15653
- Other IDs
- 2013-001190-24
- Acronym
- DIALOGUE 3
- Status last verified
- Nov 2017
- First submitted
- 4 Feb 2014
- Last updated
- 22 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled, Parallel Group, Open-label, Multicenter Extension Study to Investigate Efficacy and Safety of Oral BAY85-3934 and Darbepoetin Alfa Comparator in the Long Term Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease in Europe and Asia Pacific
- ClinicalTrials.gov ID
- NCT02055482
- Acronym / sponsor ID
- DIALOGUE 3 / 15653
- Conditions
- Anemia, Renal Insufficiency, Chronic
- Keywords
- Anemia on CKD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2014 (actual)
- Primary completion
- 15 Nov 2016 (actual)
- Study completion
- 12 Dec 2016 (actual)
- First posted
- 5 Feb 2014 (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 extension 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 extension study will enroll up to 240 patients at multiple locations in Europe, Asia and Australia. Patients who participated in Studies 15141 or 15261 may be eligible to take part in the extension study. The study consists of the Haemoglobin (Hb) Stabilisation Phase and the Main Phase. The Hb Stabilisation Phase involves up to 10 study visits scheduled over 16 weeks. The Main Phase will last for at least 6 months and up to a maximum of 36 months, with visits every 4 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. This study will include subjects who either completed the treatment period in their respective Phase 2 parent study (i.e., Study 15141 or Study 15261) or experienced a stopping event in the fixed dose parent study (Study 15141). As Study 15141 is a double-blind study, subjects will be unblinded as per the Study 15141 protocol prior to entry into the extension study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAY85-3934 | Experimental | Drug: Molidustat (BAY85-3934) |
| Darbepoetin | Active comparator | Biological: Darbepoetin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men who agree to use adequate contraception when sexually active or women without childbearing potential
- Not on dialysis at study entry
- Serum ferritin levels ≥ 100 μg/L and < 1000 μg/L or transferrin saturation ≥ 20%
- Inclusion criteria for inclusion into the Hb Stabilization (HbS) Phase: Requires Hb stabilization (at 10.0 to 12..0g/dL for a minimum of 4 weeks) as follows: Received BAY 85-3934 and reached a stopping event in Study 15141 or received placebo and reached a stopping event in Study 15141 or completed 16 weeks of treatment with BAY 85-3934 in Study 15141or 15261 but had mean Hb during the evaluation period outside the target range of 10.0 to 12.0 g/dL, or Completed 16 weeks of treatment with placebo in Study 15141 and was re-assessed at 4 weeks after end of study as eligible for Study 15653 (this study)
- Inclusion criteria for inclusion into the Main Phase: Mean Hb concentration of 10.0 to 12.0 g/dL who completed 16 weeks of treatment (BAY85-3934 arm) in Study 15141, or completed 16 weeks of treatment (BAY-3934 or darbepoetin arm)in study 15261 without a dose suspension lasting > 6 consecutive weeks, or mean Hb concentration of 10.0 to 12.0g/dL during the HbS phase of Study 15653 for a minimum of 4 weeks after visit 3.
Key exclusion criteria (8 listed)
- A scheduled kidney transplant or any other organ transplant within the next 6 months (being on a waiting list does not exclude the subject)
- Red blood cell (RBC) containing transfusion within the 8 weeks before baseline
- Phosphodiesterase type 5 (PDE5) inhibitor (e.g., sildenafil, vardenafil, tadalafil) or nitrates
- Sustained, poorly controlled arterial hypertension or hypotension at baseline, defined as blood pressure ≥ 180/110 mmHg or systolic blood pressure < 95 mmHg, respectively
- Severe rhythm or conduction disorders (e.g., heart rate [HR] < 50 or > 110 bpm, atrial flutter, prolonged QT > 500 msec, second or third degree atrioventricular [AV] block), if not reacted with a pace marker)
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 |
|---|---|---|
| Molidustat (BAY85-3934)BAY85-3934 will be titrated at the scheduled dose control visits to maintain the Hb in the target range of 10.0 to 12.0 g/dL. Available doses include 15, 25, 50, 75, 100, and 150 mg/day OD. Treatment will be for minimum of 6 months to up to a maximum of 36 months. | Drug | BAY85-3934 |
| DarbepoetinDarbepoetin will be administered according to the local label and titrated at the scheduled dose by intravenous injection. Treatment will be for a minimum of 6 months to up to a maximum of 36 months. | Biological | Darbepoetin |
Primary outcome
Change in local laboratory hemoglobin level from baseline
Time frame: Baseline up to 36 months
Number of participants with serious adverse events (SAEs) and adjucated adverse events as a measure of safety and tolerability
Time frame: Up to 36 months
Number of participants with liver function-related AEs including abnormal liver function tests and any hospitalization
Time frame: Up to 36 months
14 secondary outcomes
Time within hemoglobin target range (10.0 to 12.0 g/dL)
Time frame: Up to 36 months
Duration of treatment exposure
Time frame: Up to 36 months
Number of subjects requiring titration of dose
Time frame: Up to 36 months
Change of reticulocyte count from baseline of this study
Time frame: Baseline up to 36 months
Change of red blood cell count from baseline of this study
Time frame: Baseline up to 36 months
Change of hematocrit from baseline of this study
Time frame: Baseline up to 36 months
Change of central laboratory hemoglobin level from baseline of this study
Time frame: Baseline up to 36 months
Responders in Hb levels
Time frame: Up to 36 months
Number of subjects meeting specific Hb criteria
Time frame: Baseline up to 36 months
Number of subjects with Hb values >13 g/dL or having excessive Hb increase
Time frame: Baseline up to 36 months
Number of participants with non-serious adverse events
Time frame: Up to 36 months
Change in heart rate (HR)
Time frame: Up to 36 months
Change in blood pressure (BP)
Time frame: Up to 36 months
Laboratory abnormalities
Time frame: Up to 36 months
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 22 Nov 2017.
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Link provided by the sponsor.
Related trials for Anemia
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
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
105 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 Molidustat (BAY85-3934) and Darbepoetin in people with Anemia and Renal Insufficiency, Chronic, run by Bayer at 105 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 5 inclusion and 8 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 22 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 105 sites in United Kingdom, Bulgaria, Japan, Italy, Spain 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 (time frame: Baseline up to 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2017.