AnemiaPhase 2NCT00048048
A Study of Mircera in Anemic Patients With Chronic Kidney Disease Not Yet on Dialysis.
A Phase 2 study testing methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 15 sites in 5 countries.
Trial summary
This study will evaluate the efficacy and safety of different subcutaneous starting doses and dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on dialysis. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- methoxy polyethylene glycol-epoetin beta [Mircera]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 15 sitesin 5 countries
- Study dates
- Mar 2002to Nov 2004
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- adult patients >=18 years of age;
- chronic renal anemia;
- not receiving renal replacement therapy.
Who cannot join
- women who are pregnant, breastfeeding or using unreliable birth control methods;
- administration of any investigational drug within 30 days preceding the screening visit and during the run-in period.
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
United States6 sites
Study site
Birmingham, Alabama, 35211
Study site
Detroit, Michigan, 48202-2689
Study site
Detroit, Michigan, 48236
Study site
Las Vegas, Nevada, 89106
Study site
Portland, Oregon, 97201-2940
Study site
San Diego, California, 92103-8342
Poland3 sites
Study site
Gdansk, 80-211
Study site
Krakow, 31-501
Study site
Wroclaw, 50-417
Canada2 sites
Study site
Edmonton, Alberta, T6G 2B7
Study site
Vancouver, British Columbia, V6Z 1Y6
United Kingdom2 sites
Study site
Belfast, BT9 7LJ
Study site
London, SE22 8PT
About this study
Official title: An Open-label, Randomized, Multi-centre, Multiple Dose Trial to Investigate the Efficacy and Safety of Subcutaneous Injections of RO0503821 at Different Dosing Intervals in Patients With Chronic Renal Anemia Who Are Not on Renal Replacement Therapy
This study will evaluate the efficacy and safety of different subcutaneous starting doses and dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on dialysis. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.
- Conditions
- Anemia
- Being tested
- methoxy polyethylene glycol-epoetin beta [Mircera]
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methoxy polyethylene glycol-epoetin beta [Mircera]Drug
Differing doses and frequencies of sc administration
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (RO0503821, 0.15 mcg/kg 1x/Week) | Experimental | Eligible participants will be receiving RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) at a dose of 0.15 microgram per kilogram (mcg/kg) subcutaneously (SC) once every week to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
| Cohort 2 (RO0503821, 0.3 mcg/kg 1x/Week) | Experimental | Eligible participants will be receiving RO0503821 at a dose of 0.3 mcg/kg SC once every week to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
| Cohort 3 (RO0503821, 0.6 mcg/kg 1x/Week) | Experimental | Eligible participants will be receiving RO0503821 at a dose of 0.6 mcg/kg SC once every week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
| Cohort 4 (RO0503821, 0.3 mcg/kg 1x/2 Week) | Experimental | Eligible participants will be receiving RO0503821 at a dose of 0.3 mcg/kg SC once every two week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
| Cohort 5 (RO0503821, 0.6 mcg/kg 1x/2Week) | Experimental | Eligible participants will be receiving RO0503821 at a dose of 0.6 mcg/kg SC once every two week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
| Cohort 6 (RO0503821, 1.2 mcg/kg 1x/2 Week) | Experimental | Eligible participants will be receiving RO0503821 at a dose of 1.2 mcg/kg SC once every two week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
| Cohort 7 (RO0503821, 0.45 mcg/kg 1x/3 Week) | Experimental | Eligible participants will be receiving RO0503821 at a dose of 0.45 mcg/kg SC once every three week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
| Cohort 8 (RO0503821, 0.9 mcg/kg 1x/3Week) | Experimental | Eligible participants will be receiving RO0503821 at a dose of 0.9 mcg/kg SC once every three week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
| Cohort 9 (RO0503821,1.8 mcg/kg 1x/3 Week) | Experimental | Eligible participants will be receiving RO0503821 at a dose of 1.8 mcg/kg SC once every three week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change in Hemoglobin Over Time Between Baseline and End of Initial Treatment Based on Individual Regression Slopes
The primary efficacy variable was blood Hb level and its changes from Baseline (defined as the mean Hb of Screening assessment (SA) (Week -3), Weeks -2 and -1 of the Run-in period) over time during the core treatment period. For each participant, the primary efficacy parameter was the change in hemoglobin level over time based on regression slopes. All values until end-of-initial treatment (EOIT), defined as the last observed value before a dose change or blood transfusion, were included in the calculation of this endpoint. For participants without any dose adjustments, the EOIT value was identical to the value for Week 19.
Measured: From Baseline (Day -28 to Day 1) to EOIT (Week 19)
Secondary outcomes (6)
Hematocrit Levels at End of Initial Treatment Under Constant Dosing Regimen
Hematocrit (Hct) levels at end of initial treatment under constant dosing regimen were reported. Baseline (Day -28 to Day 1) Hct values was calculated as the mean of the SA (Week -3) and Run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed Hct value before a dose change or blood transfusion. For participants without any dose adjustments, the EOIT value was identical to the value for Week 19.
Measured: From Baseline (Day -28 to Day 1) to EOIT (Week 19)
Reticulocyte Count at End of Initial Treatment Under Constant Dosing Regimen
Reticulocyte levels at EOIT under constant dosing regimen was analysed and reported. Baseline (Day -28 to Day 1) reticulocyte values were calculated as the mean of the SA (Week -3) and Run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed reticulocyte count before a dose change or blood transfusion. For participants without any dose adjustments, the EOIT value was identical to the value for Week 19.
Measured: From Baseline (Day -28 to Day 1) to EOIT (Week 19)
Number of Participants With Any Serious Adverse Events and Any Adverse Events
An Adverse Events (AEs) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Events (SAEs) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only.
Measured: Up to Week 125
Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes Over Time
Marked abnormality was defined as above and/or below a value (according to the Roche specified limits) which was considered to be potentially clinically relevant. The Roche reference range are: white blood cells (WBC) (3.0-18.0 10^9 cells/L), platelets (100-550 10^9 cells/L), alanine aminotransferase (ALT) [0-110 units per litre (U/L)], alkaline phosphatase (ALP) (0-220 U/L), aspartate aminotransferase (AST) (0-80 U/L), albumin >= 30 g/L, phosphate [0.75 - 1.60 millimoles per liter (mmol/L)], potassium (2.9 - 5.8 mmol/L), total bilirubin (0-17 µmol/L), lymphocytes (1- 4.80 10^9 cells/L), eosinophils (0 - 0.45 10^9 cells/L), monocytes (0 - 0.8 10^9 cells/L), and neutrophils (1.80 - 7.70 10^9 cells/L). The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time, all results for the two long term safety periods were displayed by dose schedule group only.
Measured: Up to Week 125
Heart Rate Over Time
Heart rate was defined as the measure of heart beats per minute (bpm). The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only.
Measured: Up to Week 125
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure
Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) is calculated as the end of treatment values minus the Baseline value. Baseline (Day -28 to Day 1) values were calculated as the mean of the SA (Week -3) and Run-in period (Week -2 and Week -1).
Measured: From Baseline (Day -28 to Day 1) to Week 125
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2002 (estimated)
- Study startMar 2002
- Primary completionOct 2003
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00048048
- Sponsor's protocol ID
- BA16528
- Status last verified
- May 2017
- First submitted
- 24 Oct 2002
- Last updated
- 2 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Multi-centre, Multiple Dose Trial to Investigate the Efficacy and Safety of Subcutaneous Injections of RO0503821 at Different Dosing Intervals in Patients With Chronic Renal Anemia Who Are Not on Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT00048048
- Acronym / sponsor ID
- BA16528
- Conditions
- Anemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- Primary completion
- Oct 2003 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 25 Oct 2002 (estimated)
- Results
- Posted 2 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and safety of different subcutaneous starting doses and dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on dialysis. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (RO0503821, 0.15 mcg/kg 1x/Week) | Experimental | Drug: methoxy polyethylene glycol-epoetin beta [Mircera]Eligible participants will be receiving RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) at a dose of 0.15 microgram per kilogram (mcg/kg) subcutaneously (SC) once every week to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. |
| Cohort 2 (RO0503821, 0.3 mcg/kg 1x/Week) | Experimental | Drug: methoxy polyethylene glycol-epoetin beta [Mircera]Eligible participants will be receiving RO0503821 at a dose of 0.3 mcg/kg SC once every week to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. |
| Cohort 3 (RO0503821, 0.6 mcg/kg 1x/Week) | Experimental | Drug: methoxy polyethylene glycol-epoetin beta [Mircera]Eligible participants will be receiving RO0503821 at a dose of 0.6 mcg/kg SC once every week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. |
| Cohort 4 (RO0503821, 0.3 mcg/kg 1x/2 Week) | Experimental | Drug: methoxy polyethylene glycol-epoetin beta [Mircera]Eligible participants will be receiving RO0503821 at a dose of 0.3 mcg/kg SC once every two week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. |
| Cohort 5 (RO0503821, 0.6 mcg/kg 1x/2Week) | Experimental | Drug: methoxy polyethylene glycol-epoetin beta [Mircera]Eligible participants will be receiving RO0503821 at a dose of 0.6 mcg/kg SC once every two week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. |
| Cohort 6 (RO0503821, 1.2 mcg/kg 1x/2 Week) | Experimental | Drug: methoxy polyethylene glycol-epoetin beta [Mircera]Eligible participants will be receiving RO0503821 at a dose of 1.2 mcg/kg SC once every two week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. |
| Cohort 7 (RO0503821, 0.45 mcg/kg 1x/3 Week) | Experimental | Drug: methoxy polyethylene glycol-epoetin beta [Mircera]Eligible participants will be receiving RO0503821 at a dose of 0.45 mcg/kg SC once every three week, to complete the dosage of 0.9 mcg/kg up to 6 weeks (Week 1 to Week 6). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. |
| Cohort 8 (RO0503821, 0.9 mcg/kg 1x/3Week) | Experimental | Drug: methoxy polyethylene glycol-epoetin beta [Mircera]Eligible participants will be receiving RO0503821 at a dose of 0.9 mcg/kg SC once every three week, to complete the dosage of 1.8 mcg/kg up to 6 weeks (Week 7 to Week 12). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. |
| Cohort 9 (RO0503821,1.8 mcg/kg 1x/3 Week) | Experimental | Drug: methoxy polyethylene glycol-epoetin beta [Mircera]Eligible participants will be receiving RO0503821 at a dose of 1.8 mcg/kg SC once every three week, to complete the dosage of 3.6 mcg/kg up to 6 weeks (Week 13 to Week 18). Participants will be followed-up for one week post the treatment period. During extension Years 1 and 2, the participants will remain at the same frequency of administration as that of core treatment period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients >=18 years of age;
- chronic renal anemia;
- not receiving renal replacement therapy.
Key exclusion criteria (2 listed)
- women who are pregnant, breastfeeding or using unreliable birth control methods;
- administration of any investigational drug within 30 days preceding the screening visit and during the run-in period.
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 |
|---|---|---|
| methoxy polyethylene glycol-epoetin beta [Mircera]Differing doses and frequencies of sc administration | Drug | Cohort 1 (RO0503821, 0.15 mcg/kg 1x/Week), Cohort 2 (RO0503821, 0.3 mcg/kg 1x/Week), Cohort 3 (RO0503821, 0.6 mcg/kg 1x/Week), Cohort 4 (RO0503821, 0.3 mcg/kg 1x/2 Week), Cohort 5 (RO0503821, 0.6 mcg/kg 1x/2Week), Cohort 6 (RO0503821, 1.2 mcg/kg 1x/2 Week), Cohort 7 (RO0503821, 0.45 mcg/kg 1x/3 Week), Cohort 8 (RO0503821, 0.9 mcg/kg 1x/3Week), Cohort 9 (RO0503821,1.8 mcg/kg 1x/3 Week) |
Primary outcome
The Change in Hemoglobin Over Time Between Baseline and End of Initial Treatment Based on Individual Regression Slopes
Time frame: From Baseline (Day -28 to Day 1) to EOIT (Week 19)
The primary efficacy variable was blood Hb level and its changes from Baseline (defined as the mean Hb of Screening assessment (SA) (Week -3), Weeks -2 and -1 of the Run-in period) over time during the core treatment period. For each participant, the primary efficacy parameter was the change in hemoglobin level over time based on regression slopes. All values until end-of-initial treatment (EOIT), defined as the last observed value before a dose change or blood transfusion, were included in the calculation of this endpoint. For participants without any dose adjustments, the EOIT value was identical to the value for Week 19.
6 secondary outcomes
Hematocrit Levels at End of Initial Treatment Under Constant Dosing Regimen
Time frame: From Baseline (Day -28 to Day 1) to EOIT (Week 19)
Reticulocyte Count at End of Initial Treatment Under Constant Dosing Regimen
Time frame: From Baseline (Day -28 to Day 1) to EOIT (Week 19)
Number of Participants With Any Serious Adverse Events and Any Adverse Events
Time frame: Up to Week 125
Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes Over Time
Time frame: Up to Week 125
Heart Rate Over Time
Time frame: Up to Week 125
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure
Time frame: From Baseline (Day -28 to Day 1) to Week 125
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clinical Trials study director
Hoffmann-La Roche
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 15 sites in 5 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 3 inclusion and 2 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 2 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Poland, Canada, Mexico, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 2 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Change in Hemoglobin Over Time Between Baseline and End of Initial Treatment Based on Individual Regression Slopes (time frame: From Baseline (Day -28 to Day 1) to EOIT (Week 19)). 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 2 Jan 2018.