AnemiaPhase 3NCT00661505
A Study of Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia
A Phase 3 study testing methoxy polyethylene glycol-epoetin beta in people with Anemia, run by Hoffmann-La Roche at 20 sites in Turkey (Türkiye).
Trial summary
This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 20 sitesTurkey (Türkiye)
- Study dates
- 14 May 2008to 22 Jun 2010
- Phase
- Phase 3
- 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;
- continuous stable iv or sc maintenance epoetin therapy during previous 4 weeks;
- regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.
Who cannot join
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension requiring hospitalization or interruption of epoetin treatment in previous 6 months;
- significant acute or chronic bleeding.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Turkey (Türkiye)20 sites
Cukurova University Medical Faculty; Internal Medicine
Adana, 01330
Ankara Research and Training Hospital; The Clinic of Nephrology
Ankara, 06100
Ankara University School of Medicine; Nephrology
Ankara, 06100
Faith University School of Medicine; Nephrology
Ankara, 06100
Hacettepe University Medical Faculty; Department of Internal Medicine
Ankara, 06100
Baskent University Hospital; Transplantation
Ankara, 06490
Gazi University School of Medicine; Nephrology
Ankara, 06500
Adnan Menderes Uni School of Medicine; Physical Therapy & Rehabilitation
Aydin, 09100
Dicle Uni Medical Faculty; Internal Medicine
Diyarbakır, 10000
Trakya University Medical Faculty; Internal Medicine; Nephrology
Edirne, 22030
Firat Uni School Of Medicine; Nephrology
Elâzığ, 23110
Ataturk University Medical Faculty; Department of Internal Medicine
Erzurum, 25240
Sisli Etfal Research and Training Hospital; The Clinic of Nephrology
Istanbul, 34377
Istanbul University Istanbul Medical Faculty; Department of Internal Medicine
Istanbul, 34390
Marmara Uni School of Medicine; Nephrology
Istanbul, 34662
Izmir Ataturk Research and Training Hospital; The Clinic of Nephrology
Izmir, 35290
Dokuz Eylul University School of Medicine; Nephrology
Izmir
Erciyes University School of Medicine; Nephrology
Kayseri, 38039
Inonu Uni School of Medicine
Malatya, 44300
Mersin University Medical Faculty
Mersin, 33169
About this study
Official title: A Single Arm Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Haemodialysis Patients With Chronic Renal Anaemia.
This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Patients will receive 4-weekly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
- Conditions
- Anemia
- Being tested
- methoxy polyethylene glycol-epoetin beta
- 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 betaDrug
120, 200 or 360 micrograms iv every 4 weeks (starting dose)
| Study group | Role | What they receive |
|---|---|---|
| C.E.R.A. 120, 200, or 360 mcg | Experimental | Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28). Receives: Drug: methoxy polyethylene glycol-epoetin beta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Maintained Their Mean Hemoglobin Concentration Within +/- 1.0 Gram/Deciliter of Their Reference Hemoglobin Concentration and Between 10.0 and 12.0 Gram/Deciliter During the Efficacy Evaluation Period
The reference hemoglobin (Hb) value was taken as the time adjusted average of all Hb assessments during the SVP (Week -4 to Week 0). The time adjusted average Hb concentration of all the values recorded during the efficacy evaluation period (EEP) was calculated for each participant and their reference Hb concentration was subtracted from this value. The percentage of participants maintaining their average Hb concentration during the EEP within +/- 1 gram/deciliter (g/dL) of their reference Hb concentration and between the Hb range 10.0 -12.0 g/dL is presented. The EEP was defined as Week 16 to Week 24. Data missing at the end of the EEP was handled using the last value carried forward method, including any data missing due to withdrawal of participants following red blood cells (RBC) transfusion.
Measured: EEP (Week 16 to Week 24)
Secondary outcomes (22)
Mean Change in Hemoglobin Concentration Between the Stability Verification Period and the Efficacy Evaluation Period
The mean change in the time-adjusted average Hb concentration between the two study periods The Stability Verification Period (SVP) and EEP is presented. The SVP was defined as Week -4 to Week 0. The EEP was defined as Week 16 to Week 24.
Measured: SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24)
Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period
The time adjusted average Hb concentration of all the values recorded during the EEP was calculated for each participant. The percentage of participants maintaining their average Hb concentration during the EEP within the Hb concentration range of 10.0-12.0 g/dL is presented. The EEP was defined as Week 16 to Week 24.
Measured: EEP (Week 16 to Week 24)
Median Time Spent in the Hemoglobin Range 10.0-12.0 Gram/Deciliter During the Efficacy Evaluation Period
The Hb concentration was recorded for all the participants during the EEP. The median time spent (in days) by participants in the target range (10.0-12.0 g/dL) during the EEP is presented. The EEP was defined as Week 16 to Week 24.
Measured: EEP (Week 16 to Week 24)
Mean C.E.R.A. Dose Required to Maintain Hemoglobin Level Within the Range 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period
The mean dose of C.E.R.A. required to maintain Hb level between 10.0-12.0 g/dL during the EEP was calculated per participant and then summarized. The EEP was defined as Week 16 to Week 24. However, C.E.R.A. was not administered at the Week 24 visit. Therefore, the time period for calculation of mean C.E.R.A. dose during EEP is from Week 16 to Week 20.
Measured: EEP (Week 16 to Week 20)
Percentage of Participants Requiring Any Dose Adjustments in C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period
Dose adjustments were necessary when Hb increased or decreased by a clinically significant amount. The dose of C.E.R.A. was adjusted to maintain the individual participant's Hb within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.0 and 12.0 g/dL throughout the dose titration period (DTP) and the EEP (Week 1 to Week 24). The reference Hb value was taken as the time adjusted average of all Hb assessments during the SVP (Week -4 to Week 0).
Measured: DTP (Week 1 to Week 16), EEP (Week 16 to Week 24)
Mean Monthly Dose of C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period
The mean monthly dose of C.E.R.A. administered during the DTP and EEP was calculated per participant and then summarized.
Measured: DTP (Week 1 to Week 16), EEP (Week 16 to Week 24)
Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume at Week 16 and Week 24
Mean change from Baseline in erythrocyte mean corpuscular volume (MCV) was calculated as the value at a specific week during the study minus the BL value. The Baseline was defined as Week -4 to Week 0.
Measured: BL (Week -4 to Week 0), Week 16, and Week 24
Mean Change From Baseline in Hematocrit at Week 16 and Week 24
The hematocrit, also called packed cell volume or erythrocyte volume fraction, is the volume percentage of red blood cells in the blood. Mean change from Baseline (BL) in hematocrit was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Measured: BL (Week -4 to Week 0), Week 16, and Week 24
Mean Change From Baseline in Hemoglobin at Week 16 and Week 24
Mean change from BL in hemoglobin was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Measured: BL (Week -4 to Week 0), Week 16, and Week 24
Mean Change From Baseline in Leucocytes and Platelet at Week 16 and Week 24
Mean change from BL in for each parameter (leucocytes and platelet) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Measured: BL (Week -4 to Week 0), Week 16, and Week 24
Mean Change From Baseline in Ferritin at Week 16 and Week 24
Mean change from BL in ferritin was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Measured: BL (Week -4 to Week 0), Week 16, and Week 24
Mean Change From Baseline in Iron, Total Iron Binding Capacity, and Creatinine at Week 16 and Week 24
Mean change from BL in each parameter [iron, total iron binding capacity (TIBC), and creatinine] was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Measured: BL (Week -4 to Week 0), Week 16, and Week 24
Mean Change From Baseline in Transferrin and Albumin at Week 16 and Week 24
Mean change from BL in each parameter (transferrin and albumin) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Measured: BL (Week -4 to Week 0), Week 16, and Week 24
Mean Change From Baseline in Transferrin Saturation at Week 16 and Week 24
Mean change from BL in transferrin saturation (TSAT) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Measured: BL (Week -4 to Week 0), Week 16, and Week 24
Mean Change From Baseline in C-Reactive Protein at Week 16 and Week 24
Mean change from BL in C-reactive protein was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Measured: BL (Week -4 to Week 0), Week 16, and Week 24
Mean Change From Baseline in Phosphate and Potassium at Week 16 and Week 24
Mean change from BL in each parameter (phosphate and potassium) was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Measured: BL (Week -4 to Week 0), Week 16, and Week 24
Mean Change From Baseline in Weight at Week 16 and Week 24
Mean change from BL in weight was calculated as the value at a specific week during the study minus the BL value. The BL was defined as Week -4 to Week 0.
Measured: BL (Week -4 to Week 0), Week 16, and Week 24
Mean Change in From Baseline in Blood Pressure at Week 16 and Week 24
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured before blood sampling and C.E.R.A. administration. Blood pressure was assessed both before and after the dialysis session for participants undergoing hemodialysis. Change from BL in blood pressure was calculated as the value at a specific week (W) during the study minus the BL value. The baseline was defined as Week -4 to Week 0.
Measured: Baseline (Week -4 to Week 0), Week 16, and Week 24
Number of Participants Taking Concomitant Medications
The number of participants taking different classes of concomitant medications at any time following enrollment into the study is presented.
Measured: Up to Week 28
Number of Participants With Any Adverse Events and Serious Adverse Events
An adverse event (AE) is any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be 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. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Measured: Up to Week 28
Number of Participants With Reports of Anti-erythropoietin Antibodies
The number of participants with Anti-epoetin antibodies is presented.
Measured: Up to Week 24
Number of Participants Who Received Red Blood Cell Transfusions During the Dose Titration Period and Efficacy Evaluation Period
Red blood cell transfusions were permitted during the DTP and EEP (Week 1 to Week 24) in case of medical need. All participants requiring a blood transfusion were withdrawn from the study. The number of participants who were administered RBC transfusions during the DTP and EEP is presented.
Measured: Week 1 to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study start14 May 2008
- Primary completion22 Jun 2010
- Study completion22 Jun 2010
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.
- 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 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 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
- NCT00661505
- Sponsor's protocol ID
- ML21096
- Status last verified
- Nov 2017
- First submitted
- 16 Apr 2008
- Last updated
- 6 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10.
PubMed 26965694
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Haemodialysis Patients With Chronic Renal Anaemia.
- ClinicalTrials.gov ID
- NCT00661505
- Acronym / sponsor ID
- ML21096
- Conditions
- Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 14 May 2008 (actual)
- Primary completion
- 22 Jun 2010 (actual)
- Study completion
- 22 Jun 2010 (actual)
- First posted
- 18 Apr 2008 (estimated)
- Results
- Posted 19 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Patients will receive 4-weekly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C.E.R.A. 120, 200, or 360 mcg | Experimental | Drug: methoxy polyethylene glycol-epoetin betaEligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (<8000 IU, 8000-16000 IU, or >16000 IU) or darbepoetin alpha (<40 mcg, 40-80 mcg, or >80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patients, >= 18 years of age;
- chronic renal anemia;
- continuous stable iv or sc maintenance epoetin therapy during previous 4 weeks;
- regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.
Key exclusion criteria (3 listed)
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension requiring hospitalization or interruption of epoetin treatment in previous 6 months;
- significant acute or chronic bleeding.
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 beta120, 200 or 360 micrograms iv every 4 weeks (starting dose) | Drug | C.E.R.A. 120, 200, or 360 mcg |
Primary outcome
Percentage of Participants Who Maintained Their Mean Hemoglobin Concentration Within +/- 1.0 Gram/Deciliter of Their Reference Hemoglobin Concentration and Between 10.0 and 12.0 Gram/Deciliter During the Efficacy Evaluation Period
Time frame: EEP (Week 16 to Week 24)
The reference hemoglobin (Hb) value was taken as the time adjusted average of all Hb assessments during the SVP (Week -4 to Week 0). The time adjusted average Hb concentration of all the values recorded during the efficacy evaluation period (EEP) was calculated for each participant and their reference Hb concentration was subtracted from this value. The percentage of participants maintaining their average Hb concentration during the EEP within +/- 1 gram/deciliter (g/dL) of their reference Hb concentration and between the Hb range 10.0 -12.0 g/dL is presented. The EEP was defined as Week 16 to Week 24. Data missing at the end of the EEP was handled using the last value carried forward method, including any data missing due to withdrawal of participants following red blood cells (RBC) transfusion.
22 secondary outcomes
Mean Change in Hemoglobin Concentration Between the Stability Verification Period and the Efficacy Evaluation Period
Time frame: SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24)
Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period
Time frame: EEP (Week 16 to Week 24)
Median Time Spent in the Hemoglobin Range 10.0-12.0 Gram/Deciliter During the Efficacy Evaluation Period
Time frame: EEP (Week 16 to Week 24)
Mean C.E.R.A. Dose Required to Maintain Hemoglobin Level Within the Range 10.0-12.0 Gram/Deciliter Throughout the Efficacy Evaluation Period
Time frame: EEP (Week 16 to Week 20)
Percentage of Participants Requiring Any Dose Adjustments in C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period
Time frame: DTP (Week 1 to Week 16), EEP (Week 16 to Week 24)
Mean Monthly Dose of C.E.R.A. During the Dose Titration Period and Efficacy Evaluation Period
Time frame: DTP (Week 1 to Week 16), EEP (Week 16 to Week 24)
Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume at Week 16 and Week 24
Time frame: BL (Week -4 to Week 0), Week 16, and Week 24
Mean Change From Baseline in Hematocrit at Week 16 and Week 24
Time frame: BL (Week -4 to Week 0), Week 16, and Week 24
Mean Change From Baseline in Hemoglobin at Week 16 and Week 24
Time frame: BL (Week -4 to Week 0), Week 16, and Week 24
Mean Change From Baseline in Leucocytes and Platelet at Week 16 and Week 24
Time frame: BL (Week -4 to Week 0), Week 16, and Week 24
Mean Change From Baseline in Ferritin at Week 16 and Week 24
Time frame: BL (Week -4 to Week 0), Week 16, and Week 24
Mean Change From Baseline in Iron, Total Iron Binding Capacity, and Creatinine at Week 16 and Week 24
Time frame: BL (Week -4 to Week 0), Week 16, and Week 24
Mean Change From Baseline in Transferrin and Albumin at Week 16 and Week 24
Time frame: BL (Week -4 to Week 0), Week 16, and Week 24
Mean Change From Baseline in Transferrin Saturation at Week 16 and Week 24
Time frame: BL (Week -4 to Week 0), Week 16, and Week 24
Mean Change From Baseline in C-Reactive Protein at Week 16 and Week 24
Time frame: BL (Week -4 to Week 0), Week 16, and Week 24
Mean Change From Baseline in Phosphate and Potassium at Week 16 and Week 24
Time frame: BL (Week -4 to Week 0), Week 16, and Week 24
Mean Change From Baseline in Weight at Week 16 and Week 24
Time frame: BL (Week -4 to Week 0), Week 16, and Week 24
Mean Change in From Baseline in Blood Pressure at Week 16 and Week 24
Time frame: Baseline (Week -4 to Week 0), Week 16, and Week 24
Number of Participants Taking Concomitant Medications
Time frame: Up to Week 28
Number of Participants With Any Adverse Events and Serious Adverse Events
Time frame: Up to Week 28
Number of Participants With Reports of Anti-erythropoietin Antibodies
Time frame: Up to Week 24
Number of Participants Who Received Red Blood Cell Transfusions During the Dose Titration Period and Efficacy Evaluation Period
Time frame: Week 1 to Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26965694Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10.
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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
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing methoxy polyethylene glycol-epoetin beta in people with Anemia, run by Hoffmann-La Roche at 20 sites in Turkey (Türkiye).
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 4 inclusion and 3 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 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Turkey (Türkiye). 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 19 Jul 2016). 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?
Percentage of Participants Who Maintained Their Mean Hemoglobin Concentration Within +/- 1.0 Gram/Deciliter of Their Reference Hemoglobin Concentration and Between 10.0 and 12.0 Gram/Deciliter During the Efficacy Evaluation Period (time frame: EEP (Week 16 to Week 24)). 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 NCT00661505, 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 6 Dec 2017.