AnemiaPhase 3NCT00882713
A Study of Once Monthly Subcutaneous Mircera in Dialysis Patients With Chronic Renal Anemia
A Phase 3 study testing methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 12 sites in Morocco.
Trial summary
This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in dialysis 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 [Mircera]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 12 sitesMorocco
- Study dates
- Feb 2009to Oct 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;
- regular long-term hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months;
- continuous iv maintenance epoetin alfa therapy with same dosing interval during previous 2 months.
Who cannot join
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension;
- significant acute or chronic bleeding;
- active malignant disease (except non-melanoma skin cancer).
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Morocco12 sites
Study site
Agadir, 70000
Study site
Casablanca, 20000
Study site
Casablanca, 20100
Study site
Casablanca, 21000
Study site
FÉS, 30000
Study site
Khouribga, 23000
Study site
Marrakesh, 40000
Study site
Méknés, 50300
Study site
Rabat, 10150
Study site
Rabat, 62001
Study site
Salé, 15045
Study site
Tangier, 90000
About this study
Official title: A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once- Monthly Administration of Subcutaneous CERA for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anemia
This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients will receive subcutaneous Mircera at a starting dose of 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of epoetin or darbepoetin alfa previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. Treatment duration is 56 weeks, and the target sample size is 200 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
Also called C.E.R.A.
Subcutaneous injection every 4 weeks (starting dose of 120, 200 or 360 micrograms, based on previous ESA therapy)
| Study group | Role | What they receive |
|---|---|---|
| C.E.R.A. | Experimental | Eligible participants will be administered continuous erythropoietin receptor activator (C.E.R.A.[Mircera]) intravenously (IV) every 4 weeks for 44 weeks. The starting dose of 120, 200, or 360 micrograms (mcg) will be based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses will be adjusted to maintain the individual participant's hemoglobin (Hb) within a range of +/- 1.0 grams per deciliter (g/dL) of the reference hemoglobin (Hb) concentration and between 10.50 and 12.50 g/dL. 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.
Percentage of Participants Maintaining Mean Hemoglobin Concentration Within +/- 1 g/dL of Their Reference Hb and Between 10.5 and 12.5 g/dL During Efficacy Evaluation Period
The percentage of participants who maintained their mean Hb concentration within +/- 1 g/dL of their reference Hb and between 10.5 and 12.5 g/dL during the Efficacy Evaluation Period (EEP) is reported. The EEP was from Week 17 to Week 24. The reference Hb was calculated from the mean of Hb concentrations based upon the Hb assessments at Weeks -4, -3, -2, -1, and 0.
Measured: EEP (Week 17 to Week 24)
Secondary outcomes (18)
Mean Change in Hemoglobin Concentration Between Reference (Stability Verification Period) and the Efficacy Evaluation Period
Mean change in Hb concentration between reference SVP and the EEP is reported. The SVP was at Weeks -3, -2, -1, and EEP was from Week 17 to Week 24. Participants received epoetin alfa or beta during SVP.
Measured: SVP (Weeks -3, -2, -1) and EEP (Week 17 to Week 24)
Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.5-12.5 g/dL Throughout the EEP
Percentage of participants maintaining Hb concentration within the range of 10.5-12.5 g/dL throughout the EEP is reported. The EEP was from Week 17 to Week 24.
Measured: EEP (Week 17 to Week 24)
Mean Time Spent By Participants With Hemoglobin Range of 10.5-12.5 g/dL During the EEP
Mean time spent by participants in Hb range of 10.5-12.5 g/dL during the EEP is reported. The EEP was from Week 17 to Week 24.
Measured: EEP (Week 17 to Week 24)
Number of Participants With Any Adverse Events or Serious Adverse Events
An adverse event (AE) is untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAEs) is with any of the following outcomes: Death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, and congenital anomaly.
Measured: Up to Week 52
Percentage of Participants Requiring Any Dose Adjustment During DTP and EEP
Percentage of participants requiring any dose adjustment during DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24) is reported. The dose adjustments (increase or decrease) were required: if a single Hb concentration was either > or = 13 g/dL or < or = 9 g/dL; if the difference of 2 consecutive Hb concentrations was > or =2 g/dL; if the values of scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of range of 10.5 to 11.5 g/dL, the difference between the reference value (mean of Hb concentrations based on the Hb assessments at Weeks -4, -3, -2, -1, and 0) and the most recent value was >1 g/dL; if the values of the scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of the range 10 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.
Measured: DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24)
Incidences of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase
Red Blood Cells (RBCs) transfusions were given during the treatment period in case of medical need. Blood transfusions occurred during the DTP, EEP, and during the long term safety period (LTSP) were reported.
Measured: Up to Week 52
Mean Hemoglobin Levels Over Time
The Hb levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Measured: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Hematocrit Levels Over Time
The hematocrit (HCT) levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Measured: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Albumin Levels Over Time
The albumin levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Measured: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean White Blood Cells and Thrombocytes Over Time
The white blood cells (WBCs) and thrombocyte levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Measured: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Phosphate and Potassium Levels Over Time
The phosphate and potassium levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Measured: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
The mean creatinine, iron, and total iron binding capacity (TIBC) levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Measured: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean C-Reactive Protein Levels Over Time
The mean C-Reactive Protein (CRP) Levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Measured: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Ferritin Levels Over Time
The mean ferritin levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Measured: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Transferrin Saturation Levels Over Time
The mean transferrin saturation (TSAT) levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.
Measured: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Change From Baseline in Pulse Rate Over Time
Mean change in pulse rate was defined as the difference between mean pulse rate at Baseline and following visits (Weeks 8, 16, 24, 32, 40, and 48).
Measured: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Change From Baseline in Blood Pressure Over Time
Mean change in blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) before and after dialysis was defined as the difference between mean blood pressure at Baseline and following visits (Weeks 8, 16, 24, 32, 40, and 48).
Measured: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Change From Baseline in Weight Over Time
Mean change in weight was defined as the difference between mean weight at Baseline and following visits (Week 16 and Week 48).
Measured: Week 16 and Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2009 (estimated)
- Study startFeb 2009
- Primary completionOct 2010
- Study completionOct 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
- 202 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
- NCT00882713
- Sponsor's protocol ID
- ML21797
- Status last verified
- Aug 2016
- First submitted
- 17 Feb 2009
- Last updated
- 7 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
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 7 Oct 2016. 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 Subcutaneous CERA for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anemia
- ClinicalTrials.gov ID
- NCT00882713
- Acronym / sponsor ID
- ML21797
- Conditions
- Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 16 Apr 2009 (estimated)
- Results
- Posted 7 Oct 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 subcutaneous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients will receive subcutaneous Mircera at a starting dose of 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of epoetin or darbepoetin alfa previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. Treatment duration is 56 weeks, and the target sample size is 200 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. | Experimental | Drug: methoxy polyethylene glycol-epoetin beta [Mircera]Eligible participants will be administered continuous erythropoietin receptor activator (C.E.R.A.[Mircera]) intravenously (IV) every 4 weeks for 44 weeks. The starting dose of 120, 200, or 360 micrograms (mcg) will be based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses will be adjusted to maintain the individual participant's hemoglobin (Hb) within a range of +/- 1.0 grams per deciliter (g/dL) of the reference hemoglobin (Hb) concentration and between 10.50 and 12.50 g/dL. |
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;
- regular long-term hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months;
- continuous iv maintenance epoetin alfa therapy with same dosing interval during previous 2 months.
Key exclusion criteria (4 listed)
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension;
- significant acute or chronic bleeding;
- active malignant disease (except non-melanoma skin cancer).
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]Also: C.E.R.A.Subcutaneous injection every 4 weeks (starting dose of 120, 200 or 360 micrograms, based on previous ESA therapy) | Drug | C.E.R.A. |
Primary outcome
Percentage of Participants Maintaining Mean Hemoglobin Concentration Within +/- 1 g/dL of Their Reference Hb and Between 10.5 and 12.5 g/dL During Efficacy Evaluation Period
Time frame: EEP (Week 17 to Week 24)
The percentage of participants who maintained their mean Hb concentration within +/- 1 g/dL of their reference Hb and between 10.5 and 12.5 g/dL during the Efficacy Evaluation Period (EEP) is reported. The EEP was from Week 17 to Week 24. The reference Hb was calculated from the mean of Hb concentrations based upon the Hb assessments at Weeks -4, -3, -2, -1, and 0.
18 secondary outcomes
Mean Change in Hemoglobin Concentration Between Reference (Stability Verification Period) and the Efficacy Evaluation Period
Time frame: SVP (Weeks -3, -2, -1) and EEP (Week 17 to Week 24)
Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.5-12.5 g/dL Throughout the EEP
Time frame: EEP (Week 17 to Week 24)
Mean Time Spent By Participants With Hemoglobin Range of 10.5-12.5 g/dL During the EEP
Time frame: EEP (Week 17 to Week 24)
Number of Participants With Any Adverse Events or Serious Adverse Events
Time frame: Up to Week 52
Percentage of Participants Requiring Any Dose Adjustment During DTP and EEP
Time frame: DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24)
Incidences of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase
Time frame: Up to Week 52
Mean Hemoglobin Levels Over Time
Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Hematocrit Levels Over Time
Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Albumin Levels Over Time
Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean White Blood Cells and Thrombocytes Over Time
Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Phosphate and Potassium Levels Over Time
Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time
Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean C-Reactive Protein Levels Over Time
Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Ferritin Levels Over Time
Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Transferrin Saturation Levels Over Time
Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Change From Baseline in Pulse Rate Over Time
Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Change From Baseline in Blood Pressure Over Time
Time frame: Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48
Mean Change From Baseline in Weight Over Time
Time frame: Week 16 and Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
- 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
12 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 [Mircera] in people with Anemia, run by Hoffmann-La Roche at 12 sites in Morocco.
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 4 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 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Morocco. 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 7 Oct 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 Maintaining Mean Hemoglobin Concentration Within +/- 1 g/dL of Their Reference Hb and Between 10.5 and 12.5 g/dL During Efficacy Evaluation Period (time frame: EEP (Week 17 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 NCT00882713, 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 7 Oct 2016.