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AnemiaPhase 3NCT00560404

A Study of Subcutaneous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.

A Phase 3 study testing methoxy polyethylene glycol-epoetin beta [Mircera] and Epoetin alfa in people with Anemia, run by Hoffmann-La Roche at 26 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This 2 arm study will compare the efficacy and safety of monthly administration of subcutaneous Mircera versus epoetin alfa 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] and Epoetin alfa
Could I receive a placebo?
No, everyone receives an active treatment
How many people
233 participants
Where
26 sitesBrazil
Study dates
Apr 2008to Dec 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 hemodialysis with the same schedule of dialysis for >=12 weeks;
  • maintenance therapy with subcutaneous epoetin alfa at the same administration interval for 4 weeks.

Who cannot join

  • transfusion of red blood cells during previous 2 months;
  • poorly controlled hypertension requiring interruption of epoetin alfa in previous 6 months;
  • acute or chronic bleeding;
  • active malignant disease (except non-melanoma skin cancer).

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

Brazil26 sites

  • Study site

    Belo Horizonte, 30150-320

  • Study site

    Brasília, 70390-108

  • Study site

    Campinas, 13086-970

  • Study site

    Campo Grande, 79002-073

  • Study site

    Cariacica, 29152-230

  • Study site

    Curitiba, 80050-350

  • Study site

    Curitiba, 80440-020

  • Study site

    Fortaleza, 60430160

  • Study site

    Jaboatão dos Guararapes, 54400-170

  • Study site

    Joinville, 89227-680

  • Study site

    Juiz de Fora, 36036900

  • Study site

    Londrina, 86015-000

  • Study site

    Natal, 59020-110

  • Study site

    Porto Alegre, 90035-903

  • Study site

    Porto Alegre, 90610000

  • Study site

    Ribeirão Preto, 14025-170

  • Study site

    Rio de Janeiro

  • Study site

    Salvador, 40110-060

  • Study site

    São José do Rio Preto, 15090-000

  • Study site

    São Luís, 65020-305

  • Study site

    São Paulo, 01246-903

  • Study site

    São Paulo, 01323-900

  • Study site

    São Paulo, 01532-001

  • Study site

    São Paulo, 03065-000

  • Study site

    São Paulo, O4023

  • Study site

    Sorocaba, 18030-210

Other trials in Brazil

About this study

Official title: A Randomized, Open Label Study to Compare the Effect of Once Monthly Administration of Subcutaneous Mircera Versus Epoetin Alfa on Maintenance of Hemoglobin Levels, Safety and Tolerability in Dialysis Patients With Chronic Renal Anemia.

This 2 arm study will compare the efficacy and safety of monthly administration of subcutaneous Mircera versus epoetin alfa for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients currently receiving maintenance treatment with epoetin alfa will be randomized to receive either monthly injections of Mircera with a starting dose (120, 200 or 360 micrograms) derived from the dose of epoetin alfa they were receiving in the week preceding study start, or to continue on epoetin alfa treatment. 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 [Mircera], Epoetin alfa
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

    120, 200 or 360 micrograms sc monthly (starting dose)

  • Epoetin alfaDrug

    As prescribed

Study groups in NCT00560404
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
2Active comparatorNot described
Receives: Drug: Epoetin alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Maintaining Their Mean Hemoglobin Concentration Within Plus or Minus 1 Gram/Deciliter of Their Reference Hemoglobin and Between the Target Range During Efficacy Evaluation Period

    The target hemoglobin (Hb) range was defined as Hb concentration (gram/deciliter [g/dL]) between 10.5 and 12.5 g/dL during the efficacy evaluation period (EEP). EEP was from Week 29 to Week 36.

    Measured: EEP (Week 29 to Week 36)

Secondary outcomes (18)

  1. Mean Change From Baseline in Hemoglobin Concentration Between Baseline and at the Efficacy Evaluation Period

    The Baseline (Safety Verification Period) was from Week - 4 to Week -1.

    Measured: Baseline (Weeks -4 to 0) and at EEP (Weeks 29 to 36)

  2. Percentage of Participants Maintaining Individual Hemoglobin Concentration Within the Range of 10.5 - 12.5 Gram/Decilitre Throughout the Efficacy Evaluation Period

    Percentage of participants maintaining individual Hb concentration within the Hb range 10.5 - 12.5 g/dL were reported during EEP. The EEP was from Week 29 to Week 36 of the study period.

    Measured: EEP (Weeks 29 to 36)

  3. Mean Time Spent in Hemoglobin Range of 10.5 - 12.5 Gram/Decilitre During the Efficacy Evaluation Period

    Mean time to maintain Hb in the range of 10.5-12.5 g/dL during EEP is presented.

    Measured: EEP (Week 29 to Week 36)

  4. Number of Participants Who Required Dose Adjustments During the Dose Titration Period

    The number of participants who required dose adjustments of C.E.R.A and epoetin alpha were reported during the Dose Titration Period (DTP). The DTP was from Week 0 to Week 28.

    Measured: DTP (Weeks 0 to 28)

  5. Number of Participants Who Required Dose Adjustments During the Efficacy Evaluation Period

    The number of participants who required dose adjustments of C.E.R.A and epoetin alpha were reported during the Efficacy Evaluation Period (EEP). The EEP was from Week 29 to Week 36.

    Measured: EEP (Weeks 29 to 36)

  6. Number of Participants Received Red Blood Cells Transfusions

    The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study was reported. For this study, blood transfusion was reported during the titration period. No transfusion occurred in the EEP.

    Measured: Up to Week 28

  7. Mean Values of Hemoglobin Concentration at Baseline and Week 36

    The mean Hb concentration for each participant throughout the study was estimated. Summary data of mean values of Hb concentration at Baseline and Week 36 are presented.

    Measured: Baseline and Week 36

  8. Mean Values of Hematocrit at Baseline and Week 36

    Hematocrit is the volume percentage of red blood cells in blood. The mean hematocrit for each participant was estimated throughout the study. Summary data of mean values of Hb at Baseline and Week 36 are presented.

    Measured: Baseline and Week 36

  9. Mean Values of Mean Corpuscular Volume at Baseline and Week 36

    Mean corpuscular volume (MCV) is the average volume of red cells. The mean MCV concentration for each participant throughout the study was estimated. Summary data of mean values of MCV concentration at Baseline and Week 36 are presented.

    Measured: Baseline and Week 36

  10. Mean Values of Leukocytes and Platelets Count at Baseline and Week 36

    The mean values of laboratory parameters: leukocytes and platelets count for each participant was estimated throughout the study. Summary data of mean values of leukocytes and platelets count at Baseline and Week 36 are presented.

    Measured: Baseline and Week 36

  11. Mean Values of Creatinine, Potassium, Phosphate, Parathyroid Hormone , Iron and Total Iron Binding Capacity Parameters at Baseline and Week 36

    Mean values of laboratory parameters: creatinine, potassium, phosphate, parathyroid hormone (PTH), iron and total iron binding capacity (TIBC) for each participant were estimated throughout the study. Summary data of mean values of laboratory parameters are presented at Baseline and Week 36.

    Measured: Baseline and Week 36

  12. Mean Values of Albumin and Transferrin Concentration at Baseline and Week 36

    The mean values of albumin and transferrin concentration for each participant throughout the study was estimated. Summary data of mean values of albumin and transferrin concentration at baseline and week 36 are presented.

    Measured: Baseline and Week 36

  13. Mean Values of Ferritin Concentration at Baseline and Week 36

    Mean values of ferritin concentration for each participant throughout the study was estimated. Summary data of mean values of ferritin concentration at Baseline and Week 36 are presented.

    Measured: Baseline and Week 36

  14. Mean Values of Transferrin Saturation at Baseline and Week 36

    The mean values of transferrin saturation (TS) for each participant were estimated throughout the study. Summary data of mean values of TS at Baseline and Week 36 are presented.

    Measured: Baseline and Week 36

  15. Mean Values of Aspartate Transaminase and Alkaline Phosphatase at Baseline and Week 36

    The mean values of aspartate transaminase (AST) and alkaline phosphatase (ALP) levels in serum for each participant were estimated throughout the study. Summary data of mean values of Potassium and alkaline phosphatase level in serum at Baseline and Week 36 are presented.

    Measured: Baseline and Week 36

  16. Number of Participants With Adverse Events and Serious Adverse Events

    An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. 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. Number of participants with at least one AE and SAE were reported.

    Measured: Up to Week 40

  17. Number of Participants With Abnormal Changes in ECG From Baseline to Week 40

    Twelve-lead ECG was performed.

    Measured: From Baseline to Week 40

  18. Number of Participants With Abnormal Changes in Vital Signs From Baseline to Week 40

    Vital signs included blood pressure, pulse rate and body weight.

    Measured: From Baseline to Week 40

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2007 (estimated)
  2. Study startApr 2008
  3. Primary completionDec 2010
  4. Study completionDec 2010

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
233 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00560404
Sponsor's protocol ID
ML21208
Status last verified
Aug 2025
First submitted
16 Nov 2007
Last updated
11 Sep 2025

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing methoxy polyethylene glycol-epoetin beta [Mircera] and Epoetin alfa in people with Anemia, run by Hoffmann-La Roche at 26 sites in Brazil.

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 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Brazil. 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 12 Apr 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 Their Mean Hemoglobin Concentration Within Plus or Minus 1 Gram/Deciliter of Their Reference Hemoglobin and Between the Target Range During Efficacy Evaluation Period (time frame: EEP (Week 29 to Week 36)). 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 NCT00560404, 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 11 Sep 2025.

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