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OpenTrials
Completed

NCT Number: NCT00560404

A Study of Subcutaneous Mircera for the Maintenance Treatment of 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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Belo Horizonte, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

methoxy polyethylene glycol-epoetin beta [Mircera]

Drug

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

Epoetin alfa

Drug

As prescribed

Primary outcomes

  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

    Time frame: EEP (Week 29 to Week 36)

    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.

Secondary outcomes

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

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

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

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

    Time frame: EEP (Weeks 29 to 36)

    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.

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

    Time frame: EEP (Week 29 to Week 36)

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

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

    Time frame: DTP (Weeks 0 to 28)

    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.

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

    Time frame: EEP (Weeks 29 to 36)

    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.

  6. Number of Participants Received Red Blood Cells Transfusions

    Time frame: Up to Week 28

    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.

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

    Time frame: 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.

  8. Mean Values of Hematocrit at Baseline and Week 36

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: Up to Week 40

    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.

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

    Time frame: From Baseline to Week 40

    Twelve-lead ECG was performed.

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

    Time frame: From Baseline to Week 40

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 19, 2007
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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