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

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.

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]; Drug: Epoetin alfa

• Study Type: Interventional
• Enrollment (Actual): 233
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Belo Horizonte, Brazil, 30150-320
  • Brasília, Brazil, 70390-108
  • Campinas, Brazil, 13086-970
  • Campo Grande, Brazil, 79002-073
  • Cariacica, Brazil, 29152-230
  • Curitiba, Brazil, 80050-350
  • Curitiba, Brazil, 80440-020
  • Fortaleza, Brazil, 60430160
  • Jaboatão dos Guararapes, Brazil, 54400-170
  • Joinville, Brazil, 89227-680
  • Juiz de Fora, Brazil, 36036900
  • Londrina, Brazil, 86015-000
  • Natal, Brazil, 59020-110
  • Porto Alegre, Brazil, 90035-903
  • Porto Alegre, Brazil, 90610000
  • Ribeirão Preto, Brazil, 14025-170
  • Rio de Janeiro, Brazil
  • Salvador, Brazil, 40110-060
  • Sorocaba, Brazil, 18030-210
  • São José do Rio Preto, Brazil, 15090-000
  • São Luís, Brazil, 65020-305
  • São Paulo, Brazil, 01246-903
  • São Paulo, Brazil, 01323-900
  • São Paulo, Brazil, 01532-001
  • São Paulo, Brazil, 03065-000
  • São Paulo, Brazil, O4023

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: methoxy polyethylene glycol-epoetin beta [Mircera]; 120, 200 or 360 micrograms sc monthly (starting dose)
Active Comparator: 2	Drug: Epoetin alfa; As prescribed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	EEP (Week 29 to Week 36)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Weeks -4 to 0) and at EEP (Weeks 29 to 36)
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.	EEP (Weeks 29 to 36)
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.	EEP (Week 29 to Week 36)
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.	DTP (Weeks 0 to 28)
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.	EEP (Weeks 29 to 36)
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.	Up to Week 28
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.	Baseline and Week 36
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.	Baseline and Week 36
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.	Baseline and Week 36
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.	Baseline and Week 36
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.	Baseline and Week 36
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.	Baseline and Week 36
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.	Baseline and Week 36
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.	Baseline and Week 36
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.	Baseline and Week 36
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.	Up to Week 40
Number of Participants With Abnormal Changes in ECG From Baseline to Week 40	Twelve-lead ECG was performed.	From Baseline to Week 40
Number of Participants With Abnormal Changes in Vital Signs From Baseline to Week 40	Vital signs included blood pressure, pulse rate and body weight.	From Baseline to Week 40

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: November 16, 2007
• First Submitted That Met QC Criteria: November 16, 2007
• First Posted (Estimated): November 19, 2007

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Carbohydrates; Intercellular Signaling Peptides and Proteins; Glycoproteins; Glycoconjugates; Colony-Stimulating Factors; Hematopoietic Cell Growth Factors; Cytokines; Erythropoietin; Epoetin Alfa; continuous erythropoietin receptor activator
• Other Study ID Numbers: ML21208