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

NCT00560404 | Completed Phase 3 Results

• 1 other identifier: ML21208
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 26

Brief 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. 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

Outcome Measures

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

  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 Outcomes (18)

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

  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

  EEP (Weeks 29 to 36)

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

  EEP (Week 29 to Week 36)

• Number of Participants Who Required Dose Adjustments During the Dose Titration Period

  DTP (Weeks 0 to 28)

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

  EEP (Weeks 29 to 36)

Study Arms (2)

1

EXPERIMENTAL

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

2

ACTIVE COMPARATOR

Drug: Epoetin alfa

Interventions

methoxy polyethylene glycol-epoetin beta [Mircera] DRUG

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

1

Epoetin alfa DRUG

As prescribed

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (26)

Unknown Facility

Belo Horizonte, 30150-320, Brazil

Location

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Brasília, 70390-108, Brazil

Location

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Campinas, 13086-970, Brazil

Location

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Campo Grande, 79002-073, Brazil

Location

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Cariacica, 29152-230, Brazil

Location

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Curitiba, 80050-350, Brazil

Location

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Curitiba, 80440-020, Brazil

Location

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Fortaleza, 60430160, Brazil

Location

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Jaboatão dos Guararapes, 54400-170, Brazil

Location

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Joinville, 89227-680, Brazil

Location

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Juiz de Fora, 36036900, Brazil

Location

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Londrina, 86015-000, Brazil

Location

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Natal, 59020-110, Brazil

Location

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Porto Alegre, 90035-903, Brazil

Location

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Porto Alegre, 90610000, Brazil

Location

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Ribeirão Preto, 14025-170, Brazil

Location

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Rio de Janeiro, Brazil

Location

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Salvador, 40110-060, Brazil

Location

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São José do Rio Preto, 15090-000, Brazil

Location

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São Luís, 65020-305, Brazil

Location

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São Paulo, 01246-903, Brazil

Location

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São Paulo, 01323-900, Brazil

Location

Unknown Facility

São Paulo, 01532-001, Brazil

Location

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São Paulo, 03065-000, Brazil

Location

Unknown Facility

São Paulo, O4023, Brazil

Location

Unknown Facility

Sorocaba, 18030-210, Brazil

Location

Related Publications (1)

• 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.

  PMID: 26965694 DERIVED

MeSH Terms

Conditions

Anemia

Interventions

continuous erythropoietin receptor activator; Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 61 6878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2007
• First Posted: November 19, 2007
• Study Start: April 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: September 11, 2025
• Results First Posted: April 12, 2016

Record last verified: 2025-08

Locations

BR (26)