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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00560404
First received: November 16, 2007
Last updated: March 15, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Anemia
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Drug: Epoetin alfa
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.¿

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of patients maintaining average Hb concentration within target range during evaluation period [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients maintaining Hb concentration in target range during evaluation period [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]
  • Changes in Hb concentration over evaluation period, and average time elapsed within target range [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]
  • Incidence of RBC transfusions [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 233
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560404

Locations
Brazil
Belo Horizonte, Brazil, 30150-320
Brasilia, 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
Sao Jose Do Rio Preto, Brazil, 15090-000
Sao Luis, Brazil, 65020-305
Sao Paulo, Brazil, 03065-000
Sao Paulo, Brazil, 01323-900
Sao Paulo, Brazil, 01532-001
Sao Paulo, Brazil, 01246-903
Sao Paulo, Brazil, O4023
Sorocaba, Brazil, 18030-210
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00560404     History of Changes
Other Study ID Numbers: ML21208
Study First Received: November 16, 2007
Last Updated: March 15, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014