A Study of Intravenous Mircera for the Maintenance Treatment of Hemodialysis Patients With Chronic Renal Anemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00605293
First received: January 18, 2008
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

This 2 arm study will compare the efficacy and safety of monthly administration of intravenous Mircera versus epoetin alfa for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Patients currently receiving maintenance treatment with epoetin alfa will be randomized either to receive monthly injections of 120, 200 or 360 micrograms Mircera, with the starting dose 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: An Open Label Randomised Controlled Study to Compare the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. Versus Epoetin Alfa for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia

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 +/- 1g/dL of reference Hb, and between 10-12g/dL during evaluation period. [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Hb concentration, and percentage of patients maintaining Hb concentration in 10-12g/dL range. [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
  • Mean time in 10-12g/dL range; percentage of patients needing dose adjustments; 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: 101
Study Start Date: December 2007
Study Completion Date: February 2010
Primary Completion Date: February 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 iv/month (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;
  • continuous iv maintenance epoetin alfa therapy, with the same dosing interval during the 2 months before screening;
  • regular hemodialysis for >=3 months.

Exclusion Criteria:

  • transfusion of red blood cells during previous 2 months;
  • poorly controlled hypertension requiring interruption of epoetin alfa treatment in previous 6 months;
  • significant acute or chronic bleeding.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605293

Locations
Spain
Cádizv, Cadiz, Spain, 11008
Marbella, Malaga, Spain, 29603
Tudela, Navarra, Spain, 46010
Badajoz, Spain, 06300
Barcelona, Spain, 08035
Caceres, Spain, 10310
Castellon, Spain, 12004
Ciudad Real, Spain, 13005
Huelva, Spain, 21005
Madrid, Spain, 28041
Madrid, Spain, 28905
Madrid, Spain, 28034
Pontevedra, Spain, 36071
Salamanca, Spain, 37008
Teruel, Spain, 44003
Valencia, Spain, 46009
Valencia, Spain, 46010
Zamora, Spain, 49022
Zaragoza, Spain, 50009
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00605293     History of Changes
Other Study ID Numbers: ML21060
Study First Received: January 18, 2008
Last Updated: October 7, 2013
Health Authority: Spain: Sanitarios

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

ClinicalTrials.gov processed this record on August 21, 2014