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A Study of Once Monthly Subcutaneous Mircera in Dialysis Patients With Chronic Renal Anemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00882713
First received: February 17, 2009
Last updated: September 19, 2012
Last verified: September 2012
History of Changes
  Purpose

This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia.Patients will receive subcutaneous Mircera at a starting dose of 120 or 200 micrograms every 4 weeks, calculated from the last weekly dose of epoetin or darbepoetin alfa previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. 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]
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once- Monthly Administration of Subcutaneous CERA for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anemia

Resource links provided by NLM:

MedlinePlus related topics: Anemia Dialysis
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Proportion of patients maintaining average Hb concentration within target range during Efficacy Evaluation period (EEP) [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in hemoglobin concentration between reference (SVP) and the EEP [ Time Frame: Weeks 1-24 ] [ Designated as safety issue: No ]
  • Proportion of patients maintaining hemoglobin concentration within the hemoglobin range 10.5-12.5g/dL throughout the EEP [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
  • Mean time spent in hemoglobin range of 10.5-12.5g/dL [ Time Frame: Every 2 weeks ] [ Designated as safety issue: No ]
  • Adverse events, laboratory parameters [ Time Frame: At planned visits, to week 48 ] [ Designated as safety issue: No ]

Enrollment: 202
Study Start Date: February 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Subcutaneous injection every 4 weeks (starting dose of 120 or 200 micrograms, based on previous ESA therapy)

  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 long-term hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months;
  • continuous iv maintenance epoetin alfa therapy with same dosing interval during previous 2 months.

Exclusion Criteria:

  • transfusion of red blood cells during previous 2 months;
  • poorly controlled hypertension;
  • significant 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: NCT00882713

Locations
Morocco
Agadir, Morocco, 70000
Beni Mellal, Morocco, 23000
Casablanca, Morocco, 20000
Casablanca, Morocco, 20100
FÉS, Morocco, 30000
Marrakech, Morocco, 40000
Méknés, Morocco, 50300
Rabat, Morocco, 62001
Rabat, Morocco, 10150
Salé, Morocco, 15045
Tanger, Morocco, 90000
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: NCT00882713     History of Changes
Other Study ID Numbers: ML21797
Study First Received: February 17, 2009
Last Updated: September 19, 2012
Health Authority: Morocco: Ministry of Public Health

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013