A Study of Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Predialysis Patients Not Treated With ESA.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00661388
First received: April 16, 2008
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

This single arm study will assess the efficacy and safety of subcutaneous Mircera for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with ESA. Eligible patients will receive monthly subcutaneous injections of Mircera at an initial recommended dose of 1.2 micrograms/kg. 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: An Open Label Study of the Safety, Tolerability and Effect on Hemoglobin Levels of Monthly Subcutaneous Mircera in Predialysis Patients With Chronic Renal Anemia Not Currently Treated With ESA.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Mean change in Hb concentration between baseline and Efficacy Evaluation Period (EEP) [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to achievement of response [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Percentage of patients whose Hb concentration remains within range 10.0-12.0 g/dL [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]
  • Percentage of patients whose average Hb concentration is within range 10.0-12.0 g/dL [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]
  • Mean time spent in Hb range of 10.0-12.0 g/dL [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]
  • Percentage of patients requiring dose adjustments; incidence of RBC transfusions. [ Time Frame: Weeks 0-36 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: August 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
sc every month (starting dose 1.2 micrograms/kg)

  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;
  • predialysis stage;
  • no ESA therapy during previous 3 months.

Exclusion Criteria:

  • transfusion of red blood cells during previous 2 months;
  • poorly controlled hypertension requiring hospitalization 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: NCT00661388

Locations
Turkey
Ankara, Turkey, 06100
Denizli, Turkey, 20100
Edirne, Turkey, 22030
Istanbul, Turkey, 34381
Istanbul, Turkey, 34377
Istanbul, Turkey, 34390
Istanbul, Turkey, 34000
Kahramanmaras, Turkey, 46100
Konya, Turkey, 42770
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: NCT00661388     History of Changes
Other Study ID Numbers: ML21524
Study First Received: April 16, 2008
Last Updated: July 1, 2013
Health Authority: Turkey: Ministry of Health

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on August 01, 2014