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A Study of Once-Monthly Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia.

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ClinicalTrials.gov Identifier: NCT00560547
Recruitment Status : Withdrawn (The study was cancelled before any patients were enrolled, due to operational reasons.)
First Posted : November 19, 2007
Last Update Posted : August 24, 2016
Information provided by:
Hoffmann-La Roche

Brief Summary:
This single arm study will assess the long-term maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in hemodialysis patients with chronic renal anemia. Patients currently receiving darboepoetin alfa or epoetin alfa maintenance treatment will receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/4 weeks (based on the ESA dose administered on week-1). Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10.5-12.5g/dL. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Condition or disease Intervention/treatment Phase
Anemia Drug: methoxy polyethylene glycol-epoetin beta Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study to Assess the Maintenance of Hemoglobin Levels, Safety and Tolerability of Once Monthly Administration of Mircera in Hemodialysis Patients With Chronic Renal Anemia.
Study Start Date : October 2007
Estimated Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta
120, 200 or 360 micrograms / 4 weeks iv (starting dose)
Other Name: Mircera

Primary Outcome Measures :
  1. Percentage of patients maintaining average Hb concentration within target range during evaluation period [ Time Frame: Weeks 17-24 ]

Secondary Outcome Measures :
  1. Change in Hb concentration between reference and evaluation period; mean time spent in, and percentage of patients maintaining Hb within target range [ Time Frame: Weeks 17-24 ]
  2. Dose adjustments; RBC transfusions [ Time Frame: Throughout study ]
  3. AEs, laboratory parameters, vital signs [ Time Frame: Throughout study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • chronic renal anemia;
  • regular long-term hemodialysis therapy with the same mode of dialysis for >=3 months;
  • continuous iv or sc maintenance ESA treatment during previous 2 months.

Exclusion Criteria:

  • transfusion of red blood cells during previous 2 months;
  • significant acute or chronic bleeding, such as overt gastrointestinal bleeding;
  • active malignant disease (except non-melanoma skin cancer).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00560547

Aalborg, Denmark, 9100
Fredericia, Denmark, 7000
Roskilde, Denmark, 4000
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00560547     History of Changes
Other Study ID Numbers: ML21349
First Posted: November 19, 2007    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Hematologic Diseases