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

This study has been withdrawn prior to enrollment.
(The study was cancelled before any patients were enrolled, due to operational reasons.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00560547
First Posted: November 19, 2007
Last Update Posted: August 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hoffmann-La Roche
  Purpose
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 Intervention Phase
Anemia Drug: methoxy polyethylene glycol-epoetin beta Phase 3

Study Type: Interventional
Study Design: 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.

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 17-24 ]

Secondary Outcome Measures:
  • 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 ]
  • Dose adjustments; RBC transfusions [ Time Frame: Throughout study ]
  • AEs, laboratory parameters, vital signs [ Time Frame: Throughout study ]

Enrollment: 0
Study Start Date: October 2007
Estimated Study Completion Date: October 2009
Arms Assigned Interventions
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta
120, 200 or 360 micrograms / 4 weeks iv (starting dose)
Other Name: Mircera

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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).
  Contacts and Locations
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


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

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00560547     History of Changes
Other Study ID Numbers: ML21349
First Submitted: November 16, 2007
First Posted: November 19, 2007
Last Update Posted: August 24, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Anemia
Hematologic Diseases