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This study has been withdrawn prior to enrollment.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:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00560547
First received: November 16, 2007
Last updated: February 15, 2008
Last verified: February 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Dose adjustments; RBC transfusions [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, vital signs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
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

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 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
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: 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

No publications provided

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00560547     History of Changes
Other Study ID Numbers: ML21349
Study First Received: November 16, 2007
Last Updated: February 15, 2008
Health Authority: Denmark: Laegemiddelstyrelsen (DMA)

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on July 24, 2014