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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This study has been withdrawn prior to enrollment.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:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00560547
First received: November 16, 2007
Last updated: February 15, 2008
Last verified: February 2008

November 16, 2007
February 15, 2008
October 2007
Not Provided
Percentage of patients maintaining average Hb concentration within target range during evaluation period [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
Proportion of patients maintaining average Hb concentration during efficacy evaluation period (EEP) within the target range.
Complete list of historical versions of study NCT00560547 on ClinicalTrials.gov Archive Site
  • 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 ]
Efficacy: Change in Hb concentration between reference and EEP; mean time spent in target range; percentage of patients maintaining Hb within target range; dose adjustments; RBC transfusions. Safety: AEs, laboratory parameters, vital signs.
Not Provided
Not Provided
 
A Study of Once-Monthly Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia.
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Anemia
Drug: methoxy polyethylene glycol-epoetin beta
120, 200 or 360 micrograms / 4 weeks iv (starting dose)
Other Name: Mircera
Experimental: 1
Intervention: Drug: methoxy polyethylene glycol-epoetin beta
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
200
October 2009
Not Provided

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00560547
ML21349
Not Provided
Clinical Trials, Study Director, Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP