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A Study of Once Monthly Intravenous or Subcutaneous Mircera in Patients With Chronic Kidney Disease on Hemodialysis.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00717821
First Posted: July 18, 2008
Last Update Posted: October 8, 2013
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 (Responsible Party):
Hoffmann-La Roche
  Purpose
This 2 arm study will compare the hemoglobin maintenance with once monthly Mircera administration versus epoetin beta or darbepoetin alfa in patients with chronic kidney disease on hemodialysis. Patients will be randomized to receive either monthly s.c. or i.v. Mircera (at a starting dose of 120 or 200 micrograms, calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered), or standard therapy (iv or sc epoetin beta once, twice or thrice weekly, or iv or sc darbepoetin alfa once a week or twice a week). The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Condition Intervention Phase
Anemia Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Drug: Epoetin beta or darbepoetin alfa Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Open Label, French Multicenter Parallel Group Study to Compare the Hemoglobin Maintenance With Once Monthly Administration of Mircera Versus Epoetin Beta or Darbepoetin Alfa in Patients With Chronic Kidney Disease on Hemodialysis

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 (10-12g/dL) during evaluation period. [ Time Frame: Weeks 16-24 ]

Secondary Outcome Measures:
  • Mean change in Hb concentration between reference and evaluation period, and mean time spent in Hb range of 10-12g/dL during evaluation period. [ Time Frame: Weeks 16-24 ]
  • Dose adjustments, RBC transfusions, AEs. [ Time Frame: Throughout study ]

Enrollment: 421
Study Start Date: October 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
120 micrograms or 200 micrograms iv or sc (starting dose)
Active Comparator: 2 Drug: Epoetin beta or darbepoetin alfa
As prescribed

  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;
  • regular long term hemodialysis with same schedule for >=12 weeks;
  • continuous iv or sc maintenance epoetin beta or darbepoetin alfa therapy, with the same dosing interval during the previous month, and no change in total weekly dose.

Exclusion Criteria:

  • transfusion of red blood cells during previous 2 months;
  • significant acute or chronic bleeding;
  • poorly controlled hypertension requiring hospitalization or interruption of epoetin beta/darbepoetin alfa treatment in previous 6 months;
  • weekly dose of epoetin beta >16000 UI, or weekly dose of darbepoetin alfa >80 micrograms during previous month.
  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): NCT00717821


  Show 90 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00717821     History of Changes
Other Study ID Numbers: ML21145
First Submitted: July 16, 2008
First Posted: July 18, 2008
Last Update Posted: October 8, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Epoetin Alfa
Darbepoetin alfa
Hematinics