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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00717821
First received: July 16, 2008
Last updated: October 7, 2013
Last verified: October 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Dose adjustments, RBC transfusions, AEs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

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

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;
  • 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
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: NCT00717821

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00717821     History of Changes
Other Study ID Numbers: ML21145
Study First Received: July 16, 2008
Last Updated: October 7, 2013
Health Authority: France: Agence francaise de securite sanitaire des produits de sante (AFSSAPS)

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Epoetin alfa
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014