Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00717821
First received: July 16, 2008
Last updated: January 17, 2012
Last verified: January 2012
History of Changes
  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:

U.S. FDA Resources

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: September 2008
Estimated Study Completion Date: February 2012
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
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: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00717821     History of Changes
Other Study ID Numbers: ML21145
Study First Received: July 16, 2008
Last Updated: January 17, 2012
Health Authority: France: Agence francaise de securite sanitaire des produits de sante (AFSSAPS)

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

ClinicalTrials.gov processed this record on May 16, 2013