A Study of Mircera for the Maintenance Treatment of Anemia in Dialysis Patients. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00394953

Purpose

This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa, administered at extended dosing intervals, in the maintenance treatment of anemia in patients with chronic kidney disease who are on hemodialysis. Eligible patients receiving once-weekly intravenous darbepoetin alfa maintenance treatment will be randomized to receive either intravenous Mircera once a month (at a starting dose of 120, 200 or 360 micrograms/month, depending on the weekly dose of darbepoetin alfa prior to start of study) or intravenous darbepoetin alfa every 2 weeks before switching to once monthly administration. 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 [Mircera] Drug: Darbepoetin alfa	Phase III

MedlinePlus related topics: Anemia Dialysis

Drug Information available for: Epoetin alfa Erythropoietin Epoetin beta Darbepoetin alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open Label Study to Compare the Effect of Mircera With That of Darbepoetin Alfa, Administered Intravenously at Extended Dosing Intervals, for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Hemodialysis.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Percentage of patients with average Hb decrease from baseline <=1.0g/dL, and an average Hb >=10.5g/dL [ Time Frame: Weeks 50 - 53 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in dose over time [ Time Frame: Week 27 to months 11 and 12 ] [ Designated as safety issue: No ]
AEs, laboratory parameters, vital signs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	488
Study Start Date:	January 2007
Estimated Study Completion Date:	December 2008

Arms	Assigned Interventions
1: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] 120, 200 or 360 micrograms iv / month, starting dose
2: Active Comparator	Drug: Darbepoetin alfa As prescribed, iv.

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;
hemodialysis 3 times weekly for >=12 weeks before screening, and during screening/baseline period;
receiving darbepoetin alfa maintenance therapy for >=8 weeks before screening, and during screening/baseline period.

Exclusion Criteria:

overt gastrointestinal bleeding within 8 weeks before screening or during screening/baseline period;
transfusion of red blood cells within 8 weeks before screening or during screening/baseline period;
active malignancy;

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394953

Show 88 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BH17847
Study First Received:	November 1, 2006
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00394953
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Epoetin Alfa
Hematologic Diseases
Renal Insufficiency, Chronic
Darbepoetin alfa

Anemia
Kidney Failure, Chronic
Kidney Diseases

Additional relevant MeSH terms:

Hematinics
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009