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

Purpose

This study will assess the efficacy and safety of intravenous (iv) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv darbepoetin alfa. The anticipated time on study treatment is 1-2 years 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

Drug Information available for:

Epoetin alfa Erythropoietin Epoetin beta Darbepoetin alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Randomized Open-Label Study of the Effect of Maintenance Intravenous Mircera on Hemoglobin Levels in Anemic Dialysis Patients With Chronic Kidney Disease

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Change in hemoglobin concentration [ Time Frame: Weeks 1-36 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of patients maintaining average Hb concentration within +/- 1g/dL of average baseline Hb concentration [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]
RBC transfusions [ Time Frame: Weeks 1-36 ] [ Designated as safety issue: No ]
AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	313
Study Completion Date:	February 2006

Arms	Assigned Interventions
1: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] 30, 50 or 90 micrograms iv (starting dose) every 2 weeks
2: Active Comparator	Drug: Darbepoetin alfa iv weekly, every 2 weeks, 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;
chronic renal anemia;
on dialysis therapy for at least 12 weeks before screening;
receiving darbepoetin alfa iv for at least 8 weeks before screening.

Exclusion Criteria:

women who are pregnant, breastfeeding or using unreliable birth control methods;
administration of another investigational drug within 4 weeks before screening, or during the study period.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077766

Show 47 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche, +1 973 235 5000

More Information

Publications indexed to this study:

Canaud B, Mingardi G, Braun J, Aljama P, Kerr PG, Locatelli F, Villa G, Van Vlem B, McMahon AW, Kerloëguen C, Beyer U; STRIATA Study Investigators. Intravenous C.E.R.A. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study. Nephrol Dial Transplant. 2008 Nov;23(11):3654-61. Epub 2008 Jun 27.

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BA17283
First Received:	February 12, 2004
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00077766
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Epoetin Alfa

Hematologic Diseases

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 November 30, 2008

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00077766