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

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00077610

Purpose

This study will assess the efficacy and safety of intravenous Mircera, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv epoetin. 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: methoxy polyethylene-glycol epoetin beta [Mircera] Drug: epoetin alfa or beta	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open-Label Study of the Effect of Maintenance Intravenous Mircera on Hemoglobin Level/Correction in Patients With Chronic Kidney Disease

Resource links provided by NLM:

MedlinePlus related topics: Anemia

Drug Information available for: Erythropoietin Ethanol, 2,2'-(oxybis(2,1-ethanediyloxy)bis- Epoetin alfa Epoetin beta

U.S. FDA Resources

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 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:	673
Study Completion Date:	April 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: Experimental	Drug: methoxy polyethylene-glycol epoetin beta [Mircera] 30, 50 or 90 micrograms iv (starting dose) every 4 weeks
3: Active Comparator	Drug: epoetin alfa or beta iv 3 times weekly, 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 IV epoetin 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: NCT00077610

Show 100 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Levin NW, Fishbane S, Canedo FV, Zeig S, Nassar GM, Moran JE, Villa G, Beyer U, Oguey D; MAXIMA study investigators. Intravenous methoxy polyethylene glycol-epoetin beta for haemoglobin control in patients with chronic kidney disease who are on dialysis: a randomised non-inferiority trial (MAXIMA). Lancet. 2007 Oct 20;370(9596):1415-21.

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BA16739
Study First Received:	February 10, 2004
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00077610 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Epoetin Alfa
Hematinics
Hematologic Diseases
Therapeutic Uses

Hematologic Agents
Anemia
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010