A Study of Once-Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Pre-Dialysis Patients Not Currently Treated With ESA. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00680563

Purpose

This single arm study will assess the efficacy and safety of subcutaneous Mircera for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with ESA. Eligible patients will receive monthly subcutaneous injections at an initial recommended dose of 1.2 micrograms/kg. 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]	Phase III

MedlinePlus related topics: Anemia

Drug Information available for: Epoetin alfa Erythropoietin Epoetin beta

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open Label Study of the Safety, Tolerability and Effect on Hemoglobin Levels of Once-Monthly Subcutaneous Mircera in Predialysis Patients With Chronic Renal Anemia Not Currently Treated With ESA.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Mean change in Hb concentration between baseline and Efficacy Evaluation Period (EEP). [ Time Frame: Week 32 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to achievement of response [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Percentage of patients whose Hb concentration remains within range 10.0-12.0g/dL [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Percentage of patients whose average Hb concentration is within range 10.0 - 12.0g/dL [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Mean time spent in Hb range of 10.0 - 12.0g/dL [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Percentage of patients requiring dose adjustments; incidence of RBC transfusions; time to initiation of renal replacement therapy. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	280
Study Start Date:	October 2008
Estimated Study Completion Date:	December 2010

Arms	Assigned Interventions
1: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] sc every month (starting dose 1.2 micrograms/kg)

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;
no ESA therapy during previous 3 months;
adequate iron status;
rapid chronic kidney disease progression.

Exclusion Criteria:

transfusion of red blood cells during previous 2 months;
poorly controlled hypertension requiring hospitalization in previous 6 months;
significant acute or chronic bleeding.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680563

Contacts

Contact: Please reference Study ID Number: ML21467	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Show 41 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:	ML21467
Study First Received:	May 16, 2008
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00680563
Health Authority:	Brazil: Ministry of Health

Study placed in the following topic categories:

Epoetin Alfa
Hematologic Diseases
Anemia

ClinicalTrials.gov processed this record on January 16, 2009