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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00413894

Purpose

This single arm study will assess the efficacy and safety of intravenous Mircera, administered with pre-filled syringes, for the treatment of anemia in patients with chronic kidney disease who are on dialysis, and who have previously received treatment with epoetin alfa or beta or darbepoetin alfa. Patients will receive monthly intravenous injections of Mircera, with the starting dose derived from the dose of epoetin alfa or beta or darbepoetin they were receiving in the week preceding study start. 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]	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open Label Study of the Effect of Intravenous Mircera on Hemoglobin Levels in Anemic Patients With Chronic Kidney Disease Who Are on Dialysis, and Who Have Previously Received Epoetin Alfa or Beta or Darbepoetin Alfa Treatment.

Resource links provided by NLM:

MedlinePlus related topics: Anemia

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

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Percentage of patients in a defined Hb range and percentage of patients with or without dose adjustments, during evaluation period. [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of patients in a defined Hb range, and percentage of patients with or without dose adjustments. [ Time Frame: During screening period ] [ Designated as safety issue: No ]
Incidence of RBC transfusions [ Time Frame: Weeks 0-24 ] [ Designated as safety issue: No ]
AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	661
Study Completion Date:	April 2009

Arms	Assigned Interventions
1: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] iv monthly, with starting dose based on previous dose of epoetin alfa or beta or darbepoetin alfa

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;
longterm hemodialysis for >=12 weeks before screening;
baseline Hb between 10 and 13g/dL;
iv or sc maintenance epoetin alfa or beta or darbepoetin alfa therapy with same dosing interval for >=4 weeks before screening.

Exclusion Criteria:

acute or chronic bleeding within 8 weeks prior to screening;
transfusion of red blood cells within 8 weeks prior to screening;
poorly controlled hypertension necessitating interruption of erythropoetin treatment in previous 6 months;
previous treatment with Mircera.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413894

Show 104 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

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML20572
Study First Received:	December 19, 2006
Last Updated:	July 15, 2009
ClinicalTrials.gov Identifier:	NCT00413894 History of Changes
Health Authority:	Germany: Ethics Commission

Study placed in the following topic categories:

Epoetin Alfa
Hematinics
Hematologic Diseases
Renal Insufficiency, Chronic

Darbepoetin alfa
Anemia
Kidney Failure, Chronic
Kidney Diseases

Additional relevant MeSH terms:

Hematinics
Hematologic Diseases
Therapeutic Uses
Hematologic Agents

Darbepoetin alfa
Anemia
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009