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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00546481

Purpose

This 2 arm study will evaluate the efficacy of intravenous Mircera treatment for the correction of anemia in patients with chronic kidney disease who are on dialysis. Patients will be randomized to receive either Mircera 0.6 micrograms/kg i.v. every 2 weeks, or epoetin 3 times per week i.v. according to approved treatment recommendations. 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: Epoetin	Phase III

MedlinePlus related topics: Anemia

Drug Information available for: Erythropoietin Epoetin alfa Epoetin beta

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 of the Effect of Intravenous Mircera on the Hemoglobin Response Rate in Patients With Chronic Kidney Disease Who Are on Dialysis.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Hb response rate (increase in Hb >=1g/dL, and Hb concentration >=11g/dL, without RBC transfusion) [ Time Frame: Weeks 0-24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hb values, change from baseline, time to Hb response [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Incidence of RBC transfusions [ Time Frame: Weeks 0-24 ] [ Designated as safety issue: No ]
AEs, laboratory parameters, vital signs, ECGs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	104
Study Start Date:	November 2007
Estimated Study Completion Date:	August 2009

Arms	Assigned Interventions
1: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] 0.6 micrograms/kg every 2 weeks
2: Active Comparator	Drug: Epoetin As prescribed, iv, 3 times weekly

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;
maintenance hemodialysis or peritoneal dialysis for >=2 weeks before screening, and during screening period.

Exclusion Criteria:

previous therapy with epoetin within 8 weeks prior to screening;
overt gastrointestinal bleeding within 8 weeks before screening or during screening period;
RBC transfusions within 8 weeks before screening or during screening period;
active malignant disease except non-melanoma skin cancer.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546481

Locations

Korea, Republic of

SEOUL, Korea, Republic of, 135-710

SEOUL, Korea, Republic of, 110-744

SUNGNAM, Korea, Republic of, 463-802

KYUNGGI-DO, Korea, Republic of, 431-070

Seoul, Korea, Republic of, 137-807

SEOUL, Korea, Republic of, 405-760

SEOUL, Korea, Republic of, 134-701

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:	ML20884
Study First Received:	October 18, 2007
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00546481 History of Changes
Health Authority:	Korea: KFDA

Study placed in the following topic categories:

Epoetin Alfa
Hematologic Diseases
Renal Insufficiency, Chronic

Anemia
Kidney Failure, Chronic
Kidney Diseases

Additional relevant MeSH terms:

Hematologic Diseases
Anemia

ClinicalTrials.gov processed this record on May 07, 2009