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

Purpose

This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently receiving epoetin or any other erythropoietic substance. 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: epoetin	Phase III

MedlinePlus related topics:

Anemia

ChemIDplus related topics:

Epoetin alfa Erythropoietin Epoetin beta

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 Intravenous Mircera on Hemoglobin Level/Correction in Dialysis Patients With Chronic Kidney Disease

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Hemoglobin response rate [ Time Frame: Weeks 1-24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hb over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, AEs, laboratory values [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	182
Study Completion Date:	June 2006

Arms	Assigned Interventions
1: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] 0.4 micrograms/kg iv (starting dose) once every 2 weeks
2: Active Comparator	Drug: epoetin 3 times a week iv, 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;
dialysis therapy for at least 2 weeks before screening.

Exclusion Criteria:

women who are pregnant, breastfeeding or using unreliable birth control methods;
administration of any investigational drug within 4 weeks before screening.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077597

Show 40 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:

Klinger M, Arias M, Vargemezis V, Besarab A, Sulowicz W, Gerntholtz T, Ciechanowski K, Dougherty FC, Beyer U. Efficacy of intravenous methoxy polyethylene glycol-epoetin beta administered every 2 weeks compared with epoetin administered 3 times weekly in patients treated by hemodialysis or peritoneal dialysis: a randomized trial. Am J Kidney Dis. 2007 Dec;50(6):989-1000.

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BA16736
First Received:	February 10, 2004
Last Updated:	August 18, 2008
ClinicalTrials.gov Identifier:	NCT00077597
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Epoetin Alfa

Hematologic Diseases

Anemia

Kidney Failure, Chronic

Kidney Diseases

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00077597