A Study of Intravenous (iv) Mircera in Hemodialysis Patients With Chronic Renal Anemia - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00048035

Purpose

This study will determine the appropriate dose and frequency of administration of iv Mircera maintenance therapy in hemodialysis patients with chronic renal anemia who were previously receiving iv epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.

Condition	Intervention	Phase
Anemia	Drug: methoxy polyethylene glycol-epoetin beta [Mircera]	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Open-Label Study of Dose Conversion Factors for Maintenance Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia

Resource links provided by NLM:

MedlinePlus related topics: Anemia Dialysis

Drug Information available for: Epoetin beta

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Change in hemoglobin from baseline over time under constant dosing regimen [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in hematocrit from baseline over time under constant dosing regimen. Vital signs, adverse events, laboratory values [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	91
Study Completion Date:	December 2005

Arms	Assigned Interventions
Experimental: 1	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Differing doses and frequencies of iv administration
Experimental: 2	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Differing doses and frequencies of iv administration
Experimental: 3	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Differing doses and frequencies of iv administration
Experimental: 4	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Differing doses and frequencies of iv administration
Experimental: 5	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Differing doses and frequencies of iv administration
Experimental: 6	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Differing doses and frequencies of iv administration

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 hemodialysis therapy for at least 3 months;
receiving iv epoetin alfa during the 2 weeks prior to the run-in period.

Exclusion Criteria:

women who are pregnant, breastfeeding or using unreliable birth control methods;
use of any investigational drug within 30 days of the run-in phase, or during the run-in or study treatment period.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048035

Locations

United States, Alabama

Birmingham, Alabama, United States, 35211
United States, California

Los Angeles, California, United States, 90095
United States, Illinois

Maywood, Illinois, United States, 60153
United States, Kentucky

Louisville, Kentucky, United States, 40202-1718
United States, Michigan

Detroit, Michigan, United States, 48236

Detroit, Michigan, United States, 48202-2689
United States, Minnesota

Brooklyn Center, Minnesota, United States, 55430
United States, Nevada

Las Vegas, Nevada, United States, 89106
United States, New Jersey

Paterson, New Jersey, United States, 07503
United States, New York

Brooklyn, New York, United States, 11203

Mineola, New York, United States, 11501

New York, New York, United States, 10128
United States, Tennessee

Nashville, Tennessee, United States, 37232
United States, West Virginia

Morgantown, West Virginia, United States, 26506

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00048035 History of Changes
Other Study ID Numbers:	BA16285
Study First Received:	October 24, 2002
Last Updated:	May 13, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on February 09, 2012