A Study of Subcutaneous (sc) Mircera in Dialysis Patients With Chronic Renal Anemia. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00364832

Purpose

This study will determine the appropriate dose and frequency of administration of sc Mircera maintenance therapy in dialysis patients with chronic renal anemia who were previously receiving sc epoetin alfa or beta. 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 II

MedlinePlus related topics: Anemia

Drug Information available for: Epoetin alfa Erythropoietin 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 Dose Conversion Factors for Maintenance Subcutaneous Mircera in Dialysis Patients With Chronic Renal Anemia

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:	137
Study Completion Date:	February 2003

Arms	Assigned Interventions
1: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Differing doses and frequencies of sc administration
2: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Differing doses and frequencies of sc administration
3: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Differing doses and frequencies of sc administration
4: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Differing doses and frequencies of sc administration
5: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Differing doses and frequencies of sc administration
6: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Differing doses and frequencies of sc administration
7: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Differing doses and frequencies of sc administration
8: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Differing doses and frequencies of sc administration
9: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Differing doses and frequencies of sc 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 dialysis (hemodialysis or peritoneal dialysis) therapy for at least 3 months;
receiving sc epoetin alfa or beta for at least 3 months 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 preceding 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: NCT00364832

Locations

United States, California

LOS ANGELES, California, United States, 90073

SAN JOSE, California, United States, 95116-1906
United States, Massachusetts

BOSTON, Massachusetts, United States, 02130
United States, Ohio

CLEVELAND, Ohio, United States, 44106
United States, Texas

HOUSTON, Texas, United States, 77030
United States, West Virginia

MORGANTOWN, West Virginia, United States, 26506
Germany

MANNHEIM, Germany, 68167

WIESLOCH, Germany, 69168

BERLIN, Germany, 10625

VILLINGEN-SCHWENNINGEN, Germany, 78054
Italy

BARI, Italy, 70124

BERGAMO, Italy, 24128

LECCO, Italy, 23900

MILANO, Italy, 20122

PAVIA, Italy, 27100

VICENZA, Italy, 36100

MODENA, Italy, 41100

LODI, Italy, 26900
Spain

MALAGA, Spain, 29010

SANTANDER, Spain, 39008

MADRID, Spain, 28007

MADRID, Spain, 28046

Barcelona, Spain, 08036

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:

Locatelli F, Villa G, de Francisco AL, Albertazzi A, Adrogue HJ, Dougherty FC, Beyer U; BA16286 Study Investigators. Effect of a continuous erythropoietin receptor activator (C.E.R.A.) on stable haemoglobin in patients with CKD on dialysis: once monthly administration. Curr Med Res Opin. 2007 May;23(5):969-79.

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BA16286
Study First Received:	August 15, 2006
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00364832
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Epoetin Alfa
Hematologic Diseases
Anemia

ClinicalTrials.gov processed this record on January 14, 2009