STABIL Study: National Study With Mircera for Maintenance of Hemoglobin Level in Dialysis Patients - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00642850

Purpose

This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients will receive monthly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms, according to the dose of epoetin administered in the week preceding first study drug administration. 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 III

MedlinePlus related topics: Anemia

Drug Information available for: Epoetin beta

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	MIRCEA in ESRD A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-Monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

% patients maintaining average Hb conc. within the target range during the Efficacy Evaluation Period (EEP) [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Hb conc. [ Time Frame: Between reference and EEP ] [ Designated as safety issue: No ]
% patients maintaining Hb within target range [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
% patients requiring dose adjustments; incidence of RBC transfusions [ Time Frame: Weeks 1-24 ] [ Designated as safety issue: No ]
AEs, lab parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	November 2007
Estimated Study Completion Date:	July 2009

Arms	Assigned Interventions
1: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] 120, 200 or 360 micrograms iv monthly (starting dose)

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;
continuous stable iv maintenance epoetin therapy during previous month;
regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.

Exclusion Criteria:

transfusion of red blood cells during previous 2 months;
poorly controlled hypertension requiring hospitalization or interruption of erythropoietin treatment in previous 6 months;
significant acute or chronic bleeding.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642850

Locations

Czech Republic

PISEK, Czech Republic, 397 23

TABOR, Czech Republic, 390 03

STRAKONICE, Czech Republic, 38629

HAVIROV, Czech Republic, 736 24

CESKY KRUMLOV, Czech Republic, 38127

ZNOJMO, Czech Republic, 76275

LIBEREC, Czech Republic, 460 63

PRAHA, Czech Republic, 14000

OSTRAVA, Czech Republic, 708 52

BRNO, Czech Republic, 656 91

USTI NAD LABEM, Czech Republic, 401 13

NOVY JICIN, Czech Republic, 741 11

KOLIN III, Czech Republic, 280 20

SUMPERK, Czech Republic, 787 01

TEPLICE, Czech Republic, 415 01

OLOMOUC, Czech Republic, 775 20

HRADEC KRALOVE, Czech Republic, 500 05

JIHLAVA, Czech Republic, 586 33

KARLOVY VARY, Czech Republic, 360 73

TREBIC, Czech Republic, 674 01

DECIN, Czech Republic, 405 99

PRAHA, Czech Republic, 150 30

PRAHA, Czech Republic, 128 08

PRAHA, Czech Republic, 169 00

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:	ML21040
Study First Received:	March 19, 2008
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00642850 History of Changes
Health Authority:	Czech Republic:SUKL

Study placed in the following topic categories:

Epoetin Alfa
Hematologic Diseases
Anemia

Additional relevant MeSH terms:

Hematologic Diseases
Anemia

ClinicalTrials.gov processed this record on May 07, 2009