A Study of Intravenous Mircera for the Maintenance Treatment of Hemodialysis Patients With Chronic Renal Anemia - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00605293

Purpose

This 2 arm study will compare the efficacy and safety of monthly administration of intravenous Mircera versus epoetin alfa for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Patients currently receiving maintenance treatment with epoetin alfa will be randomized either to receive monthly injections of 120, 200 or 360 micrograms Mircera, with the starting dose derived from the dose of epoetin alfa they were receiving in the week preceding study start, or to continue on epoetin alfa treatment. 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 alfa	Phase III

MedlinePlus related topics: Anemia Dialysis Kidney Failure

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:	An Open Label Randomised Controlled Study to Compare the Efficacy, Safety and Tolerability of Once-Monthly Administration of Intravenous C.E.R.A. Versus Epoetin Alfa 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:

Percentage of patients maintaining average Hb concentration within +/- 1g/dL of reference Hb, and between 10-12g/dL during evaluation period. [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Hb concentration, and percentage of patients maintaining Hb concentration in 10-12g/dL range. [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
Mean time in 10-12g/dL range; percentage of patients needing dose adjustments; incidence of RBC transfusions. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	297
Study Start Date:	February 2008
Estimated Study Completion Date:	January 2010

Arms	Assigned Interventions
1: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] 120, 200 or 360 micrograms iv/month (starting dose)
2: Active Comparator	Drug: Epoetin alfa 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;
continuous iv maintenance epoetin alfa therapy, with the same dosing interval during the 2 months before screening;
regular hemodialysis for >=3 months.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605293

Contacts

Contact: Please reference Study ID Number: ML21060	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

Spain
	Recruiting
MADRID, Spain, 28041
	Recruiting
VALENCIA, Spain, 46009
	Recruiting
ZARAGOZA, Spain, 50009
	Recruiting
SALAMANCA, Spain, 37008
	Recruiting
BARCELONA, Spain, 08035
	Recruiting
VALENCIA, Spain, 46010
	Recruiting
HUELVA, Spain, 21005
	Recruiting
CIUDAD REAL, Spain, 13005
	Recruiting
MADRID, Spain, 28034
	Recruiting
MADRID, Spain, 28905
	Recruiting
MARBELLA, Spain, 296000
	Recruiting
CASTELLON, Spain, 12004
	Recruiting
BADAJOZ, Spain, 06300
	Recruiting
PONTEVEDRA, Spain, 36071
	Recruiting
ZAMORA, Spain, 49022
	Recruiting
TERUEL, Spain, 444600
	Recruiting
TUDELA, Spain, 46010
	Recruiting
CACERES, Spain, 10310

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML21060
Study First Received:	January 18, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00605293
Health Authority:	Spain: Sanitarios

Study placed in the following topic categories:

Epoetin Alfa
Hematologic Diseases
Anemia

Additional relevant MeSH terms:

Hematinics
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009