A Study of Subcutaneous Mircera for the Maintenance Treatment of Patients With Chronic Renal Anemia Not on Dialysis. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00642304

Purpose

This single arm study will assess the efficacy and safety of subcutaneous Mircera when administered for the maintenance of hemoglobin levels in patients with chronic renal anemia, not on dialysis. Patients currently receiving maintenance treatment with subcutaneous darbepoetin alfa or epoetin beta will receive monthly injections of Mircera, with the starting dose (120, 200 or 360 micrograms s.c.) derived from the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding study start. 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:	A Single Arm Open Label Study to Assess Efficacy, Safety and Tolerability of Once-Monthly Administration of Subcutaneously Mircera for the Maintenance of Hemoglobin Levels in Patients With Chronic Renal Anemia Not on Dialysis

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Percentage of patients maintaining average Hb concentration within target range of 10.5-12.5g/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 target range throughout evaluation period. [ Time Frame: Week 17-24 ] [ Designated as safety issue: No ]
Mean time in target 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:	200
Study Start Date:	March 2008
Estimated Study Completion Date:	February 2010

Arms	Assigned Interventions
1: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] 120, 200 or 360 micrograms sc 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;
stable darbepoetin alfa or epoetin beta therapy for past 8 weeks.

Exclusion Criteria:

transfusion of red blood cells during previous 8 weeks;
poorly controlled hypertension requiring interruption of epoetin treatment in previous 6 months;
acute or chronic bleeding requiring therapy within previous 8 weeks.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642304

Contacts

Contact: Please reference Study ID Number: ML20937	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

Netherlands
	Recruiting
MAASTRICHT, Netherlands, 6202
	Recruiting
HOOGEVEEN, Netherlands, 7909
	Recruiting
UTRECHT, Netherlands, 3582 KE
	Recruiting
GOUDA, Netherlands, 2803 HH
	Recruiting
ROTTERDAM, Netherlands, 3083 AN
	Recruiting
ROTTERDAM, Netherlands, 3078 HT
	Recruiting
DRACHTEN, Netherlands, 9202 NN
	Terminated
BEVERWIJK, Netherlands, 1942LE
	Recruiting
DOETINCHEM, Netherlands, 7009 BL
	Recruiting
ALMELO, Netherlands, 7600 SZ
	Recruiting
NIJMEGEN, Netherlands, 6525 GA
	Recruiting
TERNEUZEN, Netherlands, 4535 PA
	Recruiting
ROTTERDAM, Netherlands, 3015 GD
	Recruiting
AMERSFOORT, Netherlands, 3800 BM
	Recruiting
BREDA, Netherlands, 4818 CK
	Recruiting
DELFT, Netherlands, 2625 AD
	Terminated
LEIDERDORP, Netherlands, 2353 GA
	Recruiting
GOES, Netherlands, 4462 RA
	Recruiting
AMSTERDAM, Netherlands, 1034 CS
	Recruiting
HEERLEN, Netherlands, 6419 PC
	Recruiting
LEIDEN, Netherlands, 2333 ZA
	Recruiting
DORDRECHT, Netherlands, 3318 AT
	Recruiting
ASSEN, Netherlands, 9401 RK

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:	ML20937
Study First Received:	March 19, 2008
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00642304 History of Changes
Health Authority:	Netherlands:Medicines Evaluation Board

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