A Study of Subcutaneous Mircera for the Treatment of Anemia in Pre-Dialysis Patients With Chronic Kidney Disease. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00462384

Purpose

This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in patients with chronic kidney disease who are not on dialysis and are not treated with ESA. Eligible patients will receive Mircera by monthly subcutaneous injections, dependent on body weight (with a starting dose of 1.2 micrograms/kg). 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 alfa Erythropoietin Epoetin beta

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Multi-Center Study to Demonstrate Correction of Anemia and to Assess the Maintenance of Hemoglobin Levels Using Subcutaneous Once Monthly Injections of Mircera in Pre-Dialysis Patients With Chronic Kidney Disease

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Mean change in Hb concentration between baseline and evaluation period [ Time Frame: Weeks 29 to 36 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to achievement of response, and mean time spent in Hb range of 11-13g/dL [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Percentage of patients maintaining Hb concentration of 11-13g/dL throughout evaluation period [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	February 2008
Estimated Study Completion Date:	September 2010

Arms	Assigned Interventions
1: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] 1.2 micrograms/kg 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 kidney disease, stage 3 or 4;
anemia (baseline Hb between 9 and 11g/dL).

Exclusion Criteria:

previous therapy with ESA within 12 weeks prior to screening;
overt gastrointestinal bleeding, or bleeding episode necessitating transfusion within 8 weeks before screening;
red blood cell transfusions within 8 weeks before screening;
active malignant disease (except non-melanoma skin cancer).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00462384

Contacts

Contact: Please reference Study ID Number: ML20659	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

Estonia
	Active, not recruiting
TALLINN, Estonia, 13419
	Active, not recruiting
TALLINN, Estonia, 10617
	Active, not recruiting
TARTU, Estonia, 51014
Finland
	Recruiting
TURKU, Finland, 20521
	Recruiting
TAMPERE, Finland, 33521
	Recruiting
HUS, Finland, 00029
	Recruiting
KAJAANI, Finland, 87140
	Recruiting
JYVAESKYLAE, Finland, 40620
	Recruiting
KOTKA, Finland, 48210
	Recruiting
PORVOO, Finland, 06151
	Not yet recruiting
KUOPIO, Finland, 70211
Latvia
	Active, not recruiting
RIGA, Latvia, 1002
	Active, not recruiting
JURMALA, Latvia, LV2015
	Terminated
RIGA, Latvia, LV1038
	Active, not recruiting
LIEPAJA, Latvia, 3402
	Active, not recruiting
VALMIERA, Latvia, 4201
	Active, not recruiting
VENTSPILS, Latvia, LV 3601
Norway
	Active, not recruiting
OSLO, Norway, 0407
	Active, not recruiting
STAVANGER, Norway, 4011
	Not yet recruiting
NORDBYHAGEN, Norway, 1474
	Active, not recruiting
LILLEHAMMER, Norway, 2629
	Not yet recruiting
ORKANGER, Norway, 7300
	Active, not recruiting
HONEFOSS, Norway, 3504
	Active, not recruiting
TRONDHEIM, Norway, 7006

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:	ML20659
Study First Received:	April 18, 2007
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00462384
Health Authority:	Finland: National Agency of Medicines

Study placed in the following topic categories:

Epoetin Alfa
Renal Insufficiency
Urologic Diseases
Hematologic Diseases
Renal Insufficiency, Chronic

Anemia
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on January 16, 2009