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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00642668

Purpose

This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction and/or maintenance of hemoglobin levels in chronic kidney disease patients with renal anemia, who are not currently treated with ESA or on dialysis. Eligible patients will receive monthly subcutaneous injections of Mircera, at an initial recommended 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 IV

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:	An Open Label Study of the Safety, Tolerability and Effect on Hemoglobin Levels of Monthly Subcutaneous Mircera in Patients With Chronic Kidney Disease Not Treated With ESA or Dialysis.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Proportion of patients maintaining average hemoglobin concentration during Efficacy Evaluation Period (EEP)within target range [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in hemoglobin concentration between baseline and EEP [ Time Frame: Weeks 1-28 ] [ Designated as safety issue: No ]
Proportion of patients maintaining hemoglobin concentrations within range of 10-12g/dL throughout EEP [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]
Mean time spent in hemoglobin range of 10-12g/dL during EEP [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]
AEs, lab parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2009

Arms	Assigned Interventions
1: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] 1.2 micrograms/kg sc monthly (initial recommended dose)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

adult patients, >=18 years of age;
chronic renal anemia;
no ESA therapy during previous 3 months.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642668

Locations

Belgium

ANTWERPEN, Belgium, 2020

ANTWERPEN, Belgium, 2060

BRUXELLES, Belgium, 1020

BRUXELLES, Belgium, 1200

ROESELARE, Belgium, 8800

VERVIERS, Belgium, 4800

CHARLEROI, Belgium, 6000

GENT, Belgium, 9000

BONHEIDEN, Belgium, 2820

GENK, Belgium, 3600

LEUVEN, Belgium, 3000

EDEGEM, Belgium, 2650

BRUXELLES, Belgium, 1070

BRUXELLES, Belgium, 1090

BRUXELLES, Belgium, 1000

DENDERMONDE, Belgium, 9200

SINT NIKLAAS, Belgium, 9100

TOURNAI, Belgium, 7500

ASSEBROEK, Belgium, 8310

IEPER, Belgium, 8900

TURNHOUT, Belgium, 2300

GENT, Belgium, 9000

AALST, Belgium, 9300

LIÈGE, Belgium, 4000

HUY, Belgium, 4500

SINT NIKLAAS, Belgium, 9100

BRUXELLES, Belgium, 1180

HORNU, Belgium, 7301

BAUDOUR, Belgium, 7331

ATH, Belgium, 7800

BRUXELLES, Belgium, 1070

LIEGE, Belgium, 4000

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:	ML21348
Study First Received:	March 19, 2008
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00642668 History of Changes
Health Authority:	Belgium : Federal Agency for Medicines and health products

Study placed in the following topic categories:

Epoetin Alfa
Hematologic Diseases
Renal Insufficiency, Chronic

Anemia
Kidney Failure, Chronic
Kidney Diseases

Additional relevant MeSH terms:

Hematologic Diseases
Anemia

ClinicalTrials.gov processed this record on May 07, 2009