A Study of Intravenous Mircera in Dialysis Patients With Chronic Renal Disease and Anemia. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00576303

Purpose

This single arm study will assess the efficacy, safety and tolerability of monthly intravenous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal disease, currently receiving epoetin alfa or beta. Patients will receive monthly intravenous injections of Mircera at a starting dose of 120, 200 or 360 micrograms/month, depending on the dose of epoetin alfa or 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 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 Study to Assess the Maintenance of Haemoglobin Levels, Safety and Tolerability of Monthly Administration of Intravenous Mircera in Dialysis Patients With Chronic Renal Disease and Anaemia Who Are Currently Receiving Epoetin Alfa or Beta.

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/L during evaluation period. [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Hb concentration over evaluation period [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
Percentage of patients maintaining Hb concentration in target range throughout evaluation period. [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
Mean time spent in Hb target range; mean number of months/subject requiring dose adjustments; incidence of RBC transfusions. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	March 2008
Estimated Study Completion Date:	May 2010

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;
hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months before and throughout screening period;
continuous maintenance epoetin alfa or beta therapy with the same dosing interval during the previous 2 months.

Exclusion Criteria:

transfusion of red blood cells during previous 2 months;
poorly controlled hypertension requiring interruption of epoetin alfa or beta treatment in past 6 months;
significant acute or chronic bleeding such as overt gastrointestinal bleeding;
hemolysis;
folic acid and vitamin B12 deficiency.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576303

Contacts

Contact: Please reference Study ID Number: ML20977	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

Russian Federation
	Active, not recruiting
MOSCOW, Russian Federation, 127006
	Active, not recruiting
ST PETERSBURG, Russian Federation, 195067
	Active, not recruiting
MOSCOW, Russian Federation, 117049
	Active, not recruiting
ST PETERSBURG, Russian Federation, 197089
	Not yet recruiting
TOMSK, Russian Federation, 634063
	Active, not recruiting
ST PETERSBURG, Russian Federation, 198510
	Active, not recruiting
MOSCOW, Russian Federation, 129110
	Recruiting
MOSCOW, Russian Federation, 129317
	Active, not recruiting
ST PETERSBURG, Russian Federation, 196247
	Recruiting
MOSCOW, Russian Federation, 123182
	Recruiting
NOVOSIBIRSK, Russian Federation, 630087
	Recruiting
OMSK, Russian Federation, 644111
	Active, not recruiting
KRASNODAR, Russian Federation, 350086
	Active, not recruiting
KEMEROVO, Russian Federation, 650061
	Recruiting
ST PETERSBURG, Russian Federation, 191015
	Recruiting
VOLZHSKY, Russian Federation, 404130
	Recruiting
MOSCOW, Russian Federation, 125101
	Recruiting
ST PETERSBURG, Russian Federation, 197110
	Active, not recruiting
EKATERINBURG, Russian Federation, 620102

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:	ML20977
Study First Received:	December 18, 2007
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00576303
Health Authority:	Russia: Federal Agency of Drug Quality Control

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