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

Purpose

This single arm study will assess the efficacy, safety and tolerability of subcutaneous Mircera for correction of anemia and maintenance of hemoglobin levels 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 recommended 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

ChemIDplus related topics:

Epoetin alfa Erythropoietin Epoetin beta

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	An Open Label Study to Assess the Effect on Anemia Correction, Maintenance of Haemoglobin Levels, Safety and Tolerability of Monthly Administration of Subcutaneous Mircera in Pre-Dialysis Patients With Chronic Renal Anemia Not Currently Treated With ESA.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Change in Hb concentration between screening and evaluation period [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of patients maintaining average Hb concentration of 11.0-13.0g/dL throughout evaluation period. [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]
Mean time spent in target Hb range; mean number of months/subject requiring any dose adjustment; 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:	April 2008
Estimated Study Completion Date:	February 2010

Arms	Assigned Interventions
1: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Recommended starting dose 1.2 micrograms/kg sc monthly

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, with no need for dialysis expected in next 3 months;
adequate iron status.

Exclusion Criteria:

previous epoetin therapy within 12 weeks prior to treatment;
transfusion of red blood cells during 2 months prior to screening;
significant acute or chronic bleeding such as overt gastrointestinal bleeding;
hemolysis;
folic acid and vitamin B 12 deficiency.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576628

Contacts


Contact: Please reference Study ID Number: RLI_ML20978	973-235-5000

Contact: or	800-526-6367 (FOR US ONLY)

Locations


Russian Federation
		Recruiting
	ROSTOV-NA-DONU, Russian Federation, 344029
		Recruiting
	ST PETERSBURG, Russian Federation, 195067
		Recruiting
	NIZHNY NOVGOROD, Russian Federation, 603001
		Active, not recruiting
	MOSCOW, Russian Federation, 129110
		Recruiting
	OMSK, Russian Federation, 644112
		Recruiting
	SARATOV, Russian Federation, 410053
		Recruiting
	IRKUTSK, Russian Federation, 664079
		Recruiting
	TJUMEN, Russian Federation, 625023
		Recruiting
	ORENBURG, Russian Federation, 460018
		Recruiting
	EKATERINBURG, Russian Federation, 620102
		Not yet recruiting
	KHABAROVSK, Russian Federation, 680009
		Recruiting
	NIZHNY NOVGOROD, Russian Federation, 603126
		Recruiting
	MOSCOW, Russian Federation, 117036
		Recruiting
	MOSCOW, Russian Federation, 125315
		Recruiting
	ST PETERSBURG, Russian Federation, 194354
		Recruiting
	MOSCOW, Russian Federation, 125101
		Recruiting
	MOSCOW, Russian Federation, 123182
		Recruiting
	KHANTY-MANSIYSK, Russian Federation, 628011
		Recruiting
	ST PETERSBURG, Russian Federation, 197089
		Recruiting
	UFA, Russian Federation, 450005

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:	ML20978
First Received:	December 18, 2007
Last Updated:	August 18, 2008
ClinicalTrials.gov Identifier:	NCT00576628
Health Authority:	Russia: Federal Agency of Drug Quality Control

Study placed in the following topic categories:

Epoetin Alfa

Hematologic Diseases

Anemia

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00576628