A Study of Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia - Full Text View

Purpose

This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Patients will receive 4-weekly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms. 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 Dialysis Kidney Failure

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:	A Single Arm Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-Monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Haemodialysis Patients With Chronic Renal Anaemia.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

% patients maintaining mean Hb conc. within target range during the Efficacy Evaluation Period (EEP) [ Time Frame: Weeks 16-24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in mean Hb conc. [ Time Frame: Between reference and EEP ] [ Designated as safety issue: No ]
% patients maintaining Hb within target range [ Time Frame: Weeks 16-24 ] [ Designated as safety issue: No ]
% patients requiring dose adjustments; incidence of RBC transfusions [ Time Frame: Weeks 0-24 ] [ Designated as safety issue: No ]
AEs, lab parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

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

Arms	Assigned Interventions
1: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] 120, 200 or 360 micrograms iv every 4 weeks (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;
continuous stable iv or sc maintenance epoetin therapy during previous 4 weeks;
regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661505

Contacts


Contact: Please reference Study ID Number: RLI_ML21096	973-235-5000

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

Locations


Turkey
		Recruiting
	IZMIR, Turkey, 35100
		Recruiting
	IZMIR, Turkey, 35340
		Recruiting
	ISTANBUL, Turkey, 34662
		Recruiting
	ANKARA, Turkey, 06500
		Recruiting
	KAYSERI, Turkey, 38039
		Recruiting
	ANKARA, Turkey, 06100
		Recruiting
	ANKARA, Turkey, 06490
		Recruiting
	ERZURUM, Turkey, 25240
		Recruiting
	DIYARBAKIR, Turkey, 10000
		Not yet recruiting
	MERSIN, Turkey, 33169
		Recruiting
	ISTANBUL, Turkey, 34377
		Not yet recruiting
	MALATYA, Turkey, 44300
		Recruiting
	ADANA, Turkey, 01330
		Not yet recruiting
	AYDIN, Turkey, 09100
		Not yet recruiting
	EDIRNE, Turkey
		Not yet recruiting
	ELAZIG, Turkey, 23110
		Not yet recruiting
	ANKARA, Turkey, 06100
		Not yet recruiting
	ISTANBUL, Turkey, 34390

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:	ML21096
First Received:	April 16, 2008
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00661505
Health Authority:	Turkey: Ministry of Health

Study placed in the following topic categories:

Epoetin Alfa

Hematologic Diseases

Anemia

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00661505