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

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

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

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, 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.

Resource links provided by NLM:

MedlinePlus related topics: Anemia Dialysis Kidney Failure

Drug Information available for: Epoetin beta

U.S. FDA Resources

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:	September 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: ML21096

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Locations

Turkey
	Recruiting
Izmir, Turkey, 35290
	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
	Recruiting
Malatya, Turkey, 44300
	Recruiting
Adana, Turkey, 01330
	Recruiting
Aydin, Turkey, 09100
	Recruiting
Edirne, Turkey, 22030
	Recruiting
Elazig, Turkey, 23110
	Not yet recruiting
Ankara, Turkey, 06100
	Recruiting
Istanbul, Turkey, 34390

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Disclosures Group )
Study ID Numbers:	ML21096
Study First Received:	April 16, 2008
Last Updated:	November 17, 2009
ClinicalTrials.gov Identifier:	NCT00661505 History of Changes
Health Authority:	Turkey: Ministry of Health

Additional relevant MeSH terms:

Hematologic Diseases
Anemia

ClinicalTrials.gov processed this record on November 25, 2009