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:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

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 ]

Enrollment:	132
Study Start Date:	May 2008
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	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

Locations

Turkey

Adana, Turkey, 01330

Ankara, Turkey, 06490

Ankara, Turkey, 06500

Ankara, Turkey, 06100

Aydin, Turkey, 09100

Diyarbakir, Turkey, 10000

Edirne, Turkey, 22030

Elazig, Turkey, 23110

Erzurum, Turkey, 25240

Istanbul, Turkey, 34662

Istanbul, Turkey, 34390

Istanbul, Turkey, 34377

Izmir, Turkey

Izmir, Turkey, 35290

Kayseri, Turkey, 38039

Malatya, Turkey, 44300

Mersin, Turkey, 33169

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00661505 History of Changes
Other Study ID Numbers:	ML21096
Study First Received:	April 16, 2008
Last Updated:	July 19, 2011
Health Authority:	Turkey: Ministry of Health

Additional relevant MeSH terms:

Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on February 13, 2012