A Study of Once Monthly Intravenous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00737464

Purpose

This single arm study will evaluate the maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in dialysis patients with chronic renal anemia. Patients will receive intravenous Mircera (120, 200 or 360 micrograms) every four weeks depending on the previous dose of epoetin alfa administered in the week preceding first study drug administration. Patients will be treated for 12 weeks with follow up 2 weeks after the last treatment visit. 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 IV

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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Proportion of patients maintaining Hb levels within the target range during the last 4 weeks of the treatment period. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in mean Hb concentration between reference and the last 4 weeks of the treatment period; mean time spent in Hb range 10.0g/dL - 12.0g/dL. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Incidence of adverse events, serious adverse events and deaths; vital signs, laboratory parameters, ECG. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	170
Estimated Study Completion Date:	June 2009

Arms	Assigned Interventions
1: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] iv (120, 200 or 360 micrograms) every 4 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

male or female patients, >=18 years of age;
chronic renal anemia;
Hb concentration 10.5g/dL - 12.5g/dL;
continuous intravenous maintenance therapy with epoetin alfa at the same dosing interval during the previous 2 months.

Exclusion Criteria:

blood transfusion within the previous 2 months;
poorly controlled hypertension;
significant acute or chronic bleeding;
active malignant disease;
congestive heart failure (NYHA Class IV).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737464

Contacts

Contact: Please reference Study ID Number: ML21810	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

India
	Not yet recruiting
KOLKATA, India, 700029
	Recruiting
NEW DELHI, India, 110076
	Recruiting
HYDERABAD, India, 500068
	Not yet recruiting
HYDERABAD, India, 500082
	Not yet recruiting
KOLKATA, India, 700027
	Not yet recruiting
CHENNAI, India, 600089
	Not yet recruiting
NEW DELHI, India, 110070
	Not yet recruiting
KANPUR, India, 208005
	Not yet recruiting
MUMBAI, India, 400092
	Not yet recruiting
BANGALORE, India, 560017
	Not yet recruiting
BANGALORE, India, 560024
	Not yet recruiting
MUMBAI, India, 400080
	Not yet recruiting
GUWAHATI, India, 781005
	Not yet recruiting
CHENNAI, India, 600037
	Not yet recruiting
MEERUT, India, 250001
	Not yet recruiting
MOHALI, India, 160 063

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:	ML21810
Study First Received:	August 18, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00737464
Health Authority:	India: Ministry of Health

Study placed in the following topic categories:

Epoetin Alfa
Hematologic Diseases
Anemia

ClinicalTrials.gov processed this record on January 14, 2009