A Study of Two-Weekly Intravenous Mircera for the Treatment of Dialysis Patients With Chronic Renal Anemia Not Receiving ESA Therapy. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00737711

Purpose

This single arm study will evaluate the hemoglobin (Hb) increasing effect, safety and tolerability of two-weekly intravenous administration of Mircera in dialysis patients with chronic renal anemia not currently treated with ESAs. Patients will receive intravenous Mircera 0.6 micrograms/kg every 2 weeks for 16 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 Two Weekly Administration of Intravenous MIRCERA for the Treatment of Chronic Renal Anaemia in Dialysis Patients Not Currently Treated With ESA.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Mean change in Hb concentration from baseline to last visit [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to achievement of response (Hb target range 10.0g/dL - 12g/dL); percentage of patients with average Hb concentration between 10.0g/dL and 12.0g/dL during that last 4 weeks of treatment. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Mean time spent in the Hb range 10.0g/dL - 12.0g/dL during the last 4 weeks of treatment. [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Incidence of AEs, SAEs and deaths; vital signs, laboratory parameters, ECG. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	170
Study Start Date:	July 2008
Estimated Study Completion Date:	June 2009

Arms	Assigned Interventions
1: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] iv 0.6 micrograms/kg every 2 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 8.0g/dL - 10.0g/dL);
no prior erythropoietin stimulating agent (ESA) therapy.

Exclusion Criteria:

blood transfusion within the previous 4 weeks;
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: NCT00737711

Contacts

Contact: Please reference Study ID Number: ML21822	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

India
	Recruiting
NEW DELHI, India, 110026
	Not yet recruiting
VELLORE, India, 632 004
	Recruiting
NEW DELHI, India, 110017
	Not yet recruiting
VISHAKPATNAM, India, 530002
	Recruiting
COIMBATORE, India, 641014
	Recruiting
AHMEDABAD, India, 380007
	Recruiting
CHENNAI, India, 603103
	Not yet recruiting
HYDERABAD, India, 500001
	Not yet recruiting
BANGALORE, India, 560034
	Not yet recruiting
KOLKATA, India, 700099
	Not yet recruiting
MUMBAI, India, 400026
	Recruiting
LUDHIANA, India
	Not yet recruiting
MUMBAI, India
	Recruiting
GUJARAT, India, 387 001
	Not yet recruiting
NEW DELHI, India, 110 060
	Recruiting
KERALA, India, 682017

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:	ML21822
Study First Received:	August 18, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00737711
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