MIRACLE Study: A Study Of Once-Monthly Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00545571

Purpose

This single arm study will assess the long-term maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in hemodialysis patients with chronic renal anemia. Patients currently receiving darbepoetin alfa, epoetin alfa or epoetin beta maintenance treatment will receive intravenous Mircera at a starting dose of 120 or 200 micrograms/month (based on the ESA dose administered on week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the country-specific target range (11-13g/dL for Switzerland and 10-12g/dL for Austria). The anticipated time on study treatment is 1-2 years, 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

Drug Information available for: 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, Interventional Multicenter Study to 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.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Percentage of patients maintaining average Hb concentration within country-specific target range (11-13g/dL for Switzerland and 10-12g/dL for Austria) OR +/- 1g/dL of reference Hb concentration during evaluation period. [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Hb concentration between reference and evaluation period [ Time Frame: Week 17-24 ] [ Designated as safety issue: No ]
Mean time spent in country-specific target range; percentage of patients maintaining Hb within target range; dose adjustments; RBC transfusions. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
AEs, laboratory parameters, vital signs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	October 2007
Estimated Study Completion Date:	December 2009

Arms	Assigned Interventions
1: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] 120 or 200 micrograms iv monthly, 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;
Hb conc. in country-specific target range (Switzerland: 11g/dL-13g/dL; Austria: 10g/dL-12g/dL);
regular long-term hemodialysis therapy with the same mode of dialysis for >=3 months;
continuous iv or sc maintenance ESA treatment during previous 2 months.

Exclusion Criteria:

transfusion of red blood cells during previous 2 months;
significant acute or chronic bleeding, such as overt gastrointestinal bleeding;
active malignant disease (except non-melanoma skin cancer).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545571

Contacts

Contact: Please reference Study ID Number: RLI_ML20826	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

Austria
	Active, not recruiting
GRAZ, Austria, 8020
	Active, not recruiting
WIEN, Austria, 1160
	Active, not recruiting
WIEN, Austria, 1100
	Active, not recruiting
WIEN, Austria, 1030
	Active, not recruiting
WIEN, Austria, 1220
	Active, not recruiting
KUFSTEIN, Austria, 6330
	Active, not recruiting
BREGENZ, Austria, 6900
	Active, not recruiting
STEYR, Austria, 4400
	Active, not recruiting
LINZ, Austria, 4020
	Active, not recruiting
ST PÖLTEN, Austria, 3100
	Active, not recruiting
WIEN, Austria, 1130
	Recruiting
FELDKIRCH, Austria, 6807
	Active, not recruiting
SALZBURG, Austria, 5020
Switzerland
	Active, not recruiting
ST GALLEN, Switzerland, 9007
	Active, not recruiting
LAUSANNE, Switzerland, 1011
	Active, not recruiting
BELLINZONA, Switzerland, 6500
	Active, not recruiting
LOCARNO, Switzerland, 6600
	Active, not recruiting
MENDRISIO, Switzerland, 6850
	Active, not recruiting
BURGDORF, Switzerland, 3400
	Active, not recruiting
LIESTAL, Switzerland, 4410
	Active, not recruiting
SION, Switzerland, 1951
	Recruiting
ZÜRICH, Switzerland, 8091
	Recruiting
GENEVE, Switzerland, 1205
	Active, not recruiting
ZÜRICH, Switzerland, 8037
	Active, not recruiting
LUGANO, Switzerland, 6903
	Active, not recruiting
BASEL, Switzerland, 4031

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:	ML20826
Study First Received:	October 16, 2007
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00545571
Health Authority:	Switzerland: Swissmedic

Study placed in the following topic categories:

Epoetin Alfa
Hematologic Diseases
Anemia

ClinicalTrials.gov processed this record on January 14, 2009