MIRACLE Study: A Study Of Once-Monthly 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:	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

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

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:

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 ]

Enrollment:	91
Study Completion Date:	November 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

Locations

Austria

Graz, Austria, 8020

Wien, Austria, 1160

Wien, Austria, 1100

Wien, Austria, 1030

Wien, Austria, 1220

Kufstein, Austria, 6330

Bregenz, Austria, 6900

Steyr, Austria, 4400

Linz, Austria, 4020

St Pölten, Austria, 3100

Wien, Austria, 1130

Feldkirch, Austria, 6807

Salzburg, Austria, 5020
Switzerland

St Gallen, Switzerland, 9007

Lausanne, Switzerland, 1011

Bellinzona, Switzerland, 6500

Locarno, Switzerland, 6600

Mendrisio, Switzerland, 6850

Burgdorf, Switzerland, 3400

Liestal, Switzerland, 4410

Sion, Switzerland, 1951

Luzern, Switzerland, 6004

Zürich, Switzerland, 8091

Geneve, Switzerland, 1205

Zürich, Switzerland, 8037

Lugano, Switzerland, 6903

Basel, Switzerland, 4031

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:	ML20826
Study First Received:	October 16, 2007
Last Updated:	January 15, 2010
ClinicalTrials.gov Identifier:	NCT00545571 History of Changes
Health Authority:	Switzerland: Swissmedic

Additional relevant MeSH terms:

Hematologic Diseases
Anemia

ClinicalTrials.gov processed this record on February 08, 2010