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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00545571
First received: October 16, 2007
Last updated: August 13, 2013
Last verified: August 2013
  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 3

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, 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:


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 Start Date: October 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Austria
Bregenz, Austria, 6900
Feldkirch, Austria, 6807
Graz, Austria, 8020
Kufstein, Austria, 6330
Linz, Austria, 4020
Salzburg, Austria, 5020
St Pölten, Austria, 3100
Steyr, Austria, 4400
Wien, Austria, 1100
Wien, Austria, 1160
Wien, Austria, 1030
Wien, Austria, 1220
Wien, Austria, 1130
Switzerland
Basel, Switzerland, 4031
Bellinzona, Switzerland, 6500
Burgdorf, Switzerland, 3400
Geneve, Switzerland, 1205
Lausanne, Switzerland, 1011
Liestal, Switzerland, 4410
Locarno, Switzerland, 6600
Lugano, Switzerland, 6903
Luzern, Switzerland, 6004
Mendrisio, Switzerland, 6850
Sion, Switzerland, 1951
St. Gallen, Switzerland, 9007
Zürich, Switzerland, 8037
Zürich, Switzerland, 8091
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00545571     History of Changes
Other Study ID Numbers: ML20826
Study First Received: October 16, 2007
Last Updated: August 13, 2013
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on September 30, 2014