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MIRACLE Study: A Study Of Once-Monthly Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia.
This study is ongoing, but not recruiting participants.
Study NCT00545571   Information provided by Hoffmann-La Roche
First Received: October 16, 2007   Last Updated: April 15, 2009   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

October 16, 2007
April 15, 2009
October 2007
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 ]
Same as current
Complete list of historical versions of study NCT00545571 on ClinicalTrials.gov Archive Site
  • 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 ]
Efficacy: Change in Hb conc between reference and EEP; mean time spent in country-specific target range; % pts. maintaining Hb within country-specific target range;dose adjustments; RBC transfusions. Safety: AEs, lab parameters, vital signs.
 
MIRACLE Study: A Study Of Once-Monthly Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia.
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.

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.

 
Phase III
Interventional
Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Anemia
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
200
December 2009
 

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).
Both
18 Years and older
No
 
Austria,   Switzerland
 
 
NCT00545571
Clinical Trials, Study Director, Hoffmann-La Roche
 
Hoffmann-La Roche
 
Study Director: Clinical Trials Hoffmann-La Roche, +1 973 235 5000
Hoffmann-La Roche
April 2009

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.