A Study of Once-Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Pre-Dialysis Patients Not Currently Treated With ESA.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00680563
Recruitment Status : Terminated
First Posted : May 20, 2008
Last Update Posted : November 5, 2013
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This single arm study will assess the efficacy and safety of subcutaneous Mircera for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with ESA. Eligible patients will receive monthly subcutaneous injections at an initial recommended dose of 1.2 micrograms/kg. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Condition or disease Intervention/treatment Phase
Anemia Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study of the Safety, Tolerability and Effect on Hemoglobin Levels of Once-monthly Subcutaneous Mircera in Predialysis Patients With Chronic Renal Anemia Not Currently Treated With ESA.
Study Start Date : April 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arm Intervention/treatment
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
sc every month (starting dose 1.2 micrograms/kg)

Primary Outcome Measures :
  1. Mean change in Hb concentration between baseline and Efficacy Evaluation Period (EEP). [ Time Frame: Week 32 ]

Secondary Outcome Measures :
  1. Time to achievement of response [ Time Frame: Throughout study ]
  2. Percentage of patients whose Hb concentration remains within range 10.0-12.0g/dL [ Time Frame: Throughout study ]
  3. Percentage of patients whose average Hb concentration is within range 10.0 - 12.0g/dL [ Time Frame: Throughout study ]
  4. Mean time spent in Hb range of 10.0 - 12.0g/dL [ Time Frame: Throughout study ]
  5. Percentage of patients requiring dose adjustments; incidence of RBC transfusions; time to initiation of renal replacement therapy. [ Time Frame: Throughout study ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • chronic renal anemia;
  • no ESA therapy during previous 3 months;
  • adequate iron status;
  • rapid chronic kidney disease progression.

Exclusion Criteria:

  • transfusion of red blood cells during previous 2 months;
  • poorly controlled hypertension requiring hospitalization in previous 6 months;
  • significant acute or chronic bleeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00680563

Buenos Aires, Argentina, CP2700
La Plata, Argentina, 1900
Tucuman, Argentina, 4000
Blumenau, Brazil, 89010-500
Botucatu, Brazil, 18618-000
Curitiba, Brazil, 80250-070
Rio de Janeiro, Brazil, 20551-030
Sao Paulo, Brazil, 01246-903
Sao Paulo, Brazil, 04039-901
Santiago de Chile, Chile, 056
Santiago, Chile, 8900000
Barranquilla, Colombia, 575
Cali, Colombia, 572
Envigado, Colombia, 571
Medellin, Colombia, 0
Costa Rica
San Jose, Costa Rica
Quito, Ecuador, 2569
Guatemala City, Guatemala
Panama City, Panama
Lima, Peru, L13
San Isidro, Peru, Lima 27
Caracas, Venezuela, 1020
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT00680563     History of Changes
Other Study ID Numbers: ML21467
First Posted: May 20, 2008    Key Record Dates
Last Update Posted: November 5, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Hematologic Diseases