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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00680563
First received: May 16, 2008
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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 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: 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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Mean change in Hb concentration between baseline and Efficacy Evaluation Period (EEP). [ Time Frame: Week 32 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to achievement of response [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Percentage of patients whose Hb concentration remains within range 10.0-12.0g/dL [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Percentage of patients whose average Hb concentration is within range 10.0 - 12.0g/dL [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Mean time spent in Hb range of 10.0 - 12.0g/dL [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Percentage of patients requiring dose adjustments; incidence of RBC transfusions; time to initiation of renal replacement therapy. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: April 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
sc every month (starting dose 1.2 micrograms/kg)

  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;
  • 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.
  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: NCT00680563

Locations
Argentina
Buenos Aires, Argentina, CP2700
La Plata, Argentina, 1900
Tucuman, Argentina, 4000
Brazil
Blumenau, Brazil, 89010-500
Botucatu, Brazil, 18618-000
Curitiba, Brazil, 80250-070
Rio de Janeiro, Brazil, 20551-030
Sao Paulo, Brazil, 04039-901
Sao Paulo, Brazil, 01246-903
Chile
Santiago, Chile, 8900000
Santiago de Chile, Chile, 056
Colombia
Barranquilla, Colombia, 575
Cali, Colombia, 572
Envigado, Colombia, 571
Medellin, Colombia, 0
Costa Rica
San Jose, Costa Rica
Ecuador
Quito, Ecuador, 2569
Guatemala
Guatemala City, Guatemala
Panama
Panama City, Panama
Peru
Lima, Peru, L13
San Isidro, Peru, Lima 27
Venezuela
Caracas, Venezuela, 1020
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: NCT00680563     History of Changes
Other Study ID Numbers: ML21467
Study First Received: May 16, 2008
Last Updated: November 4, 2013
Health Authority: Brazil: Ministry of Health

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on August 26, 2014