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A Study of Subcutaneous Mircera for the Treatment of Anemia in Pre-Dialysis Patients.

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00576628
First received: December 18, 2007
Last updated: June 15, 2011
Last verified: June 2011
History of Changes
  Purpose

This single arm study will assess the efficacy, safety and tolerability of subcutaneous Mircera for correction of anemia and maintenance of hemoglobin levels in patients with chronic kidney disease who are not on dialysis and are not treated with ESA. Eligible patients will receive Mircera by monthly subcutaneous injections, dependent on body weight (with a recommended starting 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 to Assess the Effect on Anemia Correction, Maintenance of Haemoglobin Levels, Safety and Tolerability of Monthly Administration of Subcutaneous Mircera in Pre-dialysis Patients With Chronic Renal Anemia Not Currently Treated With ESA.

Resource links provided by NLM:

MedlinePlus related topics: Anemia Dialysis
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in Hb concentration between screening and evaluation period [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients maintaining average Hb concentration of 11.0-13.0g/dL throughout evaluation period. [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]
  • Mean time spent in target Hb range; mean number of months/subject requiring any dose adjustment; RBC transfusions. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 126
Study Start Date: April 2008
Study Completion Date: January 2011
Arms Assigned Interventions
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Recommended starting dose 1.2 micrograms/kg sc monthly

  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, with no need for dialysis expected in next 3 months;
  • adequate iron status.

Exclusion Criteria:

  • previous epoetin therapy within 12 weeks prior to treatment;
  • transfusion of red blood cells during 2 months prior to screening;
  • significant acute or chronic bleeding such as overt gastrointestinal bleeding;
  • hemolysis;
  • folic acid and vitamin B 12 deficiency.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576628

Locations
Russian Federation
Ekaterinburg, Russian Federation, 620102
Irkutsk, Russian Federation, 664079
Khabarovsk, Russian Federation, 680009
Khanty-mansiysk, Russian Federation, 628011
Moscow, Russian Federation, 117036
Moscow, Russian Federation, 125315
Moscow, Russian Federation, 129110
Moscow, Russian Federation, 125101
Moscow, Russian Federation, 123182
Nizhny Novgorod, Russian Federation, 603126
Nizhny Novgorod, Russian Federation, 603001
Omsk, Russian Federation, 644112
Orenburg, Russian Federation, 460018
Rostov-na-donu, Russian Federation, 344029
Saratov, Russian Federation, 410053
St Petersburg, Russian Federation, 195067
St Petersburg, Russian Federation, 194354
St Petersburg, Russian Federation, 197110
St Petersburg, Russian Federation, 197089
Tjumen, Russian Federation, 625023
UFA, Russian Federation, 450005
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00576628     History of Changes
Other Study ID Numbers: ML20978
Study First Received: December 18, 2007
Last Updated: June 15, 2011
Health Authority: Russia: Federal Agency of Drug Quality Control

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on May 21, 2013