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A Study of Subcutaneous Mircera for the Treatment of Anemia in Pre-Dialysis Patients With Chronic Kidney Disease.

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00462384
First received: April 18, 2007
Last updated: July 19, 2011
Last verified: July 2011
History of Changes
  Purpose

This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia 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 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, Multi-center Study to Demonstrate Correction of Anemia and to Assess the Maintenance of Hemoglobin Levels Using Subcutaneous Once Monthly Injections of Mircera in Pre-dialysis Patients With Chronic Kidney Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Mean change in Hb concentration between baseline and evaluation period [ Time Frame: Weeks 29 to 36 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to achievement of response, and mean time spent in Hb range of 11-13g/dL [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Percentage of patients maintaining Hb concentration of 11-13g/dL throughout evaluation period [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: February 2008
Study Completion Date: April 2011
Arms Assigned Interventions
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
1.2 micrograms/kg sc 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 kidney disease, stage 3 or 4;
  • anemia (baseline Hb between 9 and 11g/dL).

Exclusion Criteria:

  • previous therapy with ESA within 12 weeks prior to screening;
  • overt gastrointestinal bleeding, or bleeding episode necessitating transfusion within 8 weeks before screening;
  • red blood cell transfusions within 8 weeks before screening;
  • active malignant disease (except non-melanoma skin cancer).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00462384

Locations
Estonia
Tallinn, Estonia, 13419
Tallinn, Estonia, 10617
Tartu, Estonia, 51014
Finland
HUS, Finland, 00029
Joensuu, Finland, 80210
Jyväskylä, Finland, 40620
Kajaani, Finland, 87140
Kotka, Finland, 48210
Porvoo, Finland, 06151
Tampere, Finland, 33521
Turku, Finland, 20521
Latvia
Jurmala, Latvia, LV2015
Liepaja, Latvia, 3402
Riga, Latvia, LV1038
Riga, Latvia, 1002
Valmiera, Latvia, 4201
Ventspils, Latvia, LV 3601
Norway
Honefoss, Norway, 3504
Lillehammer, Norway, 2629
Oslo, Norway, 0407
Stavanger, Norway, 4011
Trondheim, Norway, 7006
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: NCT00462384     History of Changes
Other Study ID Numbers: ML20659
Study First Received: April 18, 2007
Last Updated: July 19, 2011
Health Authority: Finland: National Agency of Medicines

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
 Hematologic Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on June 17, 2013