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

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.
ClinicalTrials.gov Identifier: NCT00462384
Recruitment Status : Terminated (Strategic decision unrelated to safety or efficacy)
First Posted : April 19, 2007
Results First Posted : April 1, 2016
Last Update Posted : April 1, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in participants with chronic kidney disease who are not on dialysis and are not treated with erythropoiesis-stimulating agents (ESA). Eligible participants will receive Mircera by monthly subcutaneous injections, dependent on body weight (with a starting dose of 1.2 micrograms/kilogram [mcg/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 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2008
Primary Completion Date : April 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Methoxy Polyethylene Glycol-epoetin Beta
Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose will be 1.2 micrograms per kilogram (mcg/kg) body weight. Thereafter, throughout the duration of study the dose adjustments will be performed depending on the hemoglobin value.
Drug: Methoxy Polyethylene Glycol-epoetin Beta
Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose will be 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments will be performed depending on the hemoglobin value.
Other Names:
  • Mircera
  • RO0503821


Outcome Measures

Primary Outcome Measures :
  1. Mean Change in Hemoglobin Concentration Between Baseline and the Efficacy Evaluation Period (EEP) [ Time Frame: Baseline (Week -2 to 0) and EEP (Weeks 29 to 36) ]
    The baseline hemoglobin was defined as the mean of the assessments recorded during the screening period (Weeks -2 and 0). EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. EEP hemoglobin was defined as the mean of the assessments recorded during the EEP.


Secondary Outcome Measures :
  1. Time to Achievement of Response [ Time Frame: Baseline to Week 40 ]
    Time to achievement of response was the time (number of days) required to achieve hemoglobin levels within the range of 11.0 to 13.0 g/dL.

  2. Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL Throughout the EEP [ Time Frame: EEP (Weeks 29 to 36) ]
    EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose hemoglobin concentrations remained within the range of 11.0-13.0 g/dL at all assessments throughout the EEP is presented.

  3. Percentage of Participants Maintaining Average Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL During the EEP [ Time Frame: EEP (Weeks 29 to 36) ]
    EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose average hemoglobin concentration was within the range of 11.0-13.0 g/dL during the EEP is presented.

  4. Time Spent in Hemoglobin Range of 11.0 to 13.0 g/dL During the EEP [ Time Frame: EEP (Weeks 29 to 36) ]
    EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period.


Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • chronic kidney disease, stage 3 or 4;
  • anemia (baseline hemoglobin between 9 and 11 grams per deciliter [g/dL]).

Exclusion Criteria:

  • previous therapy with ESA within 12 weeks prior to screening;
  • significant acute or chronic bleeding such as overt gastrointestinal bleeding;
  • red blood cell transfusions within 8 weeks before screening;
  • active malignant disease (except non-melanoma skin cancer).
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00462384


Locations
Estonia
Tallinn, Estonia, 10617
Tallinn, Estonia, 13419
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, 1002
Riga, Latvia, LV1038
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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00462384     History of Changes
Other Study ID Numbers: ML20659
First Posted: April 19, 2007    Key Record Dates
Results First Posted: April 1, 2016
Last Update Posted: April 1, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Epoetin Alfa
Hematinics