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

This study has been terminated.
(Strategic decision unrelated to safety or efficacy)
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00462384
First received: April 18, 2007
Last updated: March 2, 2016
Last verified: March 2016
  Purpose
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 Intervention Phase
Anemia
Drug: Methoxy Polyethylene Glycol-epoetin Beta
Phase 3

Study Type: Interventional
Study Design: 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:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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:
  • Time to Achievement of Response [ Time Frame: Baseline to Week 40 ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • Time Spent in Hemoglobin Range of 11.0 to 13.0 g/dL During the EEP [ Time Frame: EEP (Weeks 29 to 36) ] [ Designated as safety issue: No ]
    EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period.


Enrollment: 39
Study Start Date: February 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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 
Study First Received: April 18, 2007
Results First Received: March 2, 2016
Last Updated: March 2, 2016
Health Authority: Finland: National Agency of Medicines

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

ClinicalTrials.gov processed this record on May 04, 2016