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A Study of Mircera in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis

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ClinicalTrials.gov Identifier: NCT00081471
Recruitment Status : Completed
First Posted : April 16, 2004
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will assess the efficacy and safety of subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Condition or disease Intervention/treatment Phase
Anemia Drug: darbepoetin alfa Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label Study of the Effect of Subcutaneous Mircera on Hemoglobin Level/Correction in Non-dialysis Patients With Chronic Kidney Disease
Study Start Date : June 2004
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

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Arm Intervention/treatment
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
0.6 micrograms/kg sc (starting dose) once every 2 weeks

Active Comparator: 2 Drug: darbepoetin alfa
0.45 micrograms/kg sc (starting dose) weekly




Primary Outcome Measures :
  1. Hemoglobin response rate [ Time Frame: Weeks 1-28 ]

Secondary Outcome Measures :
  1. Hb concentration over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, adverse events, laboratory values\n\n [ Time Frame: Throughout study ]


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

Inclusion Criteria:

  • adult patients >=18 years of age;
  • chronic kidney disease;
  • anemia;
  • not on dialysis therapy;
  • not receiving epoetin.

Exclusion Criteria:

  • women who are pregnant, breastfeeding or using unreliable birth control methods;
  • administration of another investigational drug within 4 weeks before screening, or during the study period.

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): NCT00081471


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00081471    
Other Study ID Numbers: BA16738
First Posted: April 16, 2004    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Anemia
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Darbepoetin alfa
Hematinics