A Study of Subcutaneous Mircera, Versus no Erythropoiesis-Stimulating Agent (ESA) Therapy, in the Treatment of Anemia in Patients With Chronic Kidney Disease After Kidney Transplant
NCT ID: NCT00576602
Last Updated: 2016-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
1 participants
INTERVENTIONAL
2007-12-31
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
methoxy polyethylene glycol-epoetin beta [Mircera]
Recommended starting dose of 0.6 micrograms/kg sc every 2 weeks
2
Supportive treatment
As prescribed
Interventions
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methoxy polyethylene glycol-epoetin beta [Mircera]
Recommended starting dose of 0.6 micrograms/kg sc every 2 weeks
Supportive treatment
As prescribed
Eligibility Criteria
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Inclusion Criteria
* kidney transplant \>=6 months and \<5 years prior to randomization;
* anemia;
* no ESA therapy during 3 months prior to randomization.
Exclusion Criteria
* change in Hb concentration \>=1.5g/dL during screening period;
* transfusion of red blood cells during 3 months prior to randomization;
* poorly controlled hypertension;
* significant acute or chronic bleeding within 3 months prior to randomization.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Edegem, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Amiens, , France
Caen, , France
Le Kremlin-Bicêtre, , France
Nice, , France
Paris, , France
Toulouse, , France
Tours, , France
Berlin, , Germany
Frankfurt am Main, , Germany
Kaiserslautern, , Germany
Kiel, , Germany
München, , Germany
Bari, , Italy
Barcelona, , Spain
Santander, , Spain
Seville, , Spain
London, , United Kingdom
Countries
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Other Identifiers
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MH21299
Identifier Type: -
Identifier Source: org_study_id