A Study for Monthly Methoxy Polyethylene Glycol-Epoetin Beta Treatment in Patients With Chronic Renal Anaemia
NCT ID: NCT01066000
Last Updated: 2017-11-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE4
33 participants
INTERVENTIONAL
2009-10-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Mircera
methoxy polyethylene glycol-epoetin beta [Mircera]
initial doses of either 120 micrograms or 200 micrograms or 360 micrograms, once monthly
Interventions
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methoxy polyethylene glycol-epoetin beta [Mircera]
initial doses of either 120 micrograms or 200 micrograms or 360 micrograms, once monthly
Eligibility Criteria
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Inclusion Criteria
* Chronic renal anaemia
* Haemoglobin concentration between 10 and 12 g/dL at screening
* Adequate iron status
* Continuous intravenous maintenance short-acting therapy with same dosing interval for 8 weeks prior to screening
* Regular long-term haemodialysis therapy for at least 12 weeks prior to screening
Exclusion Criteria
* Transfusion of red blood cells less than 8 weeks prior to screening
* Poorly controlled hypertension
* Relevant acute or chronic bleeding requiring treatment less than 8 weeks prior to screening
* Active malignant disease
* Haemolysis
* Haemoglobinopathies
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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Advent Hospital; Kidney and Hipertension
Bandung, , Indonesia
Sanglah Hospital; Kidney and Hipertension
Denpasar, , Indonesia
Rumah Sakit Pgi Cikini; Renal & Hypertension
Jakarta, , Indonesia
Cipto Mangunkusumo Hospital; Renal and Hypertension division, Internal Medecine Department
Jakarta, , Indonesia
Pelni Hospital; Kidney and Hipertension
Jakarta, , Indonesia
Pondok Indah Hospital; Kidney and Hipertension
Jakarta, , Indonesia
Pantai Indah Kapuk Hospital; Kidney and Hipertension
Jakarta, , Indonesia
Klinik Spesialis Ginjal dan hipertensi Rasyida; Renal and Hypertension
Medan, , Indonesia
Pirngadi; Renal and Hypertension
Medan, , Indonesia
Telogorejo Hospital; Renal and Hypertension
Semarang, , Indonesia
Dokter Soetomo Hospital
Surabaya, , Indonesia
PHC Hospital; Renal and Hypertension
Surabaya, , Indonesia
Countries
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Other Identifiers
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ML21736
Identifier Type: -
Identifier Source: org_study_id